<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02975804</url>
  </required_header>
  <id_info>
    <org_study_id>14150171</org_study_id>
    <nct_id>NCT02975804</nct_id>
  </id_info>
  <brief_title>RCT on Interactive Computer Play on Trunk Control in CP</brief_title>
  <official_title>Effectiveness of Interactive Computer Play on Trunk Control and Gross Motor Function in Children With Cerebral Palsy: a Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Manchester Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives:&#xD;
&#xD;
      This proposal is to investigate the effect of a 6-week training programme using an&#xD;
      Interactive computer play (ICP) on the trunk control, balance and gross motor function in&#xD;
      children with cerebral palsy (CP).&#xD;
&#xD;
      Hypothesis to be tested:&#xD;
&#xD;
      The trunk control, balance and gross motor function of children with CP will be significantly&#xD;
      improved after the ICP programme.&#xD;
&#xD;
      Design and subjects:&#xD;
&#xD;
      20 children (6 to 12 years old) with CP will be recruited in this pilot randomised controlled&#xD;
      trial. The children will be randomly allocated into a control or treatment group (10 children&#xD;
      in each arm).&#xD;
&#xD;
      Study instruments:&#xD;
&#xD;
      Tymo is a wireless force plate used for assessment and training.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      An ICP program will be set up using the Tymo. The child uses their trunk movements in the ICP&#xD;
      in sitting during the intervention. The children will receive the intervention 4 times/week,&#xD;
      20 minutes/session for 6 weeks. All children will be assessed at the beginning, 3, 6 and 12&#xD;
      weeks post-intervention.&#xD;
&#xD;
      Main outcome measures:&#xD;
&#xD;
        -  Segmental Assessment on Trunk control&#xD;
&#xD;
        -  Pediatric Reach Test&#xD;
&#xD;
        -  Gross Motor Function Measure Item Set (GMFM IS)&#xD;
&#xD;
        -  2-minute walk test&#xD;
&#xD;
      Data analysis:&#xD;
&#xD;
      As a pilot study, 20 children will be recruited for this study. Independent t-test or Mann&#xD;
      Whitney U test will be used to compare the continuous and ordinal results between the&#xD;
      intervention and control groups.&#xD;
&#xD;
      Expected results:&#xD;
&#xD;
      The trunk control, balance and gross motor function of children with CP will be significantly&#xD;
      improved after the intervention.&#xD;
&#xD;
      Clinical significance and potential of the study:&#xD;
&#xD;
      This is clinical trial to examine the effectiveness of a new intervention, a kind of&#xD;
      interactive computer play training module, on training the trunk control for children with&#xD;
      cerebral palsy. If the intervention is proven effective, it may be an adjunct to the&#xD;
      conventional Physiotherapy to children with movement disorders in enhancing their trunk&#xD;
      control. Better trunk control will in turn improve the daily function for these children as&#xD;
      their sitting and standing balance is improved. In a long run, these children will not rely&#xD;
      on expensive seating equipment to maintain their balance during schooling and at home.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cerebral palsy (CP) is the most common physical disabilities in childhood, affecting 2 to 2.5&#xD;
      per 1000 live-births worldwide and about 1.3 per 1000 live-births in Hong Kong. It is a&#xD;
      non-progressive lesion of the developing central nervous system affecting the control of&#xD;
      movements and postures in the children. Children with CP are usually classified using the&#xD;
      Gross Motor Function Classification System (GMFCS) according to age-specific gross motor&#xD;
      functional abilities and reliance on assistive devices (such as walking aids or wheeled&#xD;
      mobility). It is an ordinal grading system of five levels (I to V), in which self-initiated&#xD;
      movements, such as sitting, standing or walking, are described in relation to different age&#xD;
      groups. Children of levels I and II can generally walk without aids while children of level&#xD;
      III can walk with aids for short distances but usually choose wheeled mobility in community&#xD;
      settings. Children at level IV have limited motor ability in assisted standing, stepping, and&#xD;
      transfers. Children classified as level V are completely dependent for transportation in a&#xD;
      wheelchair and lack antigravity postural control. Numerous studies have shown that children&#xD;
      with CP, regardless their GMFCS levels, demonstrate problems in their postural control in&#xD;
      sitting and standing, which in turn affect their function and participation in daily life.&#xD;
      The main deficits in postural control in sitting for children with CP are lack of ability to&#xD;
      recruit direction-specific muscles in more severe children (GMFCS levels IV and V) or&#xD;
      inability to fine-tune the degree of muscle contraction according to specific situations.&#xD;
      Excessive contraction of antagonists is a common compensatory strategy. These ineffective&#xD;
      strategies to compensate their balance in sitting or standing positions will affect the&#xD;
      children's daily function such as desk work at school, transfers and ambulation.&#xD;
&#xD;
      Postural control involves controlling the body's position in space for stability and&#xD;
      motility. Good postural control around the trunk or 'trunk control' in short, allows an&#xD;
      individual to perform different tasks in an upright and vertical posture without losing the&#xD;
      balance. The control of trunk to maintain balance in either sitting or standing positions is&#xD;
      usually tested in the following three conditions: static balance, anticipatory balance and&#xD;
      reactive balance. Assessment of trunk control in children is commonly part of a motor&#xD;
      assessment such as Bruininks-Osteretsky Test of Motor Proficiency. The main limitation of&#xD;
      these motor assessments is that the trunk is considered a one unit during a motor act,&#xD;
      despite that there are different segments in the spine. Preliminary findings in very young&#xD;
      infants have shown that infants with lumbar control had better movement quality in reaching&#xD;
      actions when compared to those with thoracic control only. It seems that specific outcome&#xD;
      measures on trunk control are necessary to demonstrate improvement in movement quality like&#xD;
      this. There are specific outcome measures assessing balance, an indication of trunk control&#xD;
      in recovering stability after internal or external perturbations such as Pediatric Reach Test&#xD;
      (PRT), Pediatric Balance Scale, and Segmental Assessment on Trunk control (SATCo). It has&#xD;
      been found very few of the commonly used outcome measures on balance have covered assessing&#xD;
      all three aspects of balance as mentioned above. Most of these outcome measures require the&#xD;
      children to be able to sit independently with or without hand support, making it unsuitable&#xD;
      for children with CP of GMFCS levels IV and V. Furthermore, most of these outcome measures&#xD;
      have the same limitation in considering the trunk as one whole unit, not consisting of&#xD;
      different regions. Among all the commonly used assessment of trunk control, SATCo is a&#xD;
      recently refined assessment on segmental trunk control in children. The child's trunk control&#xD;
      is examined by progressively reducing the trunk support from the shoulder girdle to the&#xD;
      pelvis in order to assess the head control, upper thoracic, mid-thoracic, lower thoracic,&#xD;
      upper lumbar, lower lumbar and full trunk control. The trunk control is tested under 3&#xD;
      different conditions in sitting: to maintain the posture (static control), during voluntary&#xD;
      head movements (active control) and recovery of trunk control after a disturbance of balance&#xD;
      by a nudge (reactive control). (Butler et al, 2010) The preliminary results of the SATCo&#xD;
      showed a high inter-rater reliability (ICC ≥ 0.8) and moderate to good correlations with&#xD;
      other established motor assessments (r from 0.65 to 0.88). Besides assessing the trunk in&#xD;
      different segments, SATCO is one of the rare ones being able to assess reactive balance. It&#xD;
      has been recommended that to increase the comprehensiveness in assessing the balance&#xD;
      mechanism in children with CP, researchers can use the SATCo in combination of outcome&#xD;
      measures assessing more dynamic sitting balance, such as the PRT.&#xD;
&#xD;
      Interactive computer play (ICP) has become popular in rehabilitation for people with motor&#xD;
      impairments, including children with CP. During an ICP, a child interacts and plays with&#xD;
      virtual objects in a computer-generated environment, through the use of a computer console or&#xD;
      platform and the software, allowing the child to control the games through certain body&#xD;
      movements. Because the computer games are fun and enjoyable, the child will repeat the&#xD;
      required body movements in numerous times so as to get a high score in the game without&#xD;
      losing the interest. These numerous repetitions (essentially mass practice) and feedback from&#xD;
      the game scores (knowledge of performance and results) are important in motor learning and&#xD;
      enhancing neuroplasticity. Hence, ICP may be a feasible way to improve trunk control in&#xD;
      children with CP, in addition to the conventional therapies. Up to date, there are six&#xD;
      published studies using ICP or virtual reality in improving balance in children with CP..&#xD;
      From these 6 published studies, promising though conflicting results were found whether ICP&#xD;
      is effective in improving trunk control in children with CP. The main limitations of these&#xD;
      studies are the overall low levels of study quality, small sample sizes and heterogeneous&#xD;
      population groups under the umbrella term CP. In fact, similar conclusions for future studies&#xD;
      with larger sample sizes and rigorous study designs have been echoed from the four recent&#xD;
      systematic reviews on the topic.&#xD;
&#xD;
      One of possible reasons for the conflicting conclusion on the use of ICP in rehabilitation&#xD;
      for children with CP may be lack of sensitive outcome measures to capture the specific&#xD;
      changes in the trunk control post-intervention. The above-mentioned studies were either using&#xD;
      general motor assessments or outcome measures with unknown psychometric properties to assess&#xD;
      the posture of the participants. Besides, when the child received the ICP intervention in a&#xD;
      standing position, compensatory strategies, due to uncontrolled degrees of freedom in lower&#xD;
      limbs, might be used to maintain their trunk control in this more challenging position than a&#xD;
      sitting position. These compensatory strategies may in turn, water down the overall effect of&#xD;
      the ICP intervention on the trunk control. Most of these studies examined only one or two&#xD;
      aspect of the trunk control as testing the static or anticipatory balance of the children.&#xD;
      The commercial gaming consoles, such as Nintendo Wii Fit, are not specifically developed for&#xD;
      children with CP to elicit targeted movements to overcome their impairment and the software&#xD;
      may not be sensitive enough to translate the subtle movement changes to an increase in the&#xD;
      game scores as well to an adequate challenge for these children.&#xD;
&#xD;
      Tymo (Tyromotion, Austria, www.tyromotion.com) is a wireless force plate detecting the&#xD;
      movement of the centre of pressure, either in a sitting or standing position. Force and&#xD;
      weight distribution can be measured using the software provided with the Tymo in these two&#xD;
      positions. During the assessment, the user will move the trunk forward, backward and sideways&#xD;
      as far as they can. The amplitude of the force and weight distribution between the two sides&#xD;
      of the body will be recorded. This information will be used when the user uses the Tymo as a&#xD;
      balance training module, in which the user will move the trunk forward, backward and sideways&#xD;
      to participate in a computer game. For example, the user will move their trunk in different&#xD;
      directions so as to manoeuvre a basket to catch the falling apples. The difficulties of the&#xD;
      game will be adjusted according to the information provided during the assessment so that the&#xD;
      user needs to move their body accordingly in different directions without losing their&#xD;
      balance. This equipment is specially designed for rehabilitation for people with movement&#xD;
      disorders, hence unlike the commercial games, there are no flashing lights or sudden noises&#xD;
      during the games.&#xD;
&#xD;
      20 children with CP or similar physical disabilities will be recruited from 2 special schools&#xD;
      for children with physical disabilities in Hong Kong. Informed consent will be sought from&#xD;
      the parents or guardians before the study will commence. After the initial assessment, all&#xD;
      study children will be randomly allocated into a control group or treatment group (10&#xD;
      children in each arm) using a 'draw card from the hat'. The randomization will be separately&#xD;
      done in each school. The children in the treatment group will receive training on their trunk&#xD;
      control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment&#xD;
      will last for 6 weeks. All study children will continue their usual therapies at school but&#xD;
      will be asked to stop playing any interactive computer play, which is designed to train&#xD;
      balance such as Nintendo Wii balance board, during the study period. As there is no strong&#xD;
      research evidence that commercial computer games are effective in improving the balance for&#xD;
      children with CP and this type of commercial computer play is not a routine training&#xD;
      exercises for balance at the schools, it is believed that discontinuing this type of&#xD;
      'training' for 6 weeks would not cause detrimental effect on the balance of the study&#xD;
      children.&#xD;
&#xD;
      All the assessment will be carried out by a blinded assessor, who is not aware of the group&#xD;
      allocation of the children. All the children will be assessed at the beginning, and 3, 6 and&#xD;
      12 weeks after the commencement of the intervention.&#xD;
&#xD;
      All children will be calibrated using the Tymo in a static sitting position in each treatment&#xD;
      session by the research staff and the amplitude of the force and weight distribution&#xD;
      generated by the child between the two sides of the body will be recorded. This information&#xD;
      will be used to set up the Tymo as a training module (the intervention) by the software, in&#xD;
      which the child will move the trunk forward, backward and sideways to participate in a&#xD;
      computer game in sitting. The child will choose which game they want in each treatment&#xD;
      session and they have to stay on the same game for at least 10 minutes before changing to&#xD;
      another game. The child will have a maximal choice of 2 computer games in each treatment&#xD;
      session. All children will start at a medium level of difficulty. Only if the child is unable&#xD;
      to score any point in 3 trials in a row, the difficulty level will be reduced to one level&#xD;
      down. Similarly, if the child scores full points in 3 trials in a row, the difficulty level&#xD;
      will be increased to one level up. The progression of the intervention will then be closely&#xD;
      monitored by the research staff. A logbook will be used for each child to record the level of&#xD;
      difficulty in each treatment session, the number of treatment sessions, duration of each&#xD;
      session and general comments on the child in each session during the intervention phase by a&#xD;
      research assistant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Segmental Assessment on Trunk Control-static</measure>
    <time_frame>12 weeks</time_frame>
    <description>assess the level of static segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Segmental Assessment on Trunk Control-active</measure>
    <time_frame>12 weeks</time_frame>
    <description>assess the level of active segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Segmental Assessment on Trunk Control-reactive</measure>
    <time_frame>12 weeks</time_frame>
    <description>assess the level of reactive segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pediatric Reach Test-forward Sitting</measure>
    <time_frame>12 weeks</time_frame>
    <description>assess how far the child can reach forward in sitting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Reach Test- Right Sitting</measure>
    <time_frame>12 weeks</time_frame>
    <description>assess how far the child can reach to his/her right in sitting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Reach Test- Left Sitting</measure>
    <time_frame>12 weeks</time_frame>
    <description>assess how far the child can reach to his/her left in sitting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Reach Test- Forward Standing</measure>
    <time_frame>12 weeks</time_frame>
    <description>assess how far the child can reach forward in standing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Reach Test- Right Standing</measure>
    <time_frame>12 weeks</time_frame>
    <description>assess how far the child can reach to his/her right in standing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pediatric Reach Test- Left Standing</measure>
    <time_frame>12 weeks</time_frame>
    <description>assess how far the child can reach to his/her left in standing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gross Motor Function Measure Item Set- Total Score</measure>
    <time_frame>12 weeks</time_frame>
    <description>assess the gross motor function using Gross Motor Function Measure Item Set.There are 4 Item Sets: Item Set 1 includes 15 test items (score ranged from 0 to 45), Item Set 2 including 29 items (score ranged from 0 to 87), Item Set 3 including 39 items (score ranged from 0 to 117) and Item Set 4 including 22 test items (score ranged from 0 to 66). Each participant will only be assessed with 1 Item Set based on their score on pre-defined decision items (Russell et al.Gross Motor Function Measure (GMFM-66 &amp; GMFM-88) User's manual 2nd Edition. 2013). Individual item scores of the Item Set are entered and a mathematical algorithm calculates an interval level total score ranged from 0 to 100) using the Gross Motor Ability Estimator (GMAE-2) Scoring Software (https://www.canchild.ca/en/resources/191-gross-motor-ability-estimator-gmae-2-scoring-software-for-the-gmfm). The higher scores mean higher abilities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2-minute Walk Test</measure>
    <time_frame>12 weeks</time_frame>
    <description>measure how far the study participant can walk in 2 minutes in metres</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>12 weeks</time_frame>
    <description>measure the height of study participants in centimetres</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>12 weeks</time_frame>
    <description>measure the body weight of study participants in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gross Motor Function Measure 88- Lying</measure>
    <time_frame>12 weeks</time_frame>
    <description>assess the gross motor function in lying and rolling using Gross Motor Function Measure 88-lying (score ranged from 0 to 51) where higher score means higher gross motor function in this position.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gross Motor Function Measure 88- Sitting</measure>
    <time_frame>12 weeks</time_frame>
    <description>assess the gross motor function inlsitting using Gross Motor Function Measure 88-sitting (score ranged from 0 to 60) where higher score means higher gross motor function in this position.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gross Motor Function Measure 88- Crawling and Kneeling</measure>
    <time_frame>12 weeks</time_frame>
    <description>assess the gross motor function in crawling position using Gross Motor Function Measure 88-crawling and kneeling (score ranged from 0 to 42) where higher score means higher gross motor function in this position.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gross Motor Function Measure 88- Standing</measure>
    <time_frame>12 weeks</time_frame>
    <description>assess the gross motor function in standing position using Gross Motor Function Measure 88-standing (score ranged from 0 to 39) where higher score means higher gross motor function in this position.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Cerebral Palsy</condition>
  <condition>Exercise Therapy</condition>
  <condition>Postural Balance</condition>
  <arm_group>
    <arm_group_label>Interactive computer play (ICP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Therapy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Children in the control group will continue their usual therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tymo</intervention_name>
    <description>All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
    <arm_group_label>Interactive computer play (ICP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children with a diagnosis of CP will be of GMFCS levels III to IV, who in general,&#xD;
             require walking aid (level III) during ambulation and with limited walking ability&#xD;
             (level IV).[4] Aiming to achieve a higher homogeneity of the recruited children, for&#xD;
             those with level III, only those requiring physical assistance to climb stairs will be&#xD;
             recruited and so it is believed that only those with lower motor ability, i.e. similar&#xD;
             to level IV, will be included.&#xD;
&#xD;
          2. Children, with non-CP physical disabilities, will have similar gross motor function as&#xD;
             in (1).&#xD;
&#xD;
          3. Aged from 6 to 12 years old and&#xD;
&#xD;
          4. Able to follow instructions to interact in simple computer games&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Children with epilepsy/ seizures that could be elicited by flashing lights or sudden loud&#xD;
        noises from computer screens&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tamis W Pin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hong Kong Polytechnic University</name>
      <address>
        <city>Hung Hom</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24. Erratum In: Dev Med Child Neurol. 2016 Mar;58(3):316.</citation>
    <PMID>23346889</PMID>
  </reference>
  <reference>
    <citation>Yam WK, Chan HS, Tsui KW, Yiu BP, Fong SS, Cheng CY, Chan CW; Working Group on Cerebral Palsy, Hong Kong Society of Child Neurology and Developmental Paediatrics. Prevalence study of cerebral palsy in Hong Kong children. Hong Kong Med J. 2006 Jun;12(3):180-4.</citation>
    <PMID>16760544</PMID>
  </reference>
  <reference>
    <citation>Mutch L, Alberman E, Hagberg B, Kodama K, Perat MV. Cerebral palsy epidemiology: where are we now and where are we going? Dev Med Child Neurol. 1992 Jun;34(6):547-51. doi: 10.1111/j.1469-8749.1992.tb11479.x. No abstract available.</citation>
    <PMID>1612216</PMID>
  </reference>
  <reference>
    <citation>Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.</citation>
    <PMID>9183258</PMID>
  </reference>
  <reference>
    <citation>Butler PB, Saavedra S, Sofranac M, Jarvis SE, Woollacott MH. Refinement, reliability, and validity of the segmental assessment of trunk control. Pediatr Phys Ther. 2010 Fall;22(3):246-57. doi: 10.1097/PEP.0b013e3181e69490.</citation>
    <PMID>20699770</PMID>
  </reference>
  <reference>
    <citation>Rachwani J, Santamaria V, Saavedra SL, Wood S, Porter F, Woollacott MH. Segmental trunk control acquisition and reaching in typically developing infants. Exp Brain Res. 2013 Jul;228(1):131-9. doi: 10.1007/s00221-013-3544-y. Epub 2013 May 17.</citation>
    <PMID>23681292</PMID>
  </reference>
  <reference>
    <citation>Banas BB, Gorgon EJ. Clinimetric properties of sitting balance measures for children with cerebral palsy: a systematic review. Phys Occup Ther Pediatr. 2014 Aug;34(3):313-34. doi: 10.3109/01942638.2014.881952. Epub 2014 Feb 3.</citation>
    <PMID>24490854</PMID>
  </reference>
  <reference>
    <citation>Fehlings D, Switzer L, Findlay B, Knights S. Interactive computer play as &quot;motor therapy&quot; for individuals with cerebral palsy. Semin Pediatr Neurol. 2013 Jun;20(2):127-38. doi: 10.1016/j.spen.2013.06.003.</citation>
    <PMID>23948687</PMID>
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    <citation>Sandlund M, McDonough S, Hager-Ross C. Interactive computer play in rehabilitation of children with sensorimotor disorders: a systematic review. Dev Med Child Neurol. 2009 Mar;51(3):173-9. doi: 10.1111/j.1469-8749.2008.03184.x. Epub 2009 Jan 26.</citation>
    <PMID>19191834</PMID>
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    <citation>Snider L, Majnemer A, Darsaklis V. Virtual reality as a therapeutic modality for children with cerebral palsy. Dev Neurorehabil. 2010;13(2):120-8. doi: 10.3109/17518420903357753.</citation>
    <PMID>20222773</PMID>
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    <citation>Deutsch JE, Borbely M, Filler J, Huhn K, Guarrera-Bowlby P. Use of a low-cost, commercially available gaming console (Wii) for rehabilitation of an adolescent with cerebral palsy. Phys Ther. 2008 Oct;88(10):1196-207. doi: 10.2522/ptj.20080062. Epub 2008 Aug 8.</citation>
    <PMID>18689607</PMID>
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    <PMID>23030836</PMID>
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    <citation>Ramstrand N, Lygnegard F. Can balance in children with cerebral palsy improve through use of an activity promoting computer game? Technol Health Care. 2012;20(6):501-10. doi: 10.3233/THC-2012-0696.</citation>
    <PMID>23187015</PMID>
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    <PMID>22317271</PMID>
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    <PMID>21967300</PMID>
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    <PMID>17057438</PMID>
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    <citation>Pin TW. Psychometric properties of 2-minute walk test: a systematic review. Arch Phys Med Rehabil. 2014 Sep;95(9):1759-75. doi: 10.1016/j.apmr.2014.03.034. Epub 2014 May 9.</citation>
    <PMID>24814460</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <results_first_submitted>January 31, 2019</results_first_submitted>
  <results_first_submitted_qc>August 5, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 7, 2019</results_first_posted>
  <last_update_submitted>August 5, 2019</last_update_submitted>
  <last_update_submitted_qc>August 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Dr Tamis Wai-mun PIN</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>cerebral palsy</keyword>
  <keyword>video games</keyword>
  <keyword>postural control</keyword>
  <keyword>balance</keyword>
  <keyword>children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT02975804/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Children in the control group will continue their usual therapy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>the analysis population was not different from the assignment in the Participant Flow.</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Children in the control group will continue their usual therapy.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.92" spread="2.25"/>
                    <measurement group_id="B2" value="9.59" spread="1.87"/>
                    <measurement group_id="B3" value="9.26" spread="2.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hong Kong</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Segmental Assessment on Trunk Control-static</title>
        <description>assess the level of static segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Segmental Assessment on Trunk Control-static</title>
          <description>assess the level of static segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="7" upper_limit="8"/>
                    <measurement group_id="O2" value="8" lower_limit="5" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Segmental Assessment on Trunk Control-active</title>
        <description>assess the level of active segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Segmental Assessment on Trunk Control-active</title>
          <description>assess the level of active segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="5" upper_limit="8"/>
                    <measurement group_id="O2" value="8" lower_limit="4" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Segmental Assessment on Trunk Control-reactive</title>
        <description>assess the level of reactive segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Segmental Assessment on Trunk Control-reactive</title>
          <description>assess the level of reactive segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="4" upper_limit="8"/>
                    <measurement group_id="O2" value="6" lower_limit="1" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pediatric Reach Test-forward Sitting</title>
        <description>assess how far the child can reach forward in sitting</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Pediatric Reach Test-forward Sitting</title>
          <description>assess how far the child can reach forward in sitting</description>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.28" spread="74.5"/>
                    <measurement group_id="O2" value="10.72" spread="96.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pediatric Reach Test- Right Sitting</title>
        <description>assess how far the child can reach to his/her right in sitting</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Pediatric Reach Test- Right Sitting</title>
          <description>assess how far the child can reach to his/her right in sitting</description>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" spread="76.5"/>
                    <measurement group_id="O2" value="10.5" spread="94.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pediatric Reach Test- Left Sitting</title>
        <description>assess how far the child can reach to his/her left in sitting</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Pediatric Reach Test- Left Sitting</title>
          <description>assess how far the child can reach to his/her left in sitting</description>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.94" spread="80.50"/>
                    <measurement group_id="O2" value="10.06" spread="90.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pediatric Reach Test- Forward Standing</title>
        <description>assess how far the child can reach forward in standing</description>
        <time_frame>12 weeks</time_frame>
        <population>This outcome measure was abandoned as all the participants were unable to stand unaided long enough to complete the measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Pediatric Reach Test- Forward Standing</title>
          <description>assess how far the child can reach forward in standing</description>
          <population>This outcome measure was abandoned as all the participants were unable to stand unaided long enough to complete the measurement.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pediatric Reach Test- Right Standing</title>
        <description>assess how far the child can reach to his/her right in standing</description>
        <time_frame>12 weeks</time_frame>
        <population>This outcome measure was abandoned as all the participants were unable to stand unaided long enough to complete the measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Pediatric Reach Test- Right Standing</title>
          <description>assess how far the child can reach to his/her right in standing</description>
          <population>This outcome measure was abandoned as all the participants were unable to stand unaided long enough to complete the measurement.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pediatric Reach Test- Left Standing</title>
        <description>assess how far the child can reach to his/her left in standing</description>
        <time_frame>12 weeks</time_frame>
        <population>This outcome measure was abandoned as all the participants were unable to stand unaided long enough to complete the measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Pediatric Reach Test- Left Standing</title>
          <description>assess how far the child can reach to his/her left in standing</description>
          <population>This outcome measure was abandoned as all the participants were unable to stand unaided long enough to complete the measurement.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Gross Motor Function Measure Item Set- Total Score</title>
        <description>assess the gross motor function using Gross Motor Function Measure Item Set.There are 4 Item Sets: Item Set 1 includes 15 test items (score ranged from 0 to 45), Item Set 2 including 29 items (score ranged from 0 to 87), Item Set 3 including 39 items (score ranged from 0 to 117) and Item Set 4 including 22 test items (score ranged from 0 to 66). Each participant will only be assessed with 1 Item Set based on their score on pre-defined decision items (Russell et al.Gross Motor Function Measure (GMFM-66 &amp; GMFM-88) User's manual 2nd Edition. 2013). Individual item scores of the Item Set are entered and a mathematical algorithm calculates an interval level total score ranged from 0 to 100) using the Gross Motor Ability Estimator (GMAE-2) Scoring Software (https://www.canchild.ca/en/resources/191-gross-motor-ability-estimator-gmae-2-scoring-software-for-the-gmfm). The higher scores mean higher abilities.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Gross Motor Function Measure Item Set- Total Score</title>
          <description>assess the gross motor function using Gross Motor Function Measure Item Set.There are 4 Item Sets: Item Set 1 includes 15 test items (score ranged from 0 to 45), Item Set 2 including 29 items (score ranged from 0 to 87), Item Set 3 including 39 items (score ranged from 0 to 117) and Item Set 4 including 22 test items (score ranged from 0 to 66). Each participant will only be assessed with 1 Item Set based on their score on pre-defined decision items (Russell et al.Gross Motor Function Measure (GMFM-66 &amp; GMFM-88) User's manual 2nd Edition. 2013). Individual item scores of the Item Set are entered and a mathematical algorithm calculates an interval level total score ranged from 0 to 100) using the Gross Motor Ability Estimator (GMAE-2) Scoring Software (https://www.canchild.ca/en/resources/191-gross-motor-ability-estimator-gmae-2-scoring-software-for-the-gmfm). The higher scores mean higher abilities.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.06" spread="81.5"/>
                    <measurement group_id="O2" value="9.94" spread="89.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>2-minute Walk Test</title>
        <description>measure how far the study participant can walk in 2 minutes in metres</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>2-minute Walk Test</title>
          <description>measure how far the study participant can walk in 2 minutes in metres</description>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.11" spread="73.0"/>
                    <measurement group_id="O2" value="10.89" spread="98.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Height</title>
        <description>measure the height of study participants in centimetres</description>
        <time_frame>12 weeks</time_frame>
        <population>Data was not collected in the study as it was determined that measurement of height was not related to any of the primary outcomes. To cut down this outcome measure could also reduce the unnecessary measurement burden on the study participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Height</title>
          <description>measure the height of study participants in centimetres</description>
          <population>Data was not collected in the study as it was determined that measurement of height was not related to any of the primary outcomes. To cut down this outcome measure could also reduce the unnecessary measurement burden on the study participants.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weight</title>
        <description>measure the body weight of study participants in kilograms</description>
        <time_frame>12 weeks</time_frame>
        <population>Data was not collected in the study as it was determined that measurement of weight was not related to any of the primary outcomes. To cut down this outcome measure could also reduce the unnecessary measurement burden on the study participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Weight</title>
          <description>measure the body weight of study participants in kilograms</description>
          <population>Data was not collected in the study as it was determined that measurement of weight was not related to any of the primary outcomes. To cut down this outcome measure could also reduce the unnecessary measurement burden on the study participants.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Gross Motor Function Measure 88- Lying</title>
        <description>assess the gross motor function in lying and rolling using Gross Motor Function Measure 88-lying (score ranged from 0 to 51) where higher score means higher gross motor function in this position.</description>
        <time_frame>12 weeks</time_frame>
        <population>This outcome has been abandoned as it was decided to use a concise version of Gross Motor Function Measure Item Set to avoid over-burdening of the study participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Gross Motor Function Measure 88- Lying</title>
          <description>assess the gross motor function in lying and rolling using Gross Motor Function Measure 88-lying (score ranged from 0 to 51) where higher score means higher gross motor function in this position.</description>
          <population>This outcome has been abandoned as it was decided to use a concise version of Gross Motor Function Measure Item Set to avoid over-burdening of the study participants.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Gross Motor Function Measure 88- Sitting</title>
        <description>assess the gross motor function inlsitting using Gross Motor Function Measure 88-sitting (score ranged from 0 to 60) where higher score means higher gross motor function in this position.</description>
        <time_frame>12 weeks</time_frame>
        <population>This outcome has been abandoned as it was decided to use a concise version of Gross Motor Function Measure Item Set to avoid over-burdening of the study participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Gross Motor Function Measure 88- Sitting</title>
          <description>assess the gross motor function inlsitting using Gross Motor Function Measure 88-sitting (score ranged from 0 to 60) where higher score means higher gross motor function in this position.</description>
          <population>This outcome has been abandoned as it was decided to use a concise version of Gross Motor Function Measure Item Set to avoid over-burdening of the study participants.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Gross Motor Function Measure 88- Crawling and Kneeling</title>
        <description>assess the gross motor function in crawling position using Gross Motor Function Measure 88-crawling and kneeling (score ranged from 0 to 42) where higher score means higher gross motor function in this position.</description>
        <time_frame>12 weeks</time_frame>
        <population>This outcome has been abandoned as it was decided to use a concise version of Gross Motor Function Measure Item Set to avoid over-burdening of the study participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Gross Motor Function Measure 88- Crawling and Kneeling</title>
          <description>assess the gross motor function in crawling position using Gross Motor Function Measure 88-crawling and kneeling (score ranged from 0 to 42) where higher score means higher gross motor function in this position.</description>
          <population>This outcome has been abandoned as it was decided to use a concise version of Gross Motor Function Measure Item Set to avoid over-burdening of the study participants.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Gross Motor Function Measure 88- Standing</title>
        <description>assess the gross motor function in standing position using Gross Motor Function Measure 88-standing (score ranged from 0 to 39) where higher score means higher gross motor function in this position.</description>
        <time_frame>12 weeks</time_frame>
        <population>This outcome has been abandoned as it was decided to use a concise version of Gross Motor Function Measure Item Set to avoid over-burdening of the study participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Children in the control group will continue their usual therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Gross Motor Function Measure 88- Standing</title>
          <description>assess the gross motor function in standing position using Gross Motor Function Measure 88-standing (score ranged from 0 to 39) where higher score means higher gross motor function in this position.</description>
          <population>This outcome has been abandoned as it was decided to use a concise version of Gross Motor Function Measure Item Set to avoid over-burdening of the study participants.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.&#xD;
Tymo: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Children in the control group will continue their usual therapy.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Children should have a reasonable level of cognitive function to participate in the interactive computer play. Cognitive impairment is a common co-morbidities.&#xD;
Small sample size&#xD;
Increase type 1 error as repeated measurements on participants</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr tamis W Pin</name_or_title>
      <organization>The Hong Kong Polytechnic University</organization>
      <phone>85227666751</phone>
      <email>tamis.pin@polyu.edu.hk</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02975804
org study id: 14150171
nct id: NCT02975804
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objectives:

      This proposal is to investigate the effect of a 6-week training programme using an
      Interactive computer play (ICP) on the trunk control, balance and gross motor function in
      children with cerebral palsy (CP).

      Hypothesis to be tested:

      The trunk control, balance and gross motor function of children with CP will be significantly
      improved after the ICP programme.

      Design and subjects:

      20 children (6 to 12 years old) with CP will be recruited in this pilot randomised controlled
      trial. The children will be randomly allocated into a control or treatment group (10 children
      in each arm).

      Study instruments:

      Tymo is a wireless force plate used for assessment and training.

      Intervention:

      An ICP program will be set up using the Tymo. The child uses their trunk movements in the ICP
      in sitting during the intervention. The children will receive the intervention 4 times/week,
      20 minutes/session for 6 weeks. All children will be assessed at the beginning, 3, 6 and 12
      weeks post-intervention.

      Main outcome measures:

        -  Segmental Assessment on Trunk control

        -  Pediatric Reach Test

        -  Gross Motor Function Measure Item Set (GMFM IS)

        -  2-minute walk test

      Data analysis:

      As a pilot study, 20 children will be recruited for this study. Independent t-test or Mann
      Whitney U test will be used to compare the continuous and ordinal results between the
      intervention and control groups.

      Expected results:

      The trunk control, balance and gross motor function of children with CP will be significantly
      improved after the intervention.

      Clinical significance and potential of the study:

      This is clinical trial to examine the effectiveness of a new intervention, a kind of
      interactive computer play training module, on training the trunk control for children with
      cerebral palsy. If the intervention is proven effective, it may be an adjunct to the
      conventional Physiotherapy to children with movement disorders in enhancing their trunk
      control. Better trunk control will in turn improve the daily function for these children as
      their sitting and standing balance is improved. In a long run, these children will not rely
      on expensive seating equipment to maintain their balance during schooling and at home.
Cerebral palsy (CP) is the most common physical disabilities in childhood, affecting 2 to 2.5
      per 1000 live-births worldwide and about 1.3 per 1000 live-births in Hong Kong. It is a
      non-progressive lesion of the developing central nervous system affecting the control of
      movements and postures in the children. Children with CP are usually classified using the
      Gross Motor Function Classification System (GMFCS) according to age-specific gross motor
      functional abilities and reliance on assistive devices (such as walking aids or wheeled
      mobility). It is an ordinal grading system of five levels (I to V), in which self-initiated
      movements, such as sitting, standing or walking, are described in relation to different age
      groups. Children of levels I and II can generally walk without aids while children of level
      III can walk with aids for short distances but usually choose wheeled mobility in community
      settings. Children at level IV have limited motor ability in assisted standing, stepping, and
      transfers. Children classified as level V are completely dependent for transportation in a
      wheelchair and lack antigravity postural control. Numerous studies have shown that children
      with CP, regardless their GMFCS levels, demonstrate problems in their postural control in
      sitting and standing, which in turn affect their function and participation in daily life.
      The main deficits in postural control in sitting for children with CP are lack of ability to
      recruit direction-specific muscles in more severe children (GMFCS levels IV and V) or
      inability to fine-tune the degree of muscle contraction according to specific situations.
      Excessive contraction of antagonists is a common compensatory strategy. These ineffective
      strategies to compensate their balance in sitting or standing positions will affect the
      children's daily function such as desk work at school, transfers and ambulation.

      Postural control involves controlling the body's position in space for stability and
      motility. Good postural control around the trunk or 'trunk control' in short, allows an
      individual to perform different tasks in an upright and vertical posture without losing the
      balance. The control of trunk to maintain balance in either sitting or standing positions is
      usually tested in the following three conditions: static balance, anticipatory balance and
      reactive balance. Assessment of trunk control in children is commonly part of a motor
      assessment such as Bruininks-Osteretsky Test of Motor Proficiency. The main limitation of
      these motor assessments is that the trunk is considered a one unit during a motor act,
      despite that there are different segments in the spine. Preliminary findings in very young
      infants have shown that infants with lumbar control had better movement quality in reaching
      actions when compared to those with thoracic control only. It seems that specific outcome
      measures on trunk control are necessary to demonstrate improvement in movement quality like
      this. There are specific outcome measures assessing balance, an indication of trunk control
      in recovering stability after internal or external perturbations such as Pediatric Reach Test
      (PRT), Pediatric Balance Scale, and Segmental Assessment on Trunk control (SATCo). It has
      been found very few of the commonly used outcome measures on balance have covered assessing
      all three aspects of balance as mentioned above. Most of these outcome measures require the
      children to be able to sit independently with or without hand support, making it unsuitable
      for children with CP of GMFCS levels IV and V. Furthermore, most of these outcome measures
      have the same limitation in considering the trunk as one whole unit, not consisting of
      different regions. Among all the commonly used assessment of trunk control, SATCo is a
      recently refined assessment on segmental trunk control in children. The child's trunk control
      is examined by progressively reducing the trunk support from the shoulder girdle to the
      pelvis in order to assess the head control, upper thoracic, mid-thoracic, lower thoracic,
      upper lumbar, lower lumbar and full trunk control. The trunk control is tested under 3
      different conditions in sitting: to maintain the posture (static control), during voluntary
      head movements (active control) and recovery of trunk control after a disturbance of balance
      by a nudge (reactive control). (Butler et al, 2010) The preliminary results of the SATCo
      showed a high inter-rater reliability (ICC ≥ 0.8) and moderate to good correlations with
      other established motor assessments (r from 0.65 to 0.88). Besides assessing the trunk in
      different segments, SATCO is one of the rare ones being able to assess reactive balance. It
      has been recommended that to increase the comprehensiveness in assessing the balance
      mechanism in children with CP, researchers can use the SATCo in combination of outcome
      measures assessing more dynamic sitting balance, such as the PRT.

      Interactive computer play (ICP) has become popular in rehabilitation for people with motor
      impairments, including children with CP. During an ICP, a child interacts and plays with
      virtual objects in a computer-generated environment, through the use of a computer console or
      platform and the software, allowing the child to control the games through certain body
      movements. Because the computer games are fun and enjoyable, the child will repeat the
      required body movements in numerous times so as to get a high score in the game without
      losing the interest. These numerous repetitions (essentially mass practice) and feedback from
      the game scores (knowledge of performance and results) are important in motor learning and
      enhancing neuroplasticity. Hence, ICP may be a feasible way to improve trunk control in
      children with CP, in addition to the conventional therapies. Up to date, there are six
      published studies using ICP or virtual reality in improving balance in children with CP..
      From these 6 published studies, promising though conflicting results were found whether ICP
      is effective in improving trunk control in children with CP. The main limitations of these
      studies are the overall low levels of study quality, small sample sizes and heterogeneous
      population groups under the umbrella term CP. In fact, similar conclusions for future studies
      with larger sample sizes and rigorous study designs have been echoed from the four recent
      systematic reviews on the topic.

      One of possible reasons for the conflicting conclusion on the use of ICP in rehabilitation
      for children with CP may be lack of sensitive outcome measures to capture the specific
      changes in the trunk control post-intervention. The above-mentioned studies were either using
      general motor assessments or outcome measures with unknown psychometric properties to assess
      the posture of the participants. Besides, when the child received the ICP intervention in a
      standing position, compensatory strategies, due to uncontrolled degrees of freedom in lower
      limbs, might be used to maintain their trunk control in this more challenging position than a
      sitting position. These compensatory strategies may in turn, water down the overall effect of
      the ICP intervention on the trunk control. Most of these studies examined only one or two
      aspect of the trunk control as testing the static or anticipatory balance of the children.
      The commercial gaming consoles, such as Nintendo Wii Fit, are not specifically developed for
      children with CP to elicit targeted movements to overcome their impairment and the software
      may not be sensitive enough to translate the subtle movement changes to an increase in the
      game scores as well to an adequate challenge for these children.

      Tymo (Tyromotion, Austria, www.tyromotion.com) is a wireless force plate detecting the
      movement of the centre of pressure, either in a sitting or standing position. Force and
      weight distribution can be measured using the software provided with the Tymo in these two
      positions. During the assessment, the user will move the trunk forward, backward and sideways
      as far as they can. The amplitude of the force and weight distribution between the two sides
      of the body will be recorded. This information will be used when the user uses the Tymo as a
      balance training module, in which the user will move the trunk forward, backward and sideways
      to participate in a computer game. For example, the user will move their trunk in different
      directions so as to manoeuvre a basket to catch the falling apples. The difficulties of the
      game will be adjusted according to the information provided during the assessment so that the
      user needs to move their body accordingly in different directions without losing their
      balance. This equipment is specially designed for rehabilitation for people with movement
      disorders, hence unlike the commercial games, there are no flashing lights or sudden noises
      during the games.

      20 children with CP or similar physical disabilities will be recruited from 2 special schools
      for children with physical disabilities in Hong Kong. Informed consent will be sought from
      the parents or guardians before the study will commence. After the initial assessment, all
      study children will be randomly allocated into a control group or treatment group (10
      children in each arm) using a 'draw card from the hat'. The randomization will be separately
      done in each school. The children in the treatment group will receive training on their trunk
      control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment
      will last for 6 weeks. All study children will continue their usual therapies at school but
      will be asked to stop playing any interactive computer play, which is designed to train
      balance such as Nintendo Wii balance board, during the study period. As there is no strong
      research evidence that commercial computer games are effective in improving the balance for
      children with CP and this type of commercial computer play is not a routine training
      exercises for balance at the schools, it is believed that discontinuing this type of
      'training' for 6 weeks would not cause detrimental effect on the balance of the study
      children.

      All the assessment will be carried out by a blinded assessor, who is not aware of the group
      allocation of the children. All the children will be assessed at the beginning, and 3, 6 and
      12 weeks after the commencement of the intervention.

      All children will be calibrated using the Tymo in a static sitting position in each treatment
      session by the research staff and the amplitude of the force and weight distribution
      generated by the child between the two sides of the body will be recorded. This information
      will be used to set up the Tymo as a training module (the intervention) by the software, in
      which the child will move the trunk forward, backward and sideways to participate in a
      computer game in sitting. The child will choose which game they want in each treatment
      session and they have to stay on the same game for at least 10 minutes before changing to
      another game. The child will have a maximal choice of 2 computer games in each treatment
      session. All children will start at a medium level of difficulty. Only if the child is unable
      to score any point in 3 trials in a row, the difficulty level will be reduced to one level
      down. Similarly, if the child scores full points in 3 trials in a row, the difficulty level
      will be increased to one level up. The progression of the intervention will then be closely
      monitored by the research staff. A logbook will be used for each child to record the level of
      difficulty in each treatment session, the number of treatment sessions, duration of each
      session and general comments on the child in each session during the intervention phase by a
      research assistant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Segmental Assessment on Trunk Control-static
time frame: 12 weeks
description: assess the level of static segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.
measure: Segmental Assessment on Trunk Control-active
time frame: 12 weeks
description: assess the level of active segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.
measure: Segmental Assessment on Trunk Control-reactive
time frame: 12 weeks
description: assess the level of reactive segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.
measure: Pediatric Reach Test-forward Sitting
time frame: 12 weeks
description: assess how far the child can reach forward in sitting
measure: Pediatric Reach Test- Right Sitting
time frame: 12 weeks
description: assess how far the child can reach to his/her right in sitting
measure: Pediatric Reach Test- Left Sitting
time frame: 12 weeks
description: assess how far the child can reach to his/her left in sitting
measure: Pediatric Reach Test- Forward Standing
time frame: 12 weeks
description: assess how far the child can reach forward in standing
measure: Pediatric Reach Test- Right Standing
time frame: 12 weeks
description: assess how far the child can reach to his/her right in standing
measure: Pediatric Reach Test- Left Standing
time frame: 12 weeks
description: assess how far the child can reach to his/her left in standing
measure: Gross Motor Function Measure Item Set- Total Score
time frame: 12 weeks
description: assess the gross motor function using Gross Motor Function Measure Item Set.There are 4 Item Sets: Item Set 1 includes 15 test items (score ranged from 0 to 45), Item Set 2 including 29 items (score ranged from 0 to 87), Item Set 3 including 39 items (score ranged from 0 to 117) and Item Set 4 including 22 test items (score ranged from 0 to 66). Each participant will only be assessed with 1 Item Set based on their score on pre-defined decision items (Russell et al.Gross Motor Function Measure (GMFM-66 & GMFM-88) User's manual 2nd Edition. 2013). Individual item scores of the Item Set are entered and a mathematical algorithm calculates an interval level total score ranged from 0 to 100) using the Gross Motor Ability Estimator (GMAE-2) Scoring Software (https://www.canchild.ca/en/resources/191-gross-motor-ability-estimator-gmae-2-scoring-software-for-the-gmfm). The higher scores mean higher abilities.
measure: 2-minute Walk Test
time frame: 12 weeks
description: measure how far the study participant can walk in 2 minutes in metres
measure: Height
time frame: 12 weeks
description: measure the height of study participants in centimetres
measure: Weight
time frame: 12 weeks
description: measure the body weight of study participants in kilograms
measure: Gross Motor Function Measure 88- Lying
time frame: 12 weeks
description: assess the gross motor function in lying and rolling using Gross Motor Function Measure 88-lying (score ranged from 0 to 51) where higher score means higher gross motor function in this position.
measure: Gross Motor Function Measure 88- Sitting
time frame: 12 weeks
description: assess the gross motor function inlsitting using Gross Motor Function Measure 88-sitting (score ranged from 0 to 60) where higher score means higher gross motor function in this position.
measure: Gross Motor Function Measure 88- Crawling and Kneeling
time frame: 12 weeks
description: assess the gross motor function in crawling position using Gross Motor Function Measure 88-crawling and kneeling (score ranged from 0 to 42) where higher score means higher gross motor function in this position.
measure: Gross Motor Function Measure 88- Standing
time frame: 12 weeks
description: assess the gross motor function in standing position using Gross Motor Function Measure 88-standing (score ranged from 0 to 39) where higher score means higher gross motor function in this position.
arm group label: Interactive computer play (ICP)
arm group type: Experimental
description: The children in the treatment group will receive training on their trunk control using the Tymo in sitting 4 times per week for 20 minutes per session. The treatment will last for 6 weeks. All study children will continue their usual therapies at school.
arm group label: Standard Therapy
arm group type: No Intervention
description: Children in the control group will continue their usual therapy.
intervention type: Device
intervention name: Tymo
description: All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.
arm group label: Interactive computer play (ICP)
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Tamis W Pin, PhD
role: Principal Investigator
affiliation: Hong Kong Polytechnic University
facility: 
country: Hong Kong
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citation: Bartlett D, Birmingham T. Validity and reliability of a pediatric reach test. Pediatr Phys Ther. 2003 Summer;15(2):84-92. doi: 10.1097/01.PEP.0000067885.63909.5C.
PMID: 17057438
citation: Pin TW. Psychometric properties of 2-minute walk test: a systematic review. Arch Phys Med Rehabil. 2014 Sep;95(9):1759-75. doi: 10.1016/j.apmr.2014.03.034. Epub 2014 May 9.
PMID: 24814460
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Dr Tamis Wai-mun PIN
investigator title: Assistant Professor
mesh term: Cerebral Palsy
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Children should have a reasonable level of cognitive function to participate in the interactive computer play. Cognitive impairment is a common co-morbidities.
Small sample size
Increase type 1 error as repeated measurements on participants
point of contact: 