<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/NCT04483388</url>
  </required_header>
  <id_info>
    <org_study_id>12649913.0.0000.5537</org_study_id>
    <nct_id>NCT04483388</nct_id>
  </id_info>
  <brief_title>Training With Virtual Reality in Upper Arm Reaching of Children With Cerebral Palsy</brief_title>
  <official_title>Training With Virtual Reality in Upper Arm Reaching of Children With Cerebral Palsy: Crossover Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio Grande do Norte</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio Grande do Norte</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study was to evaluate the effects of training with Virtual Reality in&#xD;
      the movement range of children with Cerebral Palsy spastic hemiparetic.The study protocol&#xD;
      consisted of two days of training and 1 revaluation. The training A (Nintendo Wii®) and B&#xD;
      (standard protocol) were randomized the children in AB and BA sequences, with one week&#xD;
      interval. Immediately kinematics pre and post-training was held and after a week no&#xD;
      significant changes were observed for the angular variables and space-time between groups.&#xD;
      The Virtual Reality used for intervention to improve upper arm function in children with&#xD;
      Cerebral Palsy is still a relatively new method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: The disability of upper limb function (MS) of children with Cerebral Palsy (CP)&#xD;
      spastic hemiparetic restricts their participation in social activities. Virtual reality (VR)&#xD;
      has shown promising results in functional recovery of this population, however, few studies&#xD;
      have evaluated its effectiveness in the reaching of motion of these children. Objective: To&#xD;
      assess the effects of training with VR in the movement range of children with CP spastic&#xD;
      hemiparetic. Materials and Methods: We conducted a randomized crossover trial, where the&#xD;
      sample consisted of 12 children diagnosed with CP hemiparetic, both genders, with a mean age&#xD;
      of 9.63 ± 2.3 years. The sample description was performed by assessing muscle tone, range of&#xD;
      motion, grip strength, functional performance and disability. Kinematic analysis of the upper&#xD;
      limb was performed by Qualisys Motion Capture System®. The study protocol consisted of two&#xD;
      days of training and 1 revaluation. The training A (Nintendo Wii®) and B (standard protocol)&#xD;
      were randomized the children in AB and BA sequences, with one week interval. Immediately&#xD;
      kinematics pre and post-training was held and after a week. Data were analyzed using SPSS&#xD;
      20.0 (Statistical Package for Social Science) assigning a 5% significance level. The&#xD;
      kinematic variables were analyzed by two-way ANOVA for repeated measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Kinematic upper arm evaluation of children with cerebral palsy</measure>
    <time_frame>4 months</time_frame>
    <description>We used a standardized 3D-analysis protocol to evaluate upper limb kinematic. The evaluation was divided into two stages: static collection and dynamics. In static collection, the patient was seated on a bench with feet on the floor, so that a 90 ° angle hip, knee and ankle joints. A table was positioned at a distance of 100% of the length of the affected upper arm and at the height of the xiphoid process and were used 19 mm reflective markers at the following points anatomical. In the dynamic evaluation, the participant continued to sit on the bench, with arms at the side of the torso, maintaining 90 ° elbow flexion and hand on the table was asked to touch a cube. All children started reach movement with the unaffected limb. Therefore, 15 reaches per child in each member in total and it was performed one minute intervals between attempts. The following variables: duration of movement, peak velocity and angular variation of shoulder and elbow.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Group AB</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>After randomization, 6 children composed the AB sequence were initially submitted to experimental training with virtual reality and after a week, a period considered washout, the conventional training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group BA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>After randomization 6 children composed the BA sequence were initially submitted to conventional training and after a week, a period considered washout, the experimental training with virtual reality.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training with Virtual Reality</intervention_name>
    <description>Computed virtual reality therapy was performed using the Nintendo Wii® console equipment. This system allows interaction with the player by means of a movement detection system and the representation of his avatar graphical representation of a user in virtual reality. It has a remote control with a wireless system, responsible for capturing the speed, direction , acceleration and deceleration of movement. The movements performed by the player are captured and reproduced on a screen via an infrared light sensor, positioned above the TV. The feedback given by the TV provides the movement itself observing opportunity in real time, generating positive reinforcement and facilitating training and improved task. The software used in this study was the Nintendo Wii Sports.</description>
    <arm_group_label>Group AB</arm_group_label>
    <arm_group_label>Group BA</arm_group_label>
    <other_name>Training A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Training</intervention_name>
    <description>It was done five types of exercises following to the protocol:&#xD;
Exercise 1 (shoulder abduction); Exercise 2 (external rotation of the shoulder); Exercise 3 (elbow extension); Exercise 4 (weight transfer in upper limbs: a sitting position); Exercise 5 (function: task-oriented training).</description>
    <arm_group_label>Group AB</arm_group_label>
    <arm_group_label>Group BA</arm_group_label>
    <other_name>Training B</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of cerebral palsy spastic hemiparesis;&#xD;
&#xD;
          -  Aged 6 to 12 years old;&#xD;
&#xD;
          -  Preserved cognition to understand instructions;&#xD;
&#xD;
          -  Present no significant auditory and visual deficits;&#xD;
&#xD;
          -  The affected upper limb classified in levels II and III Rating System Manual (MACS,&#xD;
             English Manual Abilities Classification System). The level II corresponds to children&#xD;
             who are able to handle the majority of objects with low quality and / or speed of&#xD;
             movement, while at level III are those that manipulate objects with difficulty and low&#xD;
             speed, requiring assistance organization of activity. Spasticity ranked among the&#xD;
             levels 0 and 3 of the Modified Scale Ashworth.It has not performed orthopedic&#xD;
             surgeries, or have made use of botulinum toxin for less than six months, not&#xD;
             presenting seizures, controlled medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of pain or discomfort during the course of the training;&#xD;
&#xD;
          -  Refusal to follow commands and instructions and discontinuity of interventions.&#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>Ana Raquel Lindquist, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal do Rio Grande do Norte</affiliation>
  </overall_official>
  <reference>
    <citation>Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Task Force on Childhood Motor Disorders. Classification and definition of disorders causing hypertonia in childhood. Pediatrics. 2003 Jan;111(1):e89-97. doi: 10.1542/peds.111.1.e89.</citation>
    <PMID>12509602</PMID>
  </reference>
  <reference>
    <citation>Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.</citation>
    <PMID>16108461</PMID>
  </reference>
  <reference>
    <citation>Siebes RC, Wijnroks L, Vermeer A. Qualitative analysis of therapeutic motor intervention programmes for children with cerebral palsy: an update. Dev Med Child Neurol. 2002 Sep;44(9):593-603. doi: 10.1017/s0012162201002638.</citation>
    <PMID>12227614</PMID>
  </reference>
  <reference>
    <citation>Coleman A, Weir KA, Ware RS, Boyd RN. Relationship between communication skills and gross motor function in preschool-aged children with cerebral palsy. Arch Phys Med Rehabil. 2013 Nov;94(11):2210-7. doi: 10.1016/j.apmr.2013.03.025. Epub 2013 Apr 11.</citation>
    <PMID>23583864</PMID>
  </reference>
  <results_reference>
    <citation>Wu WC, Hung JW, Tseng CY, Huang YC. Group constraint-induced movement therapy for children with hemiplegic cerebral palsy: a pilot study. Am J Occup Ther. 2013 Mar-Apr;67(2):201-8. doi: 10.5014/ajot.2013.004374.</citation>
    <PMID>23433275</PMID>
  </results_reference>
  <results_reference>
    <citation>Chen YP, Kang LJ, Chuang TY, Doong JL, Lee SJ, Tsai MW, Jeng SF, Sung WH. Use of virtual reality to improve upper-extremity control in children with cerebral palsy: a single-subject design. Phys Ther. 2007 Nov;87(11):1441-57. doi: 10.2522/ptj.20060062. Epub 2007 Sep 25.</citation>
    <PMID>17895352</PMID>
  </results_reference>
  <results_reference>
    <citation>Chiu HC, Ada L, Lee HM. Upper limb training using Wii Sports Resort for children with hemiplegic cerebral palsy: a randomized, single-blind trial. Clin Rehabil. 2014 Oct;28(10):1015-24. doi: 10.1177/0269215514533709. Epub 2014 May 21.</citation>
    <PMID>24849793</PMID>
  </results_reference>
  <results_reference>
    <citation>Chen YP, Lee SY, Howard AM. Effect of virtual reality on upper extremity function in children with cerebral palsy: a meta-analysis. Pediatr Phys Ther. 2014 Fall;26(3):289-300. doi: 10.1097/PEP.0000000000000046.</citation>
    <PMID>24819682</PMID>
  </results_reference>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>August 11, 2015</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio Grande do Norte</investigator_affiliation>
    <investigator_full_name>Natália Feitoza do Nascimento</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Cerebral Palsy</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Physiotherapy</keyword>
  <keyword>Virtual Reality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04483388
org study id: 12649913.0.0000.5537
nct id: NCT04483388
lead sponsor: 
has dmc: Yes
The objective of this study was to evaluate the effects of training with Virtual Reality in
      the movement range of children with Cerebral Palsy spastic hemiparetic.The study protocol
      consisted of two days of training and 1 revaluation. The training A (Nintendo Wii®) and B
      (standard protocol) were randomized the children in AB and BA sequences, with one week
      interval. Immediately kinematics pre and post-training was held and after a week no
      significant changes were observed for the angular variables and space-time between groups.
      The Virtual Reality used for intervention to improve upper arm function in children with
      Cerebral Palsy is still a relatively new method.
Introduction: The disability of upper limb function (MS) of children with Cerebral Palsy (CP)
      spastic hemiparetic restricts their participation in social activities. Virtual reality (VR)
      has shown promising results in functional recovery of this population, however, few studies
      have evaluated its effectiveness in the reaching of motion of these children. Objective: To
      assess the effects of training with VR in the movement range of children with CP spastic
      hemiparetic. Materials and Methods: We conducted a randomized crossover trial, where the
      sample consisted of 12 children diagnosed with CP hemiparetic, both genders, with a mean age
      of 9.63 ± 2.3 years. The sample description was performed by assessing muscle tone, range of
      motion, grip strength, functional performance and disability. Kinematic analysis of the upper
      limb was performed by Qualisys Motion Capture System®. The study protocol consisted of two
      days of training and 1 revaluation. The training A (Nintendo Wii®) and B (standard protocol)
      were randomized the children in AB and BA sequences, with one week interval. Immediately
      kinematics pre and post-training was held and after a week. Data were analyzed using SPSS
      20.0 (Statistical Package for Social Science) assigning a 5% significance level. The
      kinematic variables were analyzed by two-way ANOVA for repeated measures.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Kinematic upper arm evaluation of children with cerebral palsy
time frame: 4 months
description: We used a standardized 3D-analysis protocol to evaluate upper limb kinematic. The evaluation was divided into two stages: static collection and dynamics. In static collection, the patient was seated on a bench with feet on the floor, so that a 90 ° angle hip, knee and ankle joints. A table was positioned at a distance of 100% of the length of the affected upper arm and at the height of the xiphoid process and were used 19 mm reflective markers at the following points anatomical. In the dynamic evaluation, the participant continued to sit on the bench, with arms at the side of the torso, maintaining 90 ° elbow flexion and hand on the table was asked to touch a cube. All children started reach movement with the unaffected limb. Therefore, 15 reaches per child in each member in total and it was performed one minute intervals between attempts. The following variables: duration of movement, peak velocity and angular variation of shoulder and elbow.
arm group label: Group AB
arm group type: Other
description: After randomization, 6 children composed the AB sequence were initially submitted to experimental training with virtual reality and after a week, a period considered washout, the conventional training.
arm group label: Group BA
arm group type: Other
description: After randomization 6 children composed the BA sequence were initially submitted to conventional training and after a week, a period considered washout, the experimental training with virtual reality.
intervention type: Other
intervention name: Training with Virtual Reality
description: Computed virtual reality therapy was performed using the Nintendo Wii® console equipment. This system allows interaction with the player by means of a movement detection system and the representation of his avatar graphical representation of a user in virtual reality. It has a remote control with a wireless system, responsible for capturing the speed, direction , acceleration and deceleration of movement. The movements performed by the player are captured and reproduced on a screen via an infrared light sensor, positioned above the TV. The feedback given by the TV provides the movement itself observing opportunity in real time, generating positive reinforcement and facilitating training and improved task. The software used in this study was the Nintendo Wii Sports.
arm group label: Group AB
arm group label: Group BA
other name: Training A
intervention type: Other
intervention name: Conventional Training
description: It was done five types of exercises following to the protocol:
Exercise 1 (shoulder abduction); Exercise 2 (external rotation of the shoulder); Exercise 3 (elbow extension); Exercise 4 (weight transfer in upper limbs: a sitting position); Exercise 5 (function: task-oriented training).
arm group label: Group AB
arm group label: Group BA
other name: Training B
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Ana Raquel Lindquist, PhD
role: Principal Investigator
affiliation: Universidade Federal do Rio Grande do Norte
citation: Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Task Force on Childhood Motor Disorders. Classification and definition of disorders causing hypertonia in childhood. Pediatrics. 2003 Jan;111(1):e89-97. doi: 10.1542/peds.111.1.e89.
PMID: 12509602
citation: Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
PMID: 16108461
citation: Siebes RC, Wijnroks L, Vermeer A. Qualitative analysis of therapeutic motor intervention programmes for children with cerebral palsy: an update. Dev Med Child Neurol. 2002 Sep;44(9):593-603. doi: 10.1017/s0012162201002638.
PMID: 12227614
citation: Coleman A, Weir KA, Ware RS, Boyd RN. Relationship between communication skills and gross motor function in preschool-aged children with cerebral palsy. Arch Phys Med Rehabil. 2013 Nov;94(11):2210-7. doi: 10.1016/j.apmr.2013.03.025. Epub 2013 Apr 11.
PMID: 23583864
citation: Wu WC, Hung JW, Tseng CY, Huang YC. Group constraint-induced movement therapy for children with hemiplegic cerebral palsy: a pilot study. Am J Occup Ther. 2013 Mar-Apr;67(2):201-8. doi: 10.5014/ajot.2013.004374.
PMID: 23433275
citation: Chen YP, Kang LJ, Chuang TY, Doong JL, Lee SJ, Tsai MW, Jeng SF, Sung WH. Use of virtual reality to improve upper-extremity control in children with cerebral palsy: a single-subject design. Phys Ther. 2007 Nov;87(11):1441-57. doi: 10.2522/ptj.20060062. Epub 2007 Sep 25.
PMID: 17895352
citation: Chiu HC, Ada L, Lee HM. Upper limb training using Wii Sports Resort for children with hemiplegic cerebral palsy: a randomized, single-blind trial. Clin Rehabil. 2014 Oct;28(10):1015-24. doi: 10.1177/0269215514533709. Epub 2014 May 21.
PMID: 24849793
citation: Chen YP, Lee SY, Howard AM. Effect of virtual reality on upper extremity function in children with cerebral palsy: a meta-analysis. Pediatr Phys Ther. 2014 Fall;26(3):289-300. doi: 10.1097/PEP.0000000000000046.
PMID: 24819682
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio Grande do Norte
investigator full name: Natália Feitoza do Nascimento
investigator title: Clinical Professor
mesh term: Paralysis
mesh term: Cerebral Palsy