<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/NCT04403464</url>
  </required_header>
  <id_info>
    <org_study_id>B403201316810e</org_study_id>
    <nct_id>NCT04403464</nct_id>
  </id_info>
  <brief_title>Effect of a New Interactive Device on the Motor and Functional Abilities of Children With Bilateral Cerebral Palsy</brief_title>
  <official_title>The Effect of Using a New Interactive Device Based on Motor Skill Learning Principles on the Motor and Functional Abilities of Children With Bilateral Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Université Catholique de Louvain</source>
  <oversight_info>
    <has_dmc>No</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>
      Recent research has shown that interventions with assistive technologies lead to an&#xD;
      improvement in the motor and functional abilities of children with cerebral palsy (CP).&#xD;
      REAtouch® is a new interactive interface based on motor skill learning principles. Its&#xD;
      efficiency during intensive motor skill learning interventions has never been tested in&#xD;
      children with bilateral cerebral palsy.&#xD;
&#xD;
      Therefore, the study aims to investigate the efficiency of using a virtual reality tool to&#xD;
      provide a motor skill learning intervention in a randomized trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent research has shown that interventions with assistive technologies could lead to an&#xD;
      improvement in the motor and functional abilities of children with cerebral palsy (CP).&#xD;
      However they usually miss the functional motor skill learning qualities to match the changes&#xD;
      observed in high intensity motor skill learning based interventions.REAtouch® is a new&#xD;
      interactive interface based on motor skill learning principles that could be implemented in&#xD;
      intensive interventions.&#xD;
&#xD;
      Therefore, the study aims to investigate the effects of intensive interventions with or&#xD;
      without the interface on the motor and functional abilities of children with bilateral CP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 26, 2020</start_date>
  <completion_date type="Anticipated">December 20, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 20, 2022</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>Changes in Gross Motor Function Measure (GMFM-66):</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow- up</time_frame>
    <description>The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in ABILHAND-Kids Questionnaire</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow- up</time_frame>
    <description>This ABILHAND-Kids Questionnaire has been developed to assess a child's unimanual and bimanual upper limb activities. It ranges from - 6 to +6 logits (higher score means better performance).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Test of Arm Selective Control (TASC)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow- up</time_frame>
    <description>The TASC is an upper limb selective motor control evaluation tool including eight motions in each arm and up to three attempts are allowed for each motion. After completion of the best attempt, points ranging from 0 (absent), 1 (impaired) to 2 (normal) are recorded for each joint depending on the movement properties and descriptors of the test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Selective Control Assessment of the Lower Extremity (SCALE)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow- up</time_frame>
    <description>The SCALE was designed to evaluate lower limb selective motor control of children with cerebral palsy. The SCALE includes testing of five reciprocal lower extremity movements. SVMC is graded at each joint as 'Normal' (2 points), 'Impaired' (1 point), or 'Unable' (0 points).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in 6 Minutes Walking Test (6MWT)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow- up</time_frame>
    <description>The 6 Minutes Walking Test measures the distance that the patient walk as much as possible within a period of 6-minutes in a 30 meters long corridor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Box and Blocks test (BBT)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow- up</time_frame>
    <description>The BBT is a test of gross manual dexterity. Each hand is tested individually and the BBT is scored through the number of blocks carried over the partition from one part to another part of a box during the one-minute trial period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Jebsen-Taylor Test</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow- up</time_frame>
    <description>The Jebsen-Taylor Test assesses uni-manual hand function, through 7 subtests simulating daily life activities. The test assesses speed, not quality of performance and time to complete each activity is reported using a stopwatch.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Modified Cooper test</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow- up</time_frame>
    <description>The Modified Cooper test is a modified version of The Manual Form Perception Test, which evaluates stereognosis through 16 objects. Both hands are tested separately and time to recognise the objects is reported using a stopwatch.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in ACTIVLIM-CP Questionnaire</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow- up</time_frame>
    <description>The ACTIVLIM-CP Questionnaire measures a patient's ability to perform daily activities requiring the use of the upper and/or the lower limbs through 42 items specific to patients with cerebral palsy. It ranges from - 5 to +5 logits (higher score means better performance).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in ABILOCO-Kids Questionnaire</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow- up</time_frame>
    <description>The ABILOCO-Kids Questionnaire measures a patient's ability to perform daily activities requiring the use of the lower limbs through 10 items specific to patients with cerebral palsy. It ranges from - 4 to +4 logits (higher score means better performance).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow- up</time_frame>
    <description>The PEDI-CAT is the new version of the Pediatric Evaluation of Disability Inventory (PEDI). The PEDI-CAT is comprised of 276 functional activities acquired throughout infancy, childhood and young adulthood. Based on the nternational Classification of Functioning, Disability and Health for Children and Youth (ICF-CY) model, the PEDI-CAT contents provide information about the activities and participation component. It ranges from 0 to 100% (higher score means better performance).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Canadian Occupational Performance Measure (COPM)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow- up</time_frame>
    <description>The COPM measures the patient's self-perception of occupational performance and satisfaction of it in daily activities over time. It ranges from 1 to 10 (higher score means better performance).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Both Hands Assessment (BoHA)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow- up</time_frame>
    <description>The BoHA is a videotaped tool measuring how effectively children with bilateral CP use both hands in bimanual activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Executive Functions</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow-up</time_frame>
    <description>Cognitive functions of the children will be assessed by Stroop task and Flanker task.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in spatial parameters of the gait (Kinematics assessments)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow-up</time_frame>
    <description>Through a 3D motion system, we measure the stride length (meters), step length (meters) and step width (meters).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in temporal parameters of the gait (Cycle time)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow-up</time_frame>
    <description>Through a 3D motion system, we measure the cycle of gait time (seconds).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in temporal parameters of the gait (Stance time)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow-up</time_frame>
    <description>Through a 3D motion system, we measure the stance time (percentage of the total gait cycle).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in temporal parameters of the gait (Swing time)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow-up</time_frame>
    <description>Through a 3D motion system, we measure the swing time (percentage of the total gait cycle).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in temporal parameters of the gait (Stride)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow-up</time_frame>
    <description>Through a 3D motion system, we measure the gait cadence (stride per minute).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in temporal parameters of the gait (Velocity)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow-up</time_frame>
    <description>Through a 3D motion system, we measure the gait velocity (meter/second).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in temporal parameters of the gait (Acceleration)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow-up</time_frame>
    <description>Through a 3D motion system, we measure the gait acceleration (meters/second^2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in spatial parameters of the upper extremity (Straightness)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow-up</time_frame>
    <description>Through a 3D motion system, we measure the straightness (percentage of upper extremity trajectory during a reaching task).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in spatial parameters of the upper extremity (Smoothness)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow-up</time_frame>
    <description>Through a 3D motion system, we measure the smoothness (variability of the movement during a reaching task)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in temporal parameters of the upper extremity (Kinematics assessments)</measure>
    <time_frame>pre-camp (1 week before), post-camp (1 week after), 3 months follow-up</time_frame>
    <description>Through a 3D motion system, we measure the time from onset to end of the task (seconds). the task consists in a reaching task.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>HABIT-ILE with REAtouch®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hand and Arm Bimanual Intensive Therapy Including Lower Extremities with an interactive device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HABIT-ILE without REAtouch®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hand and Arm Bimanual Intensive Therapy Including Lower Extremities</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HABIT-ILE with REAtouch®</intervention_name>
    <description>65h HABIT-ILE including 30h REAtouch®</description>
    <arm_group_label>HABIT-ILE with REAtouch®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HABIT-ILE without REAtouch®</intervention_name>
    <description>65h HABIT-ILE</description>
    <arm_group_label>HABIT-ILE without REAtouch®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed bilateral cerebral palsy,&#xD;
&#xD;
          -  MACS levels from I to III,&#xD;
&#xD;
          -  GMFCS levels from I to III,&#xD;
&#xD;
          -  Ability to follow instructions and complete testing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Orthopedic surgery, botulinum toxin injections or another unusual intervention less&#xD;
             than 6 months before or within the study period.&#xD;
&#xD;
          -  Unstable seizure&#xD;
&#xD;
          -  Severe visual or cognitive impairments likely to interfere with intervention or&#xD;
             testing session completion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yannick Bleyenheuft, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Neuroscience, UCLouvain</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yannick Bleyenheuft, Professor</last_name>
    <phone>+32 2 764 93 49</phone>
    <email>yannick.bleyenheuft@uclouvain.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Seyma Kilcioglu, PhD Student</last_name>
    <email>seyma.kilcioglu@student.uclouvain.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institute of Neuroscience, UCLouvain</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yannick Bleyenheuft, PT, PhD</last_name>
      <email>yannick.bleyenheuft@uclouvain.be</email>
    </contact>
    <contact_backup>
      <last_name>Seyma Kilcioglu, PhD Student</last_name>
      <email>seyma.kilcioglu@student.uclouvain.be</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>June 14, 2022</last_update_submitted>
  <last_update_submitted_qc>June 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université Catholique de Louvain</investigator_affiliation>
    <investigator_full_name>Yannick Bleyenheuft</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>motor skill learning</keyword>
  <keyword>intensive therapy</keyword>
  <keyword>selective voluntary motor control</keyword>
  <keyword>cerebral palsy</keyword>
  <keyword>assistive technology</keyword>
  <keyword>therapeutic device</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04403464
org study id: B403201316810e
nct id: NCT04403464
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Recent research has shown that interventions with assistive technologies lead to an
      improvement in the motor and functional abilities of children with cerebral palsy (CP).
      REAtouch® is a new interactive interface based on motor skill learning principles. Its
      efficiency during intensive motor skill learning interventions has never been tested in
      children with bilateral cerebral palsy.

      Therefore, the study aims to investigate the efficiency of using a virtual reality tool to
      provide a motor skill learning intervention in a randomized trial.
Recent research has shown that interventions with assistive technologies could lead to an
      improvement in the motor and functional abilities of children with cerebral palsy (CP).
      However they usually miss the functional motor skill learning qualities to match the changes
      observed in high intensity motor skill learning based interventions.REAtouch® is a new
      interactive interface based on motor skill learning principles that could be implemented in
      intensive interventions.

      Therefore, the study aims to investigate the effects of intensive interventions with or
      without the interface on the motor and functional abilities of children with bilateral CP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes in Gross Motor Function Measure (GMFM-66):
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
description: The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy.
measure: Changes in ABILHAND-Kids Questionnaire
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
description: This ABILHAND-Kids Questionnaire has been developed to assess a child's unimanual and bimanual upper limb activities. It ranges from - 6 to +6 logits (higher score means better performance).
measure: Changes in Test of Arm Selective Control (TASC)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
description: The TASC is an upper limb selective motor control evaluation tool including eight motions in each arm and up to three attempts are allowed for each motion. After completion of the best attempt, points ranging from 0 (absent), 1 (impaired) to 2 (normal) are recorded for each joint depending on the movement properties and descriptors of the test.
measure: Changes in Selective Control Assessment of the Lower Extremity (SCALE)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
description: The SCALE was designed to evaluate lower limb selective motor control of children with cerebral palsy. The SCALE includes testing of five reciprocal lower extremity movements. SVMC is graded at each joint as 'Normal' (2 points), 'Impaired' (1 point), or 'Unable' (0 points).
measure: Changes in 6 Minutes Walking Test (6MWT)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
description: The 6 Minutes Walking Test measures the distance that the patient walk as much as possible within a period of 6-minutes in a 30 meters long corridor.
measure: Changes in Box and Blocks test (BBT)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
description: The BBT is a test of gross manual dexterity. Each hand is tested individually and the BBT is scored through the number of blocks carried over the partition from one part to another part of a box during the one-minute trial period.
measure: Changes in Jebsen-Taylor Test
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
description: The Jebsen-Taylor Test assesses uni-manual hand function, through 7 subtests simulating daily life activities. The test assesses speed, not quality of performance and time to complete each activity is reported using a stopwatch.
measure: Changes in Modified Cooper test
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
description: The Modified Cooper test is a modified version of The Manual Form Perception Test, which evaluates stereognosis through 16 objects. Both hands are tested separately and time to recognise the objects is reported using a stopwatch.
measure: Changes in ACTIVLIM-CP Questionnaire
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
description: The ACTIVLIM-CP Questionnaire measures a patient's ability to perform daily activities requiring the use of the upper and/or the lower limbs through 42 items specific to patients with cerebral palsy. It ranges from - 5 to +5 logits (higher score means better performance).
measure: Changes in ABILOCO-Kids Questionnaire
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
description: The ABILOCO-Kids Questionnaire measures a patient's ability to perform daily activities requiring the use of the lower limbs through 10 items specific to patients with cerebral palsy. It ranges from - 4 to +4 logits (higher score means better performance).
measure: Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
description: The PEDI-CAT is the new version of the Pediatric Evaluation of Disability Inventory (PEDI). The PEDI-CAT is comprised of 276 functional activities acquired throughout infancy, childhood and young adulthood. Based on the nternational Classification of Functioning, Disability and Health for Children and Youth (ICF-CY) model, the PEDI-CAT contents provide information about the activities and participation component. It ranges from 0 to 100% (higher score means better performance).
measure: Changes in Canadian Occupational Performance Measure (COPM)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
description: The COPM measures the patient's self-perception of occupational performance and satisfaction of it in daily activities over time. It ranges from 1 to 10 (higher score means better performance).
measure: Changes in Both Hands Assessment (BoHA)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow- up
description: The BoHA is a videotaped tool measuring how effectively children with bilateral CP use both hands in bimanual activities.
measure: Changes in Executive Functions
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
description: Cognitive functions of the children will be assessed by Stroop task and Flanker task.
measure: Changes in spatial parameters of the gait (Kinematics assessments)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
description: Through a 3D motion system, we measure the stride length (meters), step length (meters) and step width (meters).
measure: Changes in temporal parameters of the gait (Cycle time)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
description: Through a 3D motion system, we measure the cycle of gait time (seconds).
measure: Changes in temporal parameters of the gait (Stance time)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
description: Through a 3D motion system, we measure the stance time (percentage of the total gait cycle).
measure: Changes in temporal parameters of the gait (Swing time)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
description: Through a 3D motion system, we measure the swing time (percentage of the total gait cycle).
measure: Changes in temporal parameters of the gait (Stride)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
description: Through a 3D motion system, we measure the gait cadence (stride per minute).
measure: Changes in temporal parameters of the gait (Velocity)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
description: Through a 3D motion system, we measure the gait velocity (meter/second).
measure: Changes in temporal parameters of the gait (Acceleration)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
description: Through a 3D motion system, we measure the gait acceleration (meters/second^2).
measure: Changes in spatial parameters of the upper extremity (Straightness)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
description: Through a 3D motion system, we measure the straightness (percentage of upper extremity trajectory during a reaching task).
measure: Changes in spatial parameters of the upper extremity (Smoothness)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
description: Through a 3D motion system, we measure the smoothness (variability of the movement during a reaching task)
measure: Changes in temporal parameters of the upper extremity (Kinematics assessments)
time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
description: Through a 3D motion system, we measure the time from onset to end of the task (seconds). the task consists in a reaching task.
arm group label: HABIT-ILE with REAtouch®
arm group type: Experimental
description: Hand and Arm Bimanual Intensive Therapy Including Lower Extremities with an interactive device
arm group label: HABIT-ILE without REAtouch®
arm group type: Active Comparator
description: Hand and Arm Bimanual Intensive Therapy Including Lower Extremities
intervention type: Behavioral
intervention name: HABIT-ILE with REAtouch®
description: 65h HABIT-ILE including 30h REAtouch®
arm group label: HABIT-ILE with REAtouch®
intervention type: Behavioral
intervention name: HABIT-ILE without REAtouch®
description: 65h HABIT-ILE
arm group label: HABIT-ILE without REAtouch®
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: No
last name: Yannick Bleyenheuft, Professor
role: Principal Investigator
affiliation: Institute of Neuroscience, UCLouvain
last name: Yannick Bleyenheuft, Professor
phone: +32 2 764 93 49
email: yannick.bleyenheuft@uclouvain.be
last name: Seyma Kilcioglu, PhD Student
email: seyma.kilcioglu@student.uclouvain.be
facility: 
status: Recruiting
contact: 
contact backup: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Université Catholique de Louvain
investigator full name: Yannick Bleyenheuft
investigator title: Professor
mesh term: Paralysis
mesh term: Cerebral Palsy
sharing ipd: No