Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy

Study Overview
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Brief Summary
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The aims of the present study is to evaluate the effectiveness of Kinect-based upper limb motor rehabilitation system (ULMTS) program on motor performance and functional outcomes.

Detailed Description
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The specific aims of this study project will be: To compare the effectiveness of intervention groups using Kinect-based ULMTS with constraint-induced therapy on motor improvement in children with hemiplegic CP. The investigators hypothesize that motor improvement in using Kinect-based ULMTS will be comparable to constraint-induced therapy.

Official Title
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Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: Constraint-induced therapy
* Other: kinect-based constraint-induced therapy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria are: 3-16 years old diagnosed with congenital hemiplegic or CP with one more affected side considerable nonuse of the affected upper limb. Exclusion criteria are: no excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon & Smith, 1987) no severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation no injections of botulinum toxin type A or operations on the upper limb within 6 months.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: constraint-induced therapy<br>training of the more affected arm and restraint the less affected arm | Other: Constraint-induced therapy<br> <br> |
| Experimental: kinect-based constraint-induced therapy<br>training of the more affected arm and restraint the less affected arm by kinect-game | Other: kinect-based constraint-induced therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance Change assessed by Kinematic analysis | Kinematic analysis including measuring the parameters of endpoint control, joint recruitment and inter-joint coordination, and trunk involvement. | baseline, 2 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score change of Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2) |  | baseline, 1 months, 2 months and 6 months | 
| score change of Melbourne Assessment 2 (MA2) |  | baseline, 1 months, 2 months and 6 months | 
| score change of Pediatric Motor Activity Log-Revised (PMAL-R) |  | baseline, 1 months, 2 months and 6 months | 
| score change of ABILHAND-kids |  | baseline, 1 months, 2 months and 6 months | 
| score change of Functional Independence Measures for children (WeeFIM) |  | baseline, 1 months, 2 months and 6 months | 
| score change of Pediatric evaluation of disability inventory (PEDI) |  | baseline, 1 months, 2 months and 6 months | 
| score change of Cerebral Palsy Quality of Life Questionnaire for Children (CP-QOL) |  | baseline, 1 months, 2 months and 6 months | 
| score change of Test of Visual Perceptual Skills-3rd (TVPS-3) |  | baseline, 1 months, 2 months and 6 months | 
| score change of Test of Playfulness (TOP) |  | baseline, 1 months, 2 months and 6 months | 
| score change of Engagement Questionnaire (EQ) |  | baseline, 1 months, 2 months and 6 months | 
| score change of Clint Satisfaction Questionnaire (CSQ) |  | baseline, 1 months, 2 months and 6 months | 
| score change of Parenting Stress Index-Short Form (PSI-SF) |  | baseline, 1 months, 2 months and 6 months | 
| Muscle strength | measured by electromyography | baseline, 2 months and 6 months | 
| score change of Building Tower Test |  | baseline, 1 months, 2 months and 6 months | 
| score change of Test of String Beads |  | baseline, 1 months, 2 months and 6 months | 
| score change of Box and Block Test |  | baseline, 1 months, 2 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Palsy, Neurological Rehabilitation, Upper Extremity