Kinect Sensor in Cerebral Palsy Children Phase 2.2

Study Overview
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Brief Summary
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There are 3 phase of the study. This registration is phase 2.2. This registration will conduct a randomized controlled trial study in the cerebral palsy children. Due to the limitation of period of time of grant, we changed the study type into pilot-randomization. Our new method of study will collect all of our study which previously separated into pilot and randomized controlled trial in just only one study pilot-randomization.

Official Title
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The Engineer-built System, Video-game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children

Conditions
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Cerebral Palsy Children, Upper Extremity Problem

Intervention / Treatment
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* Device: The engineer-built system, video-game based Kinect sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spastic cerebral palsy aged 10-15 years Sufficient cognitive/attention capacity to understand basic instructions Can cooperate with the therapist for short period of time during training Manual Ability Classification System (MACS) 2-3 Zancolli classification of the affected upper extremity was grade I-II. Give the informed consent Exclusion Criteria: Inability to understand the instruction and follow the task Severe comorbidities, visual or auditory impairment Had history of Botulinum toxin injection on the affected upper extremity for last 6 months or receive the injection during the study time Other treatment options planned on the affected upper extremity during the study time Wear daytime orthosis on the affected limb Zancolli classification of the affected hand was grade III. Got an epilepsy or convulsive condition Denied to give the informed consent or continue the study

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 15 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: video game in CP children<br>Children in this arm will play the computer game which was developed by the researcher team 3 session/weeks for 5 weeks. Each session will last for 40 minutes. | Device: The engineer-built system, video-game based Kinect sensor<br>* The games were developed by the researcher team.<br>* Other names: conventional occupational therapy program;|
| No Intervention: Conventional therapy<br>children in this arm will receive a conventional program by occupational therapists 3 times/week for 5 weeks. Each session will last for 40 minutes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| range of motion | The range or motion of shoulder, elbow and wrist will be assessed by goniometer. The assessment will be done before starting the intervention as the baseline and then after finishing the intervention to detect change of range of motion from the the baseline. The range of motion will be reported in degrees. | before starting the intervention and after finishing the intervention within 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and block test | The name 'box and block test' is an unabbreviated scale title. The minimum score is zero and the maximum score is infinity. | before starting the intervention and after finishing the intervention within 1 week | 
| ABILHANDS-Kids | The ABILHANDS-kids is the name of the test. It is not an unabbreviated name. The children will be asked the difficulty of doing their activities of daily living by using 21 questionnaires. The rating of difficulties were impossible, difficult and easy. Then the rating would be score as impossible=0, difficult=1 and easy = 2. The analysis of the score of there items will use the Rasch analysis which it is available online on http://rssandbox.iescagilly.be/ abilhand-kids-cerebral-palsy-en.html. The minimum score means a worse outcome and the maximum score means the better outcome. | before starting the intervention and after finishing the intervention within 1 week | 
| EQ-5D-Y | The EQ-5D-Y is a questionnaire which has 2 parts for a participants to complete. There are 5 questions asking in first part: mobility, looking after myself, doing usual activities, having pain or discomfort and feelin worried, sad or unhappy. The participant needs to rate these questions in 3 rating score: no problem, with some problem or with a lot of problem. The rating score will be coded as no problem=1, with some problem = 1 and with a lot of problem = 2. The code 11111 is the best condition and the code 33333 is the worst condition. The second part of the questionnaire is the EQ-VAS which the participants need to rate their condition on the linear scale from 0-100. The worst condition is score 0 and the best condition is score 100.Then the coding from the first part will be converted as an index value. | before starting the intervention and after finishing the intervention within 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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video-game, Kinect sensor, upper extremities problems, cerebral palsy, children