Kinect Sensor in Cerebral Palsy Children Phase 2.2

Mahidol University48 enrolled

Overview

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".

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cerebral Palsy Children Upper Extremity Problem

Interventions

The engineer-built system, video-game based Kinect sensorDEVICE

The games were developed by the researcher team.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

Srisangwan School Foundation for the Welfare of the Crippled under Royal Patronage of Her Royal Highness the Princess Mother

Nonthaburi, Thailand

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: before starting the intervention and after finishing the intervention within 1 week

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Central Contacts

Sivaporn Vongpipatana, MD.

CONTACT

022011154 sivaporn.vop@mahidol.ac.th

Apiphan Iamchaimongkol, MD.

CONTACT

022011154 beebie18z@gmail.com

Data from ClinicalTrials.gov

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