Kinect Sensor in Cerebral Palsy Children Phase 2.2

Mahidol University

Status: Enrolling

Conditions: Cerebral Palsy Children; Upper Extremity Problem

Treatments: Device: The engineer-built system, video-game based Kinect sensor

Study type: Interventional

Funder types: Other

Identifiers

NCT05328466

MURA2021/768-2.2

Details and patient eligibility

About

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".

Enrollment: 48 estimated patients

Sex: All

Ages: 10 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

video game in CP children

Experimental group

Description:

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.

Treatment:

Device: The engineer-built system, video-game based Kinect sensor

Conventional therapy

No Intervention group

Description:

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.