Kinect Sensor in Cerebral Palsy Children Phase 2.2

M

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

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.

Trial contacts and locations

1

Loading...

Central trial contact

Apiphan Iamchaimongkol, MD.; Sivaporn Vongpipatana, MD.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems