CClinicalTrials.gg
WithdrawnNCT05338229Updated Sep 19, 2022

Kinect Sensor in Cerebral Palsy Children: Phase 2.1

An interventional study of the engineer-built system, video-game based Kinect sensor in Cerebral Palsy Children and Upper Extremity Problem, sponsored by Mahidol University. Withdrawn. Open to participants aged 10 Years to 15 Years. Per ClinicalTrials.gov, last updated 2022-09-19.

Sponsored by Mahidol University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Protocal changing due to time limitation
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
10 Years to 15 Years
Sex
All
01

Study summary

There are 3 phases of the study. This registration is phase 2.1.This registration will conduct a pilot study in the cerebral palsy children.

02

Conditions studied

  • Cerebral Palsy Children
  • Upper Extremity Problem

Keywords

  • video-game
  • Kinect sensor
  • upper extremities problems
  • cerebral palsy
  • children
03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

Browse Paralysis studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    video game in CP children (pilot study)

    The cerebral palsy children will play the engineer-built system, video-game based Kinect sensor 3 times/week for 5 weeks. Each session will last for 40 minutes. The video-game Kinect sensor was developed by the researcher team.

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

Interventions

  • Devicethe engineer-built system, video-game based Kinect sensor

    The engineer-built system, video-game based Kinect sensor was developed by the researcher team.

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. EQ-5D-Y

    The EQ-5D-Y is a questionnaire which has 2 parts for a participant 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.

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

Other outcomes

  1. patient satisfaction form

    The patient satisfaction form is about the questionnaire asking about the satisfaction of playing game in these areas: the presentation of games: the contents of game, the convenience and the outcome after playing game. The participants will rate each question in 5-likert scale: totally disagree, disagree, neutral, agree and totally agree.

    Time frame: immediately after finishing the intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Arneson CL, Durkin MS, Benedict RE, Kirby RS, Yeargin-Allsopp M, Van Naarden Braun K, Doernberg NS. Prevalence of cerebral palsy: Autism and Developmental Disabilities Monitoring Network, three sites, United States, 2004. Disabil Health J. 2009 Jan;2(1):45-8. doi: 10.1016/j.dhjo.2008.08.001. PubMed 21122742 ↗
  • Bhasin TK, Brocksen S, Avchen RN, Van Naarden Braun K. Prevalence of four developmental disabilities among children aged 8 years--Metropolitan Atlanta Developmental Disabilities Surveillance Program, 1996 and 2000. MMWR Surveill Summ. 2006 Jan 27;55(1):1-9. Erratum In: MMWR Morb Mortal Wkly Rep. 2006 Feb 3;55(4):105-6. PubMed 16437058 ↗
  • Paneth N, Hong T, Korzeniewski S. The descriptive epidemiology of cerebral palsy. Clin Perinatol. 2006 Jun;33(2):251-67. doi: 10.1016/j.clp.2006.03.011. PubMed 16765723 ↗
  • Prevalence and characteristics of children with cerebral palsy in Europe. Dev Med Child Neurol. 2002 Sep;44(9):633-40. PubMed 12227618 ↗
  • Chen YP, Lee SY, Howard AM. Effect of virtual reality on upper extremity function in children with cerebral palsy: a meta-analysis. Pediatr Phys Ther. 2014 Fall;26(3):289-300. doi: 10.1097/PEP.0000000000000046. PubMed 24819682 ↗
  • Samia Abdel Rahman, Abdel Rahman, Afaf A. Shaheen. Virtual Reality Use in Motor Rehabilitation of Neurological Disorders: A Systematic Review. Middle-East Journal of Scientific Research; 7 (1): 63-70.
  • Chen YP, Kang LJ, Chuang TY, Doong JL, Lee SJ, Tsai MW, Jeng SF, Sung WH. Use of virtual reality to improve upper-extremity control in children with cerebral palsy: a single-subject design. Phys Ther. 2007 Nov;87(11):1441-57. doi: 10.2522/ptj.20060062. Epub 2007 Sep 25. PubMed 17895352 ↗
  • Green D, Wilson PH. Use of virtual reality in rehabilitation of movement in children with hemiplegia--a multiple case study evaluation. Disabil Rehabil. 2012;34(7):593-604. doi: 10.3109/09638288.2011.613520. Epub 2011 Oct 6. PubMed 21978233 ↗
  • Pruksananonda C. Cerebral Palsy. In: Prasongjean P, editor. Cerebral Palsy Disease. Bangkok: Chulalongkorn University Printing House; 2010. p. 1-3.

Individual participant data

Plan to share: Yes — I plan to share the information about the result of the study with the statistician and some team members for the analysis. The sharing will not be linked to the patient identification.

Supporting information: Sap, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05338229
Lead sponsor
Mahidol University
Collaborators
Warakorn Charoensuk, Apiphan Iamchaimongkol, Tulyapruek Tawonsawatruk
Responsible party
Sivaporn Vongpipatana (Assistant Professor, Mahidol University) — Principal investigator
First posted
Apr 21, 2022
Start date
Jun 2022 (estimated)
Primary completion
Dec 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Sep 19, 2022

Study contacts

Sivaporn Vongpipatana
principal investigator · Department of Rehabilitation Medicine, Faculty of Medicine Ramathibodi Hospital Mahidol University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion