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Cerebral Palsy ChildrenNCT05328466

Kinect Sensor in Cerebral Palsy Children Phase 2.2

A study testing The engineer-built system, video-game based Kinect sensor in people with Cerebral Palsy Children and Upper Extremity Problem, run by Mahidol University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 10 to 15 years
What is being tested?
The engineer-built system, video-game based Kinect sensor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteThailand
Study dates
9 Jun 2022to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Sivaporn Vongpipatana, MD. contact

022011154

sivaporn.vop@mahidol.ac.th

Apiphan Iamchaimongkol, MD. contact

022011154

beebie18z@gmail.com

Thailand1 site, 1 recruiting

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

    Nonthaburi

    Amprai Surit, occupational therapist, s_amprai@hotmail.com

    Recruiting

Other trials in Thailand

About this study

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

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".

Being tested
The engineer-built system, video-game based Kinect sensor
Keywords
video-game, Kinect sensor, upper extremities problems, cerebral palsy, children
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The engineer-built system, video-game based Kinect sensorDevice

    Also called conventional occupational therapy program

    The games were developed by the researcher team.

Study groups in NCT05328466
Study groupRoleWhat they receive
video game in CP childrenExperimentalChildren 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.
Receives: Device: The engineer-built system, video-game based Kinect sensor
Conventional therapyNo interventionchildren 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: before starting the intervention and after finishing the intervention within 1 week

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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 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.

    Measured: before starting the intervention and after finishing the intervention within 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2022
  2. Study start9 Jun 2022
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05328466
Sponsor's protocol ID
MURA2021/768-2.2
Status last verified
Sep 2022
First submitted
25 Mar 2022
Last updated
19 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: I plan to share the result with the statistician and some researcher for the analysis. The sharing could not be track to the patient identification.

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.

    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.

Questions about this trial

What is this clinical trial studying?

A study testing The engineer-built system, video-game based Kinect sensor in people with Cerebral Palsy Children and Upper Extremity Problem, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sivaporn Vongpipatana, MD. (022011154, sivaporn.vop@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

range of motion (time frame: before starting the intervention and after finishing the intervention within 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05328466, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.

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