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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05311358
Other study ID # MURA2021/768
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2022
Est. completion date June 21, 2022

Study information

Verified date June 2022
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There are 3 phases of this project. First phase is to study the satisfaction in healthy children aged 10-15 years old when they are playing our computer games. The sample size of this phase was 10. In addition, we will ask the occupational therapist to play and comment our game for further development.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date June 21, 2022
Est. primary completion date June 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 15 Years
Eligibility Inclusion Criteria: - Normal children aged 10-15 years - Sufficient cognitive/attention capacity - Give the informed consent Exclusion Criteria: - Inability to understand the instruction and follow the task - Has severe visual or auditory impairment - Has limb deformities that interfere with video game playing - Got an epilepsy or convulsive condition - Denied to give the informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Device:
The engineer-built system, video-game based Kinect sensor
There are 3 computer games using Kinect sensor to detect movement of trunk and upper extremities of the children.

Locations

Country Name City State
Thailand Faculty of Medicine Ramathibodi Hospital Mahidol University Bangkok

Sponsors (4)

Lead Sponsor Collaborator
Mahidol University Apiphan Iamchaimongkol, Tulyapruek Tawonsawatruk, Warakorn Charoensuk

Country where clinical trial is conducted

Thailand, 

References & Publications (9)

7. 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.

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. — View Citation

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. — View Citation

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. Epub 2007 Sep 25. — View Citation

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. — View Citation

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. — View Citation

Paneth N, Hong T, Korzeniewski S. The descriptive epidemiology of cerebral palsy. Clin Perinatol. 2006 Jun;33(2):251-67. Review. — View Citation

Prevalence and characteristics of children with cerebral palsy in Europe. Dev Med Child Neurol. 2002 Sep;44(9):633-40. — View Citation

Pruksananonda C. Cerebral palsy. In: Prasongjean P, editor. Cerebral Palsy. Bangkok: Chulolongkorn University Printing House; 2010. p. 1-3.

Outcome

Type Measure Description Time frame Safety issue
Primary satisfaction form The satisfaction form will be evaluated by healthy children. The satisfaction form will ask the children to rate the games in the following subjects: the presentation of game, the contents of game, the convenience for users the feeling after playing and the further suggestion about the games. There are 5-likert-scale in the satisfaction form: totally disagree, disagree, neutral, agree and totally agree. immediately after playing game
Secondary Satisfaction form The satisfaction form will be evaluated by occupational therapists. The satisfaction form will ask the therapist to rate the games in the following subjects: the presentation of game, the contents of game, the convenience for users the feeling after playing and the further suggestion about the games. There are 5-likert-scale in the satisfaction form: totally disagree, disagree, neutral, agree and totally agree. immediately after playing game
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