NCT05311358

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 10, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2022

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

March 8, 2022

Last Update Submit

June 21, 2022

Conditions

Keywords

video-game based Kinect sensorupper extremities

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Satisfaction form

    immediately after playing game

Study Arms (1)

Normal children

EXPERIMENTAL

Normal children aged 10-15 years play the game and comment on the satisfaction form

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

Interventions

There are 3 computer games using Kinect sensor to detect movement of trunk and upper extremities of the children.

Normal children

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Normal children aged 10-15 years
  • Sufficient cognitive/attention capacity
  • Give the informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Ramathibodi Hospital Mahidol University

Bangkok, 10400, Thailand

Location

Related Publications (9)

  • 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.

    PMID: 21122742BACKGROUND
  • 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.

    PMID: 16437058BACKGROUND
  • 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.

    PMID: 16765723BACKGROUND
  • Prevalence and characteristics of children with cerebral palsy in Europe. Dev Med Child Neurol. 2002 Sep;44(9):633-40.

    PMID: 12227618BACKGROUND
  • 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.

    PMID: 24819682BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 17895352BACKGROUND
  • 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.

    PMID: 21978233BACKGROUND
  • Pruksananonda C. Cerebral palsy. In: Prasongjean P, editor. Cerebral Palsy. Bangkok: Chulolongkorn University Printing House; 2010. p. 1-3.

    BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: In the first phase, we will test our video-game based Kinect sensor in healthy children aged 10-12 years old. The healthy children and the occupational therapists have to reply the satisfaction form and comment our game for further improvement. The sample size of this phase is 10.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 8, 2022

First Posted

April 5, 2022

Study Start

May 10, 2022

Primary Completion

June 21, 2022

Study Completion

June 21, 2022

Last Updated

June 24, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

I will share the information on satisfaction form with the engineers who developed game for game improvement.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The study protocol will be share among the researcher team during study period. The statistical analysis plan will be share with the statistician during the analysis and summarize period.
Access Criteria
using code number of the participants

Locations