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The Engineer-Built System, Video-Game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring video-game based Kinect sensor, upper extremities

Eligibility Criteria

10 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Faculty of Medicine Ramathibodi Hospital Mahidol University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Normal children

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05311358

First Posted

March 8, 2022

Last Updated

June 21, 2022

Sponsor

Mahidol University

Collaborators

Warakorn Charoensuk, Apiphan Iamchaimongkol, Tulyapruek Tawonsawatruk

1. Study Identification

Unique Protocol Identification Number

NCT05311358

Brief Title

The Engineer-Built System, Video-Game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children

Official Title

The Engineer-Built System, Video-Game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

May 10, 2022 (Actual)

Primary Completion Date

June 21, 2022 (Actual)

Study Completion Date

June 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

Collaborators

Warakorn Charoensuk, Apiphan Iamchaimongkol, Tulyapruek Tawonsawatruk

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

video-game based Kinect sensor, upper extremities

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal children

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

satisfaction form

Description

Time Frame

immediately after playing game

Secondary Outcome Measure Information:

Title

Satisfaction form

Description

Time Frame

immediately after playing game

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Faculty of Medicine Ramathibodi Hospital Mahidol University

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

IPD Sharing 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.

IPD Sharing Access Criteria

using code number of the participants

Citations:

PubMed Identifier

21122742

Citation

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.

Results Reference

background

PubMed Identifier

16437058

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.

Results Reference

background

PubMed Identifier

16765723

Citation

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.

Results Reference

background

PubMed Identifier

12227618

Citation

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

Results Reference

background

PubMed Identifier

24819682

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.

Results Reference

background

Citation

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.

Results Reference

background

PubMed Identifier

17895352

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. doi: 10.2522/ptj.20060062. Epub 2007 Sep 25.

Results Reference

background

PubMed Identifier

21978233

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.

Results Reference

background

Citation

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

Results Reference

background

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The Engineer-Built System, Video-Game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children

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