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

June 21, 2022 updated by: Sivaporn Vongpipatana, Mahidol University
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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bangkok, Thailand, 10400
        • Faculty of Medicine Ramathibodi Hospital Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normal children
Normal children aged 10-15 years play the game and comment on the satisfaction form
There are 3 computer games using Kinect sensor to detect movement of trunk and upper extremities of the children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
satisfaction form
Time Frame: immediately after playing game
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction form
Time Frame: immediately after playing game
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2022

Primary Completion (Actual)

June 21, 2022

Study Completion (Actual)

June 21, 2022

Study Registration Dates

First Submitted

March 8, 2022

First Submitted That Met QC Criteria

April 3, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 21, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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