Kinect Sensor in Cerebral Palsy Children Phase 2.2

September 16, 2022 updated by: Sivaporn Vongpipatana, Mahidol University

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".

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

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 Contact

Study Contact Backup

Study Locations

  • Thailand
      • Nonthaburi, Thailand
        • Recruiting
        • Srisangwan School Foundation for the Welfare of the Crippled under Royal Patronage of Her Royal Highness the Princess Mother
        • Contact:

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: video game in CP children
Children 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.
Device: The engineer-built system, video-game based Kinect sensor
The games were developed by the researcher team.
Other Names:
  • conventional occupational therapy program
No Intervention: Conventional therapy
children 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
range of motion
Time Frame: before starting the intervention and after finishing the intervention within 1 week
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.
before starting the intervention and after finishing the intervention within 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and block test
Time Frame: before starting the intervention and after finishing the intervention within 1 week
The name 'box and block test' is an unabbreviated scale title. The minimum score is zero and the maximum score is infinity.
before starting the intervention and after finishing the intervention within 1 week
ABILHANDS-Kids
Time Frame: before starting the intervention and after finishing the intervention within 1 week
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.
before starting the intervention and after finishing the intervention within 1 week
EQ-5D-Y
Time Frame: before starting the intervention and after finishing the intervention within 1 week
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.
before starting the intervention and after finishing the intervention within 1 week

Collaborators and Investigators

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

Sponsor

Mahidol University

Collaborators

Warakorn Charoensuk
Apiphan Iamchaimongkol
Tulyapruek Tawonsawatruk

Investigators

  • Principal Investigator: Sivaporn Vongpipatana, Department of Rehabilitation Medicine, Faculty of Medicine Ramathibodi Hospital Mahidol University

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)

June 9, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

March 25, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

September 19, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MURA2021/768-2.2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

after harvesting the data within 3 months

IPD Sharing Supporting Information Type

  • 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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