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Development of Kinect-assisted Home-based Bilateral Arm Training Program for Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Conventional bilateral arm training

Kinect-based bilateral arm training

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Occupational Therapy, Upper Limb Motor Training

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

The inclusion criteria of children with CP are:

diagnosed with congenital hemiplegic
no excessive muscle tone (Modified Ashworth Scale ≤ 3 at any joints of the upper limb)

The exclusion criteria of children with CP are:

have severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
have injections of botulinum toxin type A.

The inclusion criteria of typically developing children are:

absence of medical or developmental diseases which would affect physical and cognitive performances
having normal corrected vision
studying in regular education classroom in primary school for the 6-12 year-old children.

The exclusion criteria of typically developing children are:

(1) having score not within normal limits in BOTMP-short form

Sites / Locations

National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Kinect-based bilateral arm training

Conventional bilateral arm training

Arm Description

The Kinect-based bilateral arm training focuses activities that required the use of both hands by using Kinect game.

The conventional bilateral arm training focuses activities that required the use of both hands.

Outcomes

Primary Outcome Measures

Performance change of Kinematic analysis

Secondary Outcome Measures

Change of muscle strength

Score change of Melbourne Assessment 2 (MA-2)

Score change of Pediatric Motor Activity Log-Revised (PMAL-R)

Score change of ABILHAND-Kids

Score change of Test of Playfulness (ToP)

Score change of Box and Block Test (BBT)

Score change of Engagement Questionnaire (EQ)

Score change of Satisfactory Questionnaire (SQ)

Score change of Building Tower Test (BTT)

Score change of String Beads Test (SBT)

Score change of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)

Score change of Pediatric Evaluation of Disability Inventory (PEDI)

Score change of Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL)

Score change of Parenting Stress Index-Short Form (PSI-short)

Score change of Test of Visual Perceptual Skills

Full Information

NCT ID

NCT02801279

First Posted

June 13, 2016

Last Updated

February 16, 2023

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02801279

Brief Title

Development of Kinect-assisted Home-based Bilateral Arm Training Program for Cerebral Palsy

Official Title

Development of Kinect-assisted Home-based Bilateral Arm Training Program for Cerebral Palsy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 4, 2017 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

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

The purpose of the present study is to develop a long term cost-effectiveness (efficient protocol, playful context, and practical strategy) training program for school-age children with Cerebral Palsy. Also, evaluate efficacy of Kinect-assisted bilateral arm training program for children with Cerebral Palsy.

6. Conditions and Keywords

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

Cerebral Palsy

Keywords

Cerebral Palsy, Occupational Therapy, Upper Limb Motor Training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Kinect-based bilateral arm training

Arm Type

Experimental

Arm Description

The Kinect-based bilateral arm training focuses activities that required the use of both hands by using Kinect game.

Arm Title

Conventional bilateral arm training

Arm Type

Experimental

Arm Description

The conventional bilateral arm training focuses activities that required the use of both hands.

Intervention Type

Other

Intervention Name(s)

Conventional bilateral arm training

Intervention Description

The Kinect-based bilateral arm training focuses activities that required the use of both hands by using Kinect game.

Intervention Type

Other

Intervention Name(s)

Kinect-based bilateral arm training

Intervention Description

The conventional bilateral arm training focuses activities that required the use of both hands.

Primary Outcome Measure Information:

Title

Performance change of Kinematic analysis

Time Frame

baseline, after 8 weeks, after 6 months

Secondary Outcome Measure Information:

Title

Change of muscle strength

Time Frame

baseline, after 8 weeks, after 6 months

Title

Score change of Melbourne Assessment 2 (MA-2)

Time Frame

baseline, after 4 weeks, after 8 weeks, after 6 months

Title

Score change of Pediatric Motor Activity Log-Revised (PMAL-R)

Time Frame

baseline, after 4 weeks, after 8 weeks, after 6 months

Title

Score change of ABILHAND-Kids

Time Frame

baseline, after 4 weeks, after 8 weeks, after 6 months

Title

Score change of Test of Playfulness (ToP)

Time Frame

baseline, after 4 weeks, after 8 weeks, after 6 months

Title

Score change of Box and Block Test (BBT)

Time Frame

baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months

Title

Score change of Engagement Questionnaire (EQ)

Time Frame

baseline, after 4 weeks, after 8 weeks, after 6 months

Title

Score change of Satisfactory Questionnaire (SQ)

Time Frame

baseline, after 4 weeks, after 8 weeks, after 6 months

Title

Score change of Building Tower Test (BTT)

Time Frame

baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months

Title

Score change of String Beads Test (SBT)

Time Frame

baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months

Title

Score change of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)

Time Frame

baseline, after 4 weeks, after 8 weeks, after 6 months

Title

Score change of Pediatric Evaluation of Disability Inventory (PEDI)

Time Frame

baseline, after 4 weeks, after 8 weeks, after 6 months

Title

Score change of Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL)

Time Frame

baseline, after 4 weeks, after 8 weeks, after 6 months

Title

Score change of Parenting Stress Index-Short Form (PSI-short)

Time Frame

baseline, after 4 weeks, after 8 weeks, after 6 months

Title

Score change of Test of Visual Perceptual Skills

Time Frame

baseline, after 4 weeks, after 8 weeks, after 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

The inclusion criteria of children with CP are: diagnosed with congenital hemiplegic no excessive muscle tone (Modified Ashworth Scale ≤ 3 at any joints of the upper limb) The exclusion criteria of children with CP are: have severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation have injections of botulinum toxin type A. The inclusion criteria of typically developing children are: absence of medical or developmental diseases which would affect physical and cognitive performances having normal corrected vision studying in regular education classroom in primary school for the 6-12 year-old children. The exclusion criteria of typically developing children are: (1) having score not within normal limits in BOTMP-short form

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hao-Ling Chen

Phone

886-2-3366-8162

hlchen@ntu.edu.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hao-Ling Chen

Organizational Affiliation

Taiwan University, Department of Occupational Therapy

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

10048

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hao-Ling Chen

Phone

886-2-3366-8162

hlchen@ntu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

Development of Kinect-assisted Home-based Bilateral Arm Training Program for Cerebral Palsy

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