Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy

February 14, 2024 updated by: National Taiwan University Hospital
The aims of the present study is to evaluate the effectiveness of Kinect-based upper limb motor rehabilitation system (ULMTS) program on motor performance and functional outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The specific aims of this study project will be:

To compare the effectiveness of intervention groups using Kinect-based ULMTS with constraint-induced therapy on motor improvement in children with hemiplegic CP. The investigators hypothesize that motor improvement in using Kinect-based ULMTS will be comparable to constraint-induced therapy.

Study Type

Interventional

Enrollment (Estimated)

60

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

  • Name: Hao-Ling Chen
  • Phone Number: 886-2-3366-8162

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10048
        • Recruiting
        • National Taiwan University Hospital
        • 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

3 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion criteria are:

  1. 3-16 years old
  2. diagnosed with congenital hemiplegic or CP with one more affected side
  3. considerable nonuse of the affected upper limb.

Exclusion criteria are:

  1. no excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon & Smith, 1987)
  2. no severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
  3. no injections of botulinum toxin type A or operations on the upper limb within 6 months.

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: constraint-induced therapy
training of the more affected arm and restraint the less affected arm
Other: Constraint-induced therapy
Experimental: kinect-based constraint-induced therapy
training of the more affected arm and restraint the less affected arm by kinect-game
Other: kinect-based constraint-induced therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance Change assessed by Kinematic analysis
Time Frame: baseline, 2 months and 6 months
Kinematic analysis including measuring the parameters of endpoint control, joint recruitment and inter-joint coordination, and trunk involvement.
baseline, 2 months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
score change of Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2)
Time Frame: baseline, 1 months, 2 months and 6 months
baseline, 1 months, 2 months and 6 months
score change of Melbourne Assessment 2 (MA2)
Time Frame: baseline, 1 months, 2 months and 6 months
baseline, 1 months, 2 months and 6 months
score change of Pediatric Motor Activity Log-Revised (PMAL-R)
Time Frame: baseline, 1 months, 2 months and 6 months
baseline, 1 months, 2 months and 6 months
score change of ABILHAND-kids
Time Frame: baseline, 1 months, 2 months and 6 months
baseline, 1 months, 2 months and 6 months
score change of Functional Independence Measures for children (WeeFIM)
Time Frame: baseline, 1 months, 2 months and 6 months
baseline, 1 months, 2 months and 6 months
score change of Pediatric evaluation of disability inventory (PEDI)
Time Frame: baseline, 1 months, 2 months and 6 months
baseline, 1 months, 2 months and 6 months
score change of Cerebral Palsy Quality of Life Questionnaire for Children (CP-QOL)
Time Frame: baseline, 1 months, 2 months and 6 months
baseline, 1 months, 2 months and 6 months
score change of Test of Visual Perceptual Skills-3rd (TVPS-3)
Time Frame: baseline, 1 months, 2 months and 6 months
baseline, 1 months, 2 months and 6 months
score change of Test of Playfulness (TOP)
Time Frame: baseline, 1 months, 2 months and 6 months
baseline, 1 months, 2 months and 6 months
score change of Engagement Questionnaire (EQ)
Time Frame: baseline, 1 months, 2 months and 6 months
baseline, 1 months, 2 months and 6 months
score change of Clint Satisfaction Questionnaire (CSQ)
Time Frame: baseline, 1 months, 2 months and 6 months
baseline, 1 months, 2 months and 6 months
score change of Parenting Stress Index-Short Form (PSI-SF)
Time Frame: baseline, 1 months, 2 months and 6 months
baseline, 1 months, 2 months and 6 months
Muscle strength
Time Frame: baseline, 2 months and 6 months
measured by electromyography
baseline, 2 months and 6 months
score change of Building Tower Test
Time Frame: baseline, 1 months, 2 months and 6 months
baseline, 1 months, 2 months and 6 months
score change of Test of String Beads
Time Frame: baseline, 1 months, 2 months and 6 months
baseline, 1 months, 2 months and 6 months
score change of Box and Block Test
Time Frame: baseline, 1 months, 2 months and 6 months
baseline, 1 months, 2 months and 6 months

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Hao-Ling Chen, National Taiwan 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)

August 1, 2016

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

May 24, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimated)

June 21, 2016

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201601057RINB

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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