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

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Constraint-induced therapy
kinect-based constraint-induced therapy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Neurological Rehabilitation, Upper Extremity

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

constraint-induced therapy

kinect-based constraint-induced therapy

Arm Description

training of the more affected arm and restraint the less affected arm

training of the more affected arm and restraint the less affected arm by kinect-game

Outcomes

Primary Outcome Measures

Performance Change assessed by Kinematic analysis
Kinematic analysis including measuring the parameters of endpoint control, joint recruitment and inter-joint coordination, and trunk involvement.

Secondary Outcome Measures

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

Full Information

First Posted
May 24, 2016
Last Updated
February 16, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02808195
Brief Title
Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy
Official Title
Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2016 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Neurological Rehabilitation, Upper Extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
constraint-induced therapy
Arm Type
Experimental
Arm Description
training of the more affected arm and restraint the less affected arm
Arm Title
kinect-based constraint-induced therapy
Arm Type
Experimental
Arm Description
training of the more affected arm and restraint the less affected arm by kinect-game
Intervention Type
Other
Intervention Name(s)
Constraint-induced therapy
Intervention Type
Other
Intervention Name(s)
kinect-based constraint-induced therapy
Primary Outcome Measure Information:
Title
Performance Change assessed by Kinematic analysis
Description
Kinematic analysis including measuring the parameters of endpoint control, joint recruitment and inter-joint coordination, and trunk involvement.
Time Frame
baseline, 2 months and 6 months
Secondary Outcome Measure Information:
Title
score change of Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2)
Time Frame
baseline, 1 months, 2 months and 6 months
Title
score change of Melbourne Assessment 2 (MA2)
Time Frame
baseline, 1 months, 2 months and 6 months
Title
score change of Pediatric Motor Activity Log-Revised (PMAL-R)
Time Frame
baseline, 1 months, 2 months and 6 months
Title
score change of ABILHAND-kids
Time Frame
baseline, 1 months, 2 months and 6 months
Title
score change of Functional Independence Measures for children (WeeFIM)
Time Frame
baseline, 1 months, 2 months and 6 months
Title
score change of Pediatric evaluation of disability inventory (PEDI)
Time Frame
baseline, 1 months, 2 months and 6 months
Title
score change of Cerebral Palsy Quality of Life Questionnaire for Children (CP-QOL)
Time Frame
baseline, 1 months, 2 months and 6 months
Title
score change of Test of Visual Perceptual Skills-3rd (TVPS-3)
Time Frame
baseline, 1 months, 2 months and 6 months
Title
score change of Test of Playfulness (TOP)
Time Frame
baseline, 1 months, 2 months and 6 months
Title
score change of Engagement Questionnaire (EQ)
Time Frame
baseline, 1 months, 2 months and 6 months
Title
score change of Clint Satisfaction Questionnaire (CSQ)
Time Frame
baseline, 1 months, 2 months and 6 months
Title
score change of Parenting Stress Index-Short Form (PSI-SF)
Time Frame
baseline, 1 months, 2 months and 6 months
Title
Muscle strength
Description
measured by electromyography
Time Frame
baseline, 2 months and 6 months
Title
score change of Building Tower Test
Time Frame
baseline, 1 months, 2 months and 6 months
Title
score change of Test of String Beads
Time Frame
baseline, 1 months, 2 months and 6 months
Title
score change of Box and Block Test
Time Frame
baseline, 1 months, 2 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria are: 3-16 years old diagnosed with congenital hemiplegic or CP with one more affected side considerable nonuse of the affected upper limb. Exclusion criteria are: no excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon & Smith, 1987) no severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation no injections of botulinum toxin type A or operations on the upper limb within 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hao-Ling Chen
Phone
886-2-3366-8162
Email
hlchen@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Hao-Ling Chen
Phone
886-2-3366-8162
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao-Ling Chen
Organizational Affiliation
National Taiwan University
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
Email
hlchen@ntu.edu.tw

12. IPD Sharing Statement

Citations:
PubMed Identifier
34765593
Citation
Chen HL, Lin SY, Yeh CF, Chen RY, Tang HH, Ruan SJ, Wang TN. Development and Feasibility of a Kinect-Based Constraint-Induced Therapy Program in the Home Setting for Children With Unilateral Cerebral Palsy. Front Bioeng Biotechnol. 2021 Oct 26;9:755506. doi: 10.3389/fbioe.2021.755506. eCollection 2021.
Results Reference
derived

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

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