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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02808195
• Other study ID #: 201601057RINB
• Status: Recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: April 2025

Study information

• Verified date: February 2024
• Source: National Taiwan University Hospital
• Contact: Hao-Ling Chen
• Phone: 886-2-3366-8162
• Email: hlchen[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• Constraint-induced therapy

• kinect-based constraint-induced therapy

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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