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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02801279
• Other study ID #: 201503112RIND
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2017
• Est. completion date: December 2024

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

The inclusion criteria of children with CP are:

1. diagnosed with congenital hemiplegic

2. no excessive muscle tone (Modified Ashworth Scale = 3 at any joints of the upper limb)

The exclusion criteria of children with CP are:

1. have severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation

2. have injections of botulinum toxin type A.

The inclusion criteria of typically developing children are:

1. absence of medical or developmental diseases which would affect physical and cognitive performances

2. having normal corrected vision

3. 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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

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

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 of Kinematic analysis		baseline, after 8 weeks, after 6 months
Secondary	Change of muscle strength		baseline, after 8 weeks, after 6 months
Secondary	Score change of Melbourne Assessment 2 (MA-2)		baseline, after 4 weeks, after 8 weeks, after 6 months
Secondary	Score change of Pediatric Motor Activity Log-Revised (PMAL-R)		baseline, after 4 weeks, after 8 weeks, after 6 months
Secondary	Score change of ABILHAND-Kids		baseline, after 4 weeks, after 8 weeks, after 6 months
Secondary	Score change of Test of Playfulness (ToP)		baseline, after 4 weeks, after 8 weeks, after 6 months
Secondary	Score change of Box and Block Test (BBT)		baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months
Secondary	Score change of Engagement Questionnaire (EQ)		baseline, after 4 weeks, after 8 weeks, after 6 months
Secondary	Score change of Satisfactory Questionnaire (SQ)		baseline, after 4 weeks, after 8 weeks, after 6 months
Secondary	Score change of Building Tower Test (BTT)		baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months
Secondary	Score change of String Beads Test (SBT)		baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months
Secondary	Score change of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)		baseline, after 4 weeks, after 8 weeks, after 6 months
Secondary	Score change of Pediatric Evaluation of Disability Inventory (PEDI)		baseline, after 4 weeks, after 8 weeks, after 6 months
Secondary	Score change of Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL)		baseline, after 4 weeks, after 8 weeks, after 6 months
Secondary	Score change of Parenting Stress Index-Short Form (PSI-short)		baseline, after 4 weeks, after 8 weeks, after 6 months
Secondary	Score change of Test of Visual Perceptual Skills		baseline, after 4 weeks, after 8 weeks, after 6 months