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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Kinect-based bilateral arm training; Other: Conventional bilateral arm training

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kinect-based bilateral arm training; The Kinect-based bilateral arm training focuses activities that required the use of both hands by using Kinect game.	Other: Kinect-based bilateral arm training; The conventional bilateral arm training focuses activities that required the use of both hands.
Experimental: Conventional bilateral arm training; The conventional bilateral arm training focuses activities that required the use of both hands.	Other: Conventional bilateral arm training; The Kinect-based bilateral arm training focuses activities that required the use of both hands by using Kinect game.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Performance change of Kinematic analysis	baseline, after 8 weeks, after 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Hao-Ling Chen, Taiwan University, Department of Occupational Therapy

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2017
• Primary Completion (Actual): June 4, 2024
• Study Completion (Actual): June 4, 2024

Study Registration Dates

• First Submitted: June 13, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (Estimated): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Occupational Therapy; Upper Limb Motor Training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: 201503112RIND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No