NCT02801279

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

March 4, 2017

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2024

Completed
Last Updated

September 20, 2024

Status Verified

June 1, 2024

Enrollment Period

7.3 years

First QC Date

June 13, 2016

Last Update Submit

September 18, 2024

Conditions

Keywords

Cerebral PalsyOccupational TherapyUpper Limb Motor Training

Outcome Measures

Primary Outcomes (1)

  • Performance change of Kinematic analysis

    baseline, after 8 weeks, after 6 months

Secondary Outcomes (15)

  • 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

  • +10 more secondary outcomes

Study Arms (2)

Kinect-based bilateral arm training

EXPERIMENTAL

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

Conventional bilateral arm training

EXPERIMENTAL

The conventional bilateral arm training focuses activities that required the use of both hands.

Other: Conventional bilateral arm training

Interventions

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

Conventional bilateral arm training

The conventional bilateral arm training focuses activities that required the use of both hands.

Kinect-based bilateral arm training

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • diagnosed with congenital hemiplegic
  • no excessive muscle tone (Modified Ashworth Scale ≤ 3 at any joints of the upper limb)

You may not qualify if:

  • have severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
  • have injections of botulinum toxin type A.
  • absence of medical or developmental diseases which would affect physical and cognitive performances
  • having normal corrected vision
  • studying in regular education classroom in primary school for the 6-12 year-old children.
  • (1) having score not within normal limits in BOTMP-short form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Hao-Ling Chen

    Taiwan University, Department of Occupational Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 15, 2016

Study Start

March 4, 2017

Primary Completion

June 4, 2024

Study Completion

June 4, 2024

Last Updated

September 20, 2024

Record last verified: 2024-06

Locations