"Remind to Move" Treatment Versus Constraint-induced Movement Therapy for Children With Hemiplegic Cerebral Palsy

Not Applicable

Completed

• Conditions: Upper Extremity Hemiplegia; Hemiplegic Cerebral Palsy

• Registration Number: NCT02645331
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

The aim of this study was to determine the effects of an innovative child-friendly remind-to-move treatment (RTM) treatment by comparing it with constraint-induced movement therapy (CIMT) on upper extremity outcomes in children with hemiplegic Cerebral Palsy. In an evaluator-blinded randomized controlled trial, 73 children, among of whom 20 in Manual Ability Classification System level I, 38 level II, and 15 level III, were recruited from 3 special schools and randomized to receive 75-hour RTM (n=25) and CIMT (n=24) programme over 15-weekdays, and conventional treatment (n=24). The primary outcomes were Jebsen-Taylor Hand Function Test (JTHFT) and Bruininks-Oseretsky Test of Motor Proficiency (BOTMP-II) Subtest 3 for assessing the motor efficiency at baseline, posttest, and 1- and 3-month follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-12
• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2015-12-31
• Last Update Submitted: 2015-12-31
• Study First Posted: 2016-01-01
• Last Update Posted: 2016-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Diagnosis of Hemiplegic Cerebral Palsy
• Aged 5 to 16 years
• Ability to follow instructions
• Ability to grasp and release light objects, and at least 20° wrist and 10°fingers in metacarpophalangeal joints extension from full flexion for the affected hand
• Manual Activity Classification System (MACS) 19 grades I, II or III of the affected hand

Exclusion Criteria

• Severe cognitive, visual, or auditory disorder
• Seizure and health problems not associated with cerebral palsy
• Predominant spasticity or contracture grades more than 3 of Modified Ashworth Scale 20 on wrist and finger flexors, forearm pronators and ⁄ or thumb adductors
• Receiving new pharmaceutical (i.e. botulinum toxin injections) and/or surgical interventions within 6-month before study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Jebsen-Taylor Hand Function Test (JTHFT)	Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
Bruininks-Oseretsky Test of Motor Proficiency (2nd ed.) (BOTMP-II)	Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)

Secondary Outcome Measures

Name	Time	Method
Caregiver Functional Use Survey (CFUS)	Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
Ratio of movement duration on the affected hand from accelerometer	Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
Active range of motion (AROM) as measured by digital goniometer	Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
Power grip strength as measured by dynamometer	Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)