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

Hemiplegic Cerebral Palsy Clinical Trial

Official title:

"Remind to Move" Treatment Versus Constraint-induced Movement Therapy for Children With Hemiplegic Cerebral Palsy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645331
• Other study ID #: HSEARS20130214003
• Status: Completed
• Phase: N/A
• First received: December 23, 2015
• Last updated: December 31, 2015
• Start date: February 2013
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: University Grants Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegia
• Hemiplegic Cerebral Palsy
• Upper Extremity Hemiplegia

Intervention

Behavioral:
• Remind-to-move

• Modified constraint induced movement therapy

• Conventional rehabilitation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

References & Publications (2)

Dong AV, Fong NK. Remind to move - A novel treatment on hemiplegic arm functions in children with unilateral cerebral palsy: A randomized cross-over study. Dev Neurorehabil. 2015 Aug 24:1-9. [Epub ahead of print] — View Citation

Fong KN, Jim ES, Dong VA, Cheung HK. 'Remind to move': a pilot study on the effects of sensory cueing treatment on hemiplegic upper limb functions in children with unilateral cerebral palsy. Clin Rehabil. 2013 Jan;27(1):82-9. doi: 10.1177/0269215512448199. Epub 2012 Jul 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Jebsen-Taylor Hand Function Test (JTHFT)		Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)	No
Primary	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)	No
Secondary	Caregiver Functional Use Survey (CFUS)		Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Power grip strength as measured by dynamometer		Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)	No