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

NCT ID: NCT02645331

Last Updated: 2016-01-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-09-30

Brief Summary

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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

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Conditions

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Hemiplegic Cerebral Palsy Upper Extremity Hemiplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Remind-to-move

RTM involved a wristwatch device worn on more-affected arm which emitted sensory cueing continuously to remind the children to use the more-affected hand to engage in daily activities or complete bimanual tasks intensively, 5 hour per day, 5 days every week, for 3 consecutive weeks.

Group Type EXPERIMENTAL

Remind-to-move

Intervention Type BEHAVIORAL

Modified constraint induced movement therapy (mCIMT)

children were encouraged to wear a customer-made volar resting splint that extended from below the elbow to the fingertips on their noninvolved hands for 5 hour daily except for toileting, writing and specific physical sports, for 3 weeks. Each child was supervised by one therapist to complete structured unimanual practice with the affected hand during the supervised session, 5 days every week, for 3 consecutive weeks.

Group Type ACTIVE_COMPARATOR

Modified constraint induced movement therapy

Intervention Type BEHAVIORAL

Conventional rehabilitation

Conventional splinting, muscle strengthening, stretching, and neurodevelopmental facilitation techniques for 1hr daily, 2 day per week for 3 weeks.

Group Type PLACEBO_COMPARATOR

Conventional rehabilitation

Intervention Type BEHAVIORAL

Interventions

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Remind-to-move

Intervention Type BEHAVIORAL

Modified constraint induced movement therapy

Intervention Type BEHAVIORAL

Conventional rehabilitation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Kenneth N. K. Fong

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 22801471 (View on PubMed)

Dong AQ, 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. 2016 Oct;19(5):275-83. doi: 10.3109/17518423.2014.988304. Epub 2014 Dec 30.

Reference Type BACKGROUND
PMID: 25548861 (View on PubMed)

Other Identifiers

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HSEARS20130214003

Identifier Type: -

Identifier Source: org_study_id

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