Clinical trial NCT02645331: "Remind to Move" Treatment Versus Constraint-induced Movement Therapy for Children With Hemiplegic Cerebral Palsy
Official title: "Remind to Move" Treatment Versus Constraint-induced Movement Therapy for Children With Hemiplegic Cerebral Palsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Upper Extremity Hemiplegia
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 73
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Jebsen-Taylor Hand Function Test (JTHFT)
timeFrame: Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
measure: Bruininks-Oseretsky Test of Motor Proficiency (2nd ed.) (BOTMP-II)
timeFrame: Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
Secondary outcomes:
measure: Caregiver Functional Use Survey (CFUS)
timeFrame: Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
measure: Ratio of movement duration on the affected hand from accelerometer
timeFrame: Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
measure: Active range of motion (AROM) as measured by digital goniometer
timeFrame: Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
measure: Power grip strength as measured by dynamometer
timeFrame: Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.