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

Study Overview
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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.

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

Conditions
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Hemiplegic Cerebral Palsy, Upper Extremity Hemiplegia

Intervention / Treatment
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* Behavioral: Remind-to-move
* Behavioral: Modified constraint induced movement therapy
* Behavioral: Conventional rehabilitation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remind-to-move<br>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. | Behavioral: Remind-to-move<br> <br> |
| Active Comparator: Modified constraint induced movement therapy (mCIMT)<br>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. | Behavioral: Modified constraint induced movement therapy<br> <br> |
| Placebo Comparator: Conventional rehabilitation<br>Conventional splinting, muscle strengthening, stretching, and neurodevelopmental facilitation techniques for 1hr daily, 2 day per week for 3 weeks. | Behavioral: Conventional rehabilitation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |