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

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

Sponsors

Lead Sponsor: The Hong Kong Polytechnic University

Source 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.

Overall Status Completed
Start Date February 2013
Completion Date September 2015
Primary Completion Date September 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure 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
Measure 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)
Enrollment 73
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Remind-to-move

Arm Group Label: Remind-to-move

Intervention Type: Behavioral

Intervention Name: Modified constraint induced movement therapy

Arm Group Label: Modified constraint induced movement therapy (mCIMT)

Intervention Type: Behavioral

Intervention Name: Conventional rehabilitation

Arm Group Label: Conventional rehabilitation

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

Gender: All

Minimum Age: 5 Years

Maximum Age: 16 Years

Healthy Volunteers: No

Verification Date

December 2015

Responsible Party

Type: Principal Investigator

Investigator Affiliation: The Hong Kong Polytechnic University

Investigator Full Name: Kenneth N. K. Fong

Investigator Title: Associate Professor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Remind-to-move

Type: Experimental

Description: 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.

Label: Modified constraint induced movement therapy (mCIMT)

Type: Active Comparator

Description: 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.

Label: Conventional rehabilitation

Type: Placebo Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov