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

NCT02645331 | Completed

• 1 other identifier: HSEARS20130214003
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemiplegic Cerebral Palsy; Upper Extremity Hemiplegia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

Study Arms (3)

Remind-to-move

EXPERIMENTAL

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

Modified constraint induced movement therapy (mCIMT)

ACTIVE COMPARATOR

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

Conventional rehabilitation

PLACEBO COMPARATOR

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

Behavioral: Conventional rehabilitation

Interventions

Remind-to-move BEHAVIORAL

Remind-to-move

Modified constraint induced movement therapy BEHAVIORAL

Modified constraint induced movement therapy (mCIMT)

Conventional rehabilitation BEHAVIORAL

Conventional rehabilitation

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Related Publications (2)

• 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.

  PMID: 22801471 BACKGROUND

• 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.

  PMID: 25548861 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: January 1, 2016
• Study Start: February 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 1, 2016

Record last verified: 2015-12