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

December 31, 2015 updated by: Kenneth N. K. Fong, The Hong Kong Polytechnic University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: Remind-to-move
ACTIVE_COMPARATOR: 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.
Behavioral: Modified constraint induced movement therapy
PLACEBO_COMPARATOR: Conventional rehabilitation
Conventional splinting, muscle strengthening, stretching, and neurodevelopmental facilitation techniques for 1hr daily, 2 day per week for 3 weeks.
Behavioral: Conventional rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Jebsen-Taylor Hand Function Test (JTHFT)
Time Frame: Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
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)
Time Frame: Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)

Secondary Outcome Measures

Outcome Measure
Time Frame
Caregiver Functional Use Survey (CFUS)
Time Frame: Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
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
Time Frame: Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
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
Time Frame: Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
Power grip strength as measured by dynamometer
Time Frame: Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

December 23, 2015

First Submitted That Met QC Criteria

December 31, 2015

First Posted (ESTIMATE)

January 1, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 1, 2016

Last Update Submitted That Met QC Criteria

December 31, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20130214003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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