Back to results

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

Primary Purpose

Hemiplegic Cerebral Palsy, Upper Extremity Hemiplegia

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Remind-to-move

Modified constraint induced movement therapy

Conventional rehabilitation

About this trial

This is an interventional treatment trial for Hemiplegic Cerebral Palsy

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Remind-to-move

Modified constraint induced movement therapy (mCIMT)

Conventional rehabilitation

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

Jebsen-Taylor Hand Function Test (JTHFT)

Bruininks-Oseretsky Test of Motor Proficiency (2nd ed.) (BOTMP-II)

Secondary Outcome Measures

Caregiver Functional Use Survey (CFUS)

Ratio of movement duration on the affected hand from accelerometer

Active range of motion (AROM) as measured by digital goniometer

Power grip strength as measured by dynamometer

Full Information

NCT ID

NCT02645331

First Posted

December 23, 2015

Last Updated

December 31, 2015

Sponsor

The Hong Kong Polytechnic University

1. Study Identification

Unique Protocol Identification Number

NCT02645331

Brief Title

"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

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemiplegic Cerebral Palsy, Upper Extremity Hemiplegia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Remind-to-move

Arm Type

Experimental

Arm Description

Arm Title

Modified constraint induced movement therapy (mCIMT)

Arm Type

Active Comparator

Arm Description

Arm Title

Conventional rehabilitation

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Remind-to-move

Intervention Type

Behavioral

Intervention Name(s)

Modified constraint induced movement therapy

Intervention Type

Behavioral

Intervention Name(s)

Conventional rehabilitation

Primary Outcome Measure Information:

Title

Jebsen-Taylor Hand Function Test (JTHFT)

Time Frame