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Completed

NCT Number: NCT02645331

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

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.

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Key information

Conditions

Hemiplegic Cerebral Palsy Upper Extremity Hemiplegia

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remind-to-move

Behavioral

Modified Constraint Induced Movement Therapy

Behavioral

Conventional rehabilitation

Behavioral

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Caregiver Functional Use Survey (CFUS)

    Time frame: Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)

  2. 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)

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 1, 2016
Registry last updated
Jan 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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