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Clinical Trials/NCT03838614
NCT03838614
Unknown
Not Applicable

Rhythmical Auditory Stimulation Gait Training and Muscle Power Training for Primary School Children With Developmental Coordination Disorder: A Randomized Controlled Trial

The University of Hong Kong1 site in 1 country76 target enrollmentJune 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Developmental Coordination Disorder
Sponsor
The University of Hong Kong
Enrollment
76
Locations
1
Primary Endpoint
Changes in spatiotemporal gait parameter - stride length (cm)
Last Updated
7 years ago

Overview

Brief Summary

Objectives: To compare the effectiveness of RAS-MPT, RAS alone, MPT alone, and usual care (as a control) for improving the overall gait performance of and reducing falls in children with developmental coordination disorder (DCD) and to explore the relationship between gait performance and falls in this population.

Design: A randomized controlled trial. Sample: 76 children with DCD. Interventions: RAS-MPT, RAS alone, MPT alone, or usual care (12 weeks). Major outcomes: Outcomes will be evaluated at baseline, post-intervention, and a 6-month follow-up. Comprehensive gait analysis will produce spatiotemporal gait parameters (e.g., velocity and stride length), kinematic gait parameters (e.g., knee joint motions), and leg muscle EMG outcomes; an isokinetic test will quantify leg muscle strength and force production time; and fall histories will be obtained via interviews. Anticipated results and significance: The RAS-MPT group is predicted to display the best gait performance, which is associated with reduced fall incidents. This novel training regime can be readily adopted in school, clinical, or home settings to improve locomotor ability in children with DCD, an outcome with positive socioeconomic implications.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
December 31, 2023
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shirley S.M. Fong

Principal Investigator

The University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • 6 to 9 years old
  • classified as DCD according to the Diagnostic and Statistical Manual of Mental Disorders V
  • \< 5th percentile on the Movement Assessment Battery for Children-2 (MABC-2)
  • a total score of \< 46 (for children aged 6 to 7 years 11 months) or \< 55 (for children aged 8 to 9 years) on the DCD questionnaire 2007 (Chinese version)
  • attending a mainstream school (i.e., intelligence level within the normal range).

Exclusion Criteria

  • any congenital, cognitive, psychiatric (e.g., comorbid attention deficit hyperactivity disorder or autism spectrum disorder), neurological, sensory, hearing, visual, vestibular, musculoskeletal, or cardiopulmonary disorder that may affect test performance
  • obesity (body mass index \[BMI\] \>95th percentile)
  • receiving active treatment such as physiotherapy
  • those unable to follow instructions.

Outcomes

Primary Outcomes

Changes in spatiotemporal gait parameter - stride length (cm)

Time Frame: 9 months

Changes in spatiotemporal gait parameter - cadence (steps/min)

Time Frame: 9 months

Changes in spatiotemporal gait parameter - stance phase duration (% gait cycle)

Time Frame: 9 months

Changes in spatiotemporal gait parameter - swing phase duration (% gait cycle)

Time Frame: 9 months

Changes in spatiotemporal gait parameter - single-limb support durations (% gait cycle)

Time Frame: 9 months

Changes in spatiotemporal gait parameter - double-limb support duration (% gait cycle)

Time Frame: 9 months

Changes in spatiotemporal gait parameter - gait velocity (m/s)

Time Frame: 9 months

Secondary Outcomes

  • Changes in kinematic gait parameters(9 months)
  • Changes in leg muscle peak electromyographic values(9 months)
  • Changes in leg muscle maximum strength(9 months)
  • Changes in leg muscle force production time(9 months)
  • Changes in self-reported falls(9 months)

Study Sites (1)

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