Gait and Muscle Power Training for Children With Developmental Coordination Disorder

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Developmental Coordination Disorder
• Intervention / Treatment: Behavioral: Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT); Behavioral: Rhythmical auditory stimulation gait training (RAS); Behavioral: Muscle power training (MPT); Other: Controls

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shirley Fong, PhD; Phone Number: 28315260; Email: smfong@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RAS-MPT group; Rhythmical auditory stimulation gait training and muscle power training group	Behavioral: Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT); The RAS-MPT group will attend a 60-minute training session once a week and home exercises (twice/week) for 12 weeks. Participants will receive two levels of training within each 60-minute session: (1) RAS-treadmill training and (2) MPT.
Experimental: RAS group; Rhythmical auditory stimulation gait training group	Behavioral: Rhythmical auditory stimulation gait training (RAS); The RAS group will attend a 60-minute training session once a week and home exercises (twice/week) for 12 weeks. Participants will receive RAS-treadmill training repeatedly within each 60-minute session.
Experimental: MPT group; Muscle power training group	Behavioral: Muscle power training (MPT); The MPT group will attend a 60-minute training session once a week and home exercises (twice/week) for 12 weeks. Participants will receive muscle power training repeatedly within each 60-minute session.
Other: Control group; Usual care group	Other: Controls; Participants in the control group will receive no intervention during the study period, but continue with their normal daily activities and usual medical care. They will receive the same training as the RAS-MPT group after the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in spatiotemporal gait parameter - gait velocity (m/s)	9 months
Changes in spatiotemporal gait parameter - stride length (cm)	9 months
Changes in spatiotemporal gait parameter - cadence (steps/min)	9 months
Changes in spatiotemporal gait parameter - stance phase duration (% gait cycle)	9 months
Changes in spatiotemporal gait parameter - swing phase duration (% gait cycle)	9 months
Changes in spatiotemporal gait parameter - single-limb support durations (% gait cycle)	9 months
Changes in spatiotemporal gait parameter - double-limb support duration (% gait cycle)	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in kinematic gait parameters	Maximum knee and ankle angles during different gait phases	9 months
Changes in leg muscle peak electromyographic values	Changes in leg muscle peak electromyographic values (in % of maximal voluntary isometric contraction) of rectus femoris, biceps femoris, tibialis anterior, and gastrocnemius medialis muscles	9 months
Changes in leg muscle maximum strength	Changes in maximum muscle strength of knee extensors and flexors and ankle plantar flexors and dorsiflexors of the dominant leg as measured by dynamometry.	9 months
Changes in leg muscle force production time	Changes in muscle force production time of knee extensors and flexors and ankle plantar flexors and dorsiflexors of the dominant leg as measured by dynamometry.	9 months
Changes in self-reported falls	Children and parents will report the number of falls within the study period.	9 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Motor Skills Disorders
• Other Study ID Numbers: 001 (NavyGHB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No