Gait and Muscle Power Training for Children With Developmental Coordination Disorder

NCT03838614 | Unknown DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Coordination Disorder

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• 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 Arms (4)

RAS-MPT group

EXPERIMENTAL

Rhythmical auditory stimulation gait training and muscle power training group

Behavioral: Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT)

RAS group

EXPERIMENTAL

Rhythmical auditory stimulation gait training group

Behavioral: Rhythmical auditory stimulation gait training (RAS)

MPT group

EXPERIMENTAL

Muscle power training group

Behavioral: Muscle power training (MPT)

Control group

OTHER

Usual care group

Other: Controls

Interventions

Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT) BEHAVIORAL

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.

RAS-MPT group

Rhythmical auditory stimulation gait training (RAS) BEHAVIORAL

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.

RAS group

Muscle power training (MPT) BEHAVIORAL

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.

MPT group

Controls OTHER

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.

Control group

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Shirley Fong, PhD

CONTACT

28315260; smfong@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 12, 2019
• Study Start: June 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 12, 2019

Record last verified: 2019-02

Locations

HK (1)