Gait and Muscle Power Training for Children With Developmental Coordination Disorder

Study Overview
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Brief Summary
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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.

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

Conditions
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Developmental Coordination Disorder

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAS-MPT group<br>Rhythmical auditory stimulation gait training and muscle power training group | Behavioral: Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT)<br>* 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.<br>|
| Experimental: RAS group<br>Rhythmical auditory stimulation gait training group | Behavioral: Rhythmical auditory stimulation gait training (RAS)<br>* 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.<br>|
| Experimental: MPT group<br>Muscle power training group | Behavioral: Muscle power training (MPT)<br>* 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.<br>|
| Other: Control group<br>Usual care group | Other: Controls<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |