Clinical trial NCT03838614: Gait and Muscle Power Training for Children With Developmental Coordination Disorder
Official title: Rhythmical Auditory Stimulation Gait Training and Muscle Power Training for Primary School Children With Developmental Coordination Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Coordination Disorder
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 76
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in spatiotemporal gait parameter - gait velocity (m/s)
timeFrame: 9 months
measure: Changes in spatiotemporal gait parameter - stride length (cm)
timeFrame: 9 months
measure: Changes in spatiotemporal gait parameter - cadence (steps/min)
timeFrame: 9 months
measure: Changes in spatiotemporal gait parameter - stance phase duration (% gait cycle)
timeFrame: 9 months
measure: Changes in spatiotemporal gait parameter - swing phase duration (% gait cycle)
timeFrame: 9 months
measure: Changes in spatiotemporal gait parameter - single-limb support durations (% gait cycle)
timeFrame: 9 months
measure: Changes in spatiotemporal gait parameter - double-limb support duration (% gait cycle)
timeFrame: 9 months
Secondary outcomes:
measure: Changes in kinematic gait parameters
timeFrame: 9 months
measure: Changes in leg muscle peak electromyographic values
timeFrame: 9 months
measure: Changes in leg muscle maximum strength
timeFrame: 9 months
measure: Changes in leg muscle force production time
timeFrame: 9 months
measure: Changes in self-reported falls
timeFrame: 9 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
References: