Gait and Muscle Power Training for Children With Developmental Coordination Disorder

Developmental Coordination Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03838614
• Other study ID #: 001
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2019
• Source: The University of Hong Kong
• Contact: Shirley Fong, PhD
• Phone: 28315260
• Email: smfong[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ataxia
• Developmental Coordination Disorder
• Disease
• Motor Skills Disorders

Intervention

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.
• 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.
• 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:
• 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.

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in spatiotemporal gait parameter - gait velocity (m/s)		9 months
Primary	Changes in spatiotemporal gait parameter - stride length (cm)		9 months
Primary	Changes in spatiotemporal gait parameter - cadence (steps/min)		9 months
Primary	Changes in spatiotemporal gait parameter - stance phase duration (% gait cycle)		9 months
Primary	Changes in spatiotemporal gait parameter - swing phase duration (% gait cycle)		9 months
Primary	Changes in spatiotemporal gait parameter - single-limb support durations (% gait cycle)		9 months
Primary	Changes in spatiotemporal gait parameter - double-limb support duration (% gait cycle)		9 months
Secondary	Changes in kinematic gait parameters	Maximum knee and ankle angles during different gait phases	9 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in self-reported falls	Children and parents will report the number of falls within the study period.	9 months