Gait and Muscle Power Training for Children With Developmental Coordination Disorder

NCT ID: NCT03838614

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RAS-MPT group

Rhythmical auditory stimulation gait training and muscle power training group

Group Type: EXPERIMENTAL

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

Intervention Type: 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 group

Rhythmical auditory stimulation gait training group

Group Type: EXPERIMENTAL

Rhythmical auditory stimulation gait training (RAS)

Intervention Type: 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.

MPT group

Muscle power training group

Group Type: EXPERIMENTAL

Muscle power training (MPT)

Intervention Type: 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.

Control group

Usual care group

Group Type: OTHER

Controls

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Shirley S.M. Fong

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Central Contacts

Shirley Fong, PhD

Role: CONTACT

smfong@hku.hk

28315260

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id