Gait and Muscle Power Training for Children With Developmental Coordination Disorder
Primary Purpose
Developmental Coordination Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT)
Rhythmical auditory stimulation gait training (RAS)
Muscle power training (MPT)
Controls
Sponsored by
About this trial
This is an interventional treatment trial for Developmental Coordination Disorder
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.
Sites / Locations
- University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Other
Arm Label
RAS-MPT group
RAS group
MPT group
Control group
Arm Description
Rhythmical auditory stimulation gait training and muscle power training group
Rhythmical auditory stimulation gait training group
Muscle power training group
Usual care group
Outcomes
Primary Outcome Measures
Changes in spatiotemporal gait parameter - gait velocity (m/s)
Changes in spatiotemporal gait parameter - stride length (cm)
Changes in spatiotemporal gait parameter - cadence (steps/min)
Changes in spatiotemporal gait parameter - stance phase duration (% gait cycle)
Changes in spatiotemporal gait parameter - swing phase duration (% gait cycle)
Changes in spatiotemporal gait parameter - single-limb support durations (% gait cycle)
Changes in spatiotemporal gait parameter - double-limb support duration (% gait cycle)
Secondary Outcome Measures
Changes in kinematic gait parameters
Maximum knee and ankle angles during different gait phases
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
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.
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.
Changes in self-reported falls
Children and parents will report the number of falls within the study period.
Full Information
NCT ID
NCT03838614
First Posted
February 6, 2019
Last Updated
February 8, 2019
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03838614
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Coordination Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RAS-MPT group
Arm Type
Experimental
Arm Description
Rhythmical auditory stimulation gait training and muscle power training group
Arm Title
RAS group
Arm Type
Experimental
Arm Description
Rhythmical auditory stimulation gait training group
Arm Title
MPT group
Arm Type
Experimental
Arm Description
Muscle power training group
Arm Title
Control group
Arm Type
Other
Arm Description
Usual care group
Intervention Type
Behavioral
Intervention Name(s)
Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT)
Intervention Description
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
Intervention Name(s)
Rhythmical auditory stimulation gait training (RAS)
Intervention Description
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
Intervention Name(s)
Muscle power training (MPT)
Intervention Description
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
Other
Intervention Name(s)
Controls
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in spatiotemporal gait parameter - gait velocity (m/s)
Time Frame
9 months
Title
Changes in spatiotemporal gait parameter - stride length (cm)
Time Frame
9 months
Title
Changes in spatiotemporal gait parameter - cadence (steps/min)
Time Frame
9 months
Title
Changes in spatiotemporal gait parameter - stance phase duration (% gait cycle)
Time Frame
9 months
Title
Changes in spatiotemporal gait parameter - swing phase duration (% gait cycle)
Time Frame
9 months
Title
Changes in spatiotemporal gait parameter - single-limb support durations (% gait cycle)
Time Frame
9 months
Title
Changes in spatiotemporal gait parameter - double-limb support duration (% gait cycle)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Changes in kinematic gait parameters
Description
Maximum knee and ankle angles during different gait phases
Time Frame
9 months
Title
Changes in leg muscle peak electromyographic values
Description
Changes in leg muscle peak electromyographic values (in % of maximal voluntary isometric contraction) of rectus femoris, biceps femoris, tibialis anterior, and gastrocnemius medialis muscles
Time Frame
9 months
Title
Changes in leg muscle maximum strength
Description
Changes in maximum muscle strength of knee extensors and flexors and ankle plantar flexors and dorsiflexors of the dominant leg as measured by dynamometry.
Time Frame
9 months
Title
Changes in leg muscle force production time
Description
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.
Time Frame
9 months
Title
Changes in self-reported falls
Description
Children and parents will report the number of falls within the study period.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shirley Fong, PhD
Phone
28315260
Email
smfong@hku.hk
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Gait and Muscle Power Training for Children With Developmental Coordination Disorder
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