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Gait and Muscle Power Training for Children With Developmental Coordination Disorder

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ClinicalTrials.gov Identifier: NCT03838614
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Shirley S.M. Fong, The University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Developmental Coordination Disorder 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rhythmical Auditory Stimulation Gait Training and Muscle Power Training for Primary School Children With Developmental Coordination Disorder: A Randomized Controlled Trial
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: RAS-MPT group
Rhythmical auditory stimulation gait training and muscle power training group
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.

Experimental: RAS group
Rhythmical auditory stimulation gait training group
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.

Experimental: MPT group
Muscle power training group
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.

Control group
Usual care group
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.




Primary Outcome Measures :
  1. Changes in spatiotemporal gait parameter - gait velocity (m/s) [ Time Frame: 9 months ]
  2. Changes in spatiotemporal gait parameter - stride length (cm) [ Time Frame: 9 months ]
  3. Changes in spatiotemporal gait parameter - cadence (steps/min) [ Time Frame: 9 months ]
  4. Changes in spatiotemporal gait parameter - stance phase duration (% gait cycle) [ Time Frame: 9 months ]
  5. Changes in spatiotemporal gait parameter - swing phase duration (% gait cycle) [ Time Frame: 9 months ]
  6. Changes in spatiotemporal gait parameter - single-limb support durations (% gait cycle) [ Time Frame: 9 months ]
  7. Changes in spatiotemporal gait parameter - double-limb support duration (% gait cycle) [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Changes in kinematic gait parameters [ Time Frame: 9 months ]
    Maximum knee and ankle angles during different gait phases

  2. Changes in leg muscle peak electromyographic values [ Time Frame: 9 months ]
    Changes in leg muscle peak electromyographic values (in % of maximal voluntary isometric contraction) of rectus femoris, biceps femoris, tibialis anterior, and gastrocnemius medialis muscles

  3. Changes in leg muscle maximum strength [ Time Frame: 9 months ]
    Changes in maximum muscle strength of knee extensors and flexors and ankle plantar flexors and dorsiflexors of the dominant leg as measured by dynamometry.

  4. Changes in leg muscle force production time [ Time Frame: 9 months ]
    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.

  5. Changes in self-reported falls [ Time Frame: 9 months ]
    Children and parents will report the number of falls within the study period.



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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838614


Contacts
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Contact: Shirley Fong, PhD 28315260 smfong@hku.hk

Locations
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Hong Kong
University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong

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Responsible Party: Shirley S.M. Fong, Principal Investigator, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03838614     History of Changes
Other Study ID Numbers: 001
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Motor Skills Disorders
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders