Gait and Muscle Power Training for Children With Developmental Coordination Disorder

Sponsor
The University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03838614
Collaborator
(none)
76
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55
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Changes in spatiotemporal gait parameter - gait velocity (m/s) [9 months]

  2. Changes in spatiotemporal gait parameter - stride length (cm) [9 months]

  3. Changes in spatiotemporal gait parameter - cadence (steps/min) [9 months]

  4. Changes in spatiotemporal gait parameter - stance phase duration (% gait cycle) [9 months]

  5. Changes in spatiotemporal gait parameter - swing phase duration (% gait cycle) [9 months]

  6. Changes in spatiotemporal gait parameter - single-limb support durations (% gait cycle) [9 months]

  7. Changes in spatiotemporal gait parameter - double-limb support duration (% gait cycle) [9 months]

Secondary Outcome Measures

  1. Changes in kinematic gait parameters [9 months]

    Maximum knee and ankle angles during different gait phases

  2. Changes in leg muscle peak electromyographic values [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 [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 [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 [9 months]

    Children and parents will report the number of falls within the study period.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shirley S.M. Fong, Principal Investigator, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT03838614
Other Study ID Numbers:
  • 001
First Posted:
Feb 12, 2019
Last Update Posted:
Feb 12, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 12, 2019