<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03838614</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <nct_id>NCT03838614</nct_id>
  </id_info>
  <brief_title>Gait and Muscle Power Training for Children With Developmental Coordination Disorder</brief_title>
  <official_title>Rhythmical Auditory Stimulation Gait Training and Muscle Power Training for Primary School Children With Developmental Coordination Disorder: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: To compare the effectiveness of RAS-MPT, RAS alone, MPT alone, and usual care (as&#xD;
      a control) for improving the overall gait performance of and reducing falls in children with&#xD;
      developmental coordination disorder (DCD) and to explore the relationship between gait&#xD;
      performance and falls in this population.&#xD;
&#xD;
      Design: A randomized controlled trial. Sample: 76 children with DCD. Interventions: RAS-MPT,&#xD;
      RAS alone, MPT alone, or usual care (12 weeks). Major outcomes: Outcomes will be evaluated at&#xD;
      baseline, post-intervention, and a 6-month follow-up. Comprehensive gait analysis will&#xD;
      produce spatiotemporal gait parameters (e.g., velocity and stride length), kinematic gait&#xD;
      parameters (e.g., knee joint motions), and leg muscle EMG outcomes; an isokinetic test will&#xD;
      quantify leg muscle strength and force production time; and fall histories will be obtained&#xD;
      via interviews. Anticipated results and significance: The RAS-MPT group is predicted to&#xD;
      display the best gait performance, which is associated with reduced fall incidents. This&#xD;
      novel training regime can be readily adopted in school, clinical, or home settings to improve&#xD;
      locomotor ability in children with DCD, an outcome with positive socioeconomic implications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in spatiotemporal gait parameter - gait velocity (m/s)</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in spatiotemporal gait parameter - stride length (cm)</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in spatiotemporal gait parameter - cadence (steps/min)</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in spatiotemporal gait parameter - stance phase duration (% gait cycle)</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in spatiotemporal gait parameter - swing phase duration (% gait cycle)</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in spatiotemporal gait parameter - single-limb support durations (% gait cycle)</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in spatiotemporal gait parameter - double-limb support duration (% gait cycle)</measure>
    <time_frame>9 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in kinematic gait parameters</measure>
    <time_frame>9 months</time_frame>
    <description>Maximum knee and ankle angles during different gait phases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in leg muscle peak electromyographic values</measure>
    <time_frame>9 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in leg muscle maximum strength</measure>
    <time_frame>9 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in leg muscle force production time</measure>
    <time_frame>9 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in self-reported falls</measure>
    <time_frame>9 months</time_frame>
    <description>Children and parents will report the number of falls within the study period.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">76</enrollment>
  <condition>Developmental Coordination Disorder</condition>
  <arm_group>
    <arm_group_label>RAS-MPT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rhythmical auditory stimulation gait training and muscle power training group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RAS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rhythmical auditory stimulation gait training group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MPT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Muscle power training group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Usual care group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT)</intervention_name>
    <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.</description>
    <arm_group_label>RAS-MPT group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Rhythmical auditory stimulation gait training (RAS)</intervention_name>
    <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.</description>
    <arm_group_label>RAS group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Muscle power training (MPT)</intervention_name>
    <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.</description>
    <arm_group_label>MPT group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Controls</intervention_name>
    <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.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  6 to 9 years old&#xD;
&#xD;
          -  classified as DCD according to the Diagnostic and Statistical Manual of Mental&#xD;
             Disorders V&#xD;
&#xD;
          -  &lt; 5th percentile on the Movement Assessment Battery for Children-2 (MABC-2)&#xD;
&#xD;
          -  a total score of &lt; 46 (for children aged 6 to 7 years 11 months) or &lt; 55 (for children&#xD;
             aged 8 to 9 years) on the DCD questionnaire 2007 (Chinese version)&#xD;
&#xD;
          -  attending a mainstream school (i.e., intelligence level within the normal range).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any congenital, cognitive, psychiatric (e.g., comorbid attention deficit hyperactivity&#xD;
             disorder or autism spectrum disorder), neurological, sensory, hearing, visual,&#xD;
             vestibular, musculoskeletal, or cardiopulmonary disorder that may affect test&#xD;
             performance&#xD;
&#xD;
          -  obesity (body mass index [BMI] &gt;95th percentile)&#xD;
&#xD;
          -  receiving active treatment such as physiotherapy&#xD;
&#xD;
          -  those unable to follow instructions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shirley Fong, PhD</last_name>
    <phone>28315260</phone>
    <email>smfong@hku.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Shirley S.M. Fong</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motor Skills Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03838614
org study id: 001
nct id: NCT03838614
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes in spatiotemporal gait parameter - gait velocity (m/s)
time frame: 9 months
measure: Changes in spatiotemporal gait parameter - stride length (cm)
time frame: 9 months
measure: Changes in spatiotemporal gait parameter - cadence (steps/min)
time frame: 9 months
measure: Changes in spatiotemporal gait parameter - stance phase duration (% gait cycle)
time frame: 9 months
measure: Changes in spatiotemporal gait parameter - swing phase duration (% gait cycle)
time frame: 9 months
measure: Changes in spatiotemporal gait parameter - single-limb support durations (% gait cycle)
time frame: 9 months
measure: Changes in spatiotemporal gait parameter - double-limb support duration (% gait cycle)
time frame: 9 months
measure: Changes in kinematic gait parameters
time frame: 9 months
description: Maximum knee and ankle angles during different gait phases
measure: Changes in leg muscle peak electromyographic values
time frame: 9 months
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
measure: Changes in leg muscle maximum strength
time frame: 9 months
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.
measure: Changes in leg muscle force production time
time frame: 9 months
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.
measure: Changes in self-reported falls
time frame: 9 months
description: Children and parents will report the number of falls within the study period.
arm group label: RAS-MPT group
arm group type: Experimental
description: Rhythmical auditory stimulation gait training and muscle power training group
arm group label: RAS group
arm group type: Experimental
description: Rhythmical auditory stimulation gait training group
arm group label: MPT group
arm group type: Experimental
description: Muscle power training group
arm group label: Control group
arm group type: Other
description: Usual care group
intervention type: Behavioral
intervention name: Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT)
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.
arm group label: RAS-MPT group
intervention type: Behavioral
intervention name: Rhythmical auditory stimulation gait training (RAS)
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.
arm group label: RAS group
intervention type: Behavioral
intervention name: Muscle power training (MPT)
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.
arm group label: MPT group
intervention type: Other
intervention name: Controls
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.
arm group label: Control group
criteria: 
gender: All
minimum age: 6 Years
maximum age: 9 Years
healthy volunteers: No
last name: Shirley Fong, PhD
phone: 28315260
email: smfong@hku.hk
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Shirley S.M. Fong
investigator title: Principal Investigator
mesh term: Motor Skills Disorders
sharing ipd: Undecided