Developmental Coordination DisorderNCT03838614
Gait and Muscle Power Training for Children With Developmental Coordination Disorder
A study testing Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT), Rhythmical auditory stimulation gait training (RAS) and Muscle power training (MPT) in people with Developmental Coordination Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT), Rhythmical auditory stimulation gait training (RAS) and Muscle power training (MPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rhythmical Auditory Stimulation Gait Training and Muscle Power Training for Primary School Children With Developmental Coordination Disorder: A Randomized Controlled Trial
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
- Being tested
- Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT), Rhythmical auditory stimulation gait training (RAS), Muscle power training (MPT), Controls
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT)Behavioural
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.
Rhythmical auditory stimulation gait training (RAS)Behavioural
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.
Muscle power training (MPT)Behavioural
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.
ControlsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| RAS-MPT group | Experimental | Rhythmical auditory stimulation gait training and muscle power training group Receives: Behavioral: Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT) |
| RAS group | Experimental | Rhythmical auditory stimulation gait training group Receives: Behavioral: Rhythmical auditory stimulation gait training (RAS) |
| MPT group | Experimental | Muscle power training group Receives: Behavioral: Muscle power training (MPT) |
| Control group | Other | Usual care group Receives: Other: Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in spatiotemporal gait parameter - gait velocity (m/s)
Measured: 9 months
Changes in spatiotemporal gait parameter - stride length (cm)
Measured: 9 months
Changes in spatiotemporal gait parameter - cadence (steps/min)
Measured: 9 months
Changes in spatiotemporal gait parameter - stance phase duration (% gait cycle)
Measured: 9 months
Changes in spatiotemporal gait parameter - swing phase duration (% gait cycle)
Measured: 9 months
Changes in spatiotemporal gait parameter - single-limb support durations (% gait cycle)
Measured: 9 months
Changes in spatiotemporal gait parameter - double-limb support duration (% gait cycle)
Measured: 9 months
Secondary outcomes (5)
Changes in kinematic gait parameters
Maximum knee and ankle angles during different gait phases
Measured: 9 months
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
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
Changes in self-reported falls
Children and parents will report the number of falls within the study period.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start1 Jun 2019 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Coordination DisorderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley S.M. Fong, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838614
- Sponsor's protocol ID
- 001
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhythmical Auditory Stimulation Gait Training and Muscle Power Training for Primary School Children With Developmental Coordination Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03838614
- Acronym / sponsor ID
- 001
- Conditions
- Developmental Coordination Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RAS-MPT group | Experimental | Behavioral: Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT)Rhythmical auditory stimulation gait training and muscle power training group |
| RAS group | Experimental | Behavioral: Rhythmical auditory stimulation gait training (RAS)Rhythmical auditory stimulation gait training group |
| MPT group | Experimental | Behavioral: Muscle power training (MPT)Muscle power training group |
| Control group | Other | Other: ControlsUsual care group |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | RAS-MPT group |
| 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. | Behavioural | RAS group |
| 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. | Behavioural | MPT group |
| ControlsParticipants 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. | Other | Control group |
Primary outcome
Changes in spatiotemporal gait parameter - gait velocity (m/s)
Time frame: 9 months
Changes in spatiotemporal gait parameter - stride length (cm)
Time frame: 9 months
Changes in spatiotemporal gait parameter - cadence (steps/min)
Time frame: 9 months
Changes in spatiotemporal gait parameter - stance phase duration (% gait cycle)
Time frame: 9 months
Changes in spatiotemporal gait parameter - swing phase duration (% gait cycle)
Time frame: 9 months
Changes in spatiotemporal gait parameter - single-limb support durations (% gait cycle)
Time frame: 9 months
Changes in spatiotemporal gait parameter - double-limb support duration (% gait cycle)
Time frame: 9 months
5 secondary outcomes
Changes in kinematic gait parameters
Time frame: 9 months
Changes in leg muscle peak electromyographic values
Time frame: 9 months
Changes in leg muscle maximum strength
Time frame: 9 months
Changes in leg muscle force production time
Time frame: 9 months
Changes in self-reported falls
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT), Rhythmical auditory stimulation gait training (RAS) and Muscle power training (MPT) in people with Developmental Coordination Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shirley Fong, PhD (28315260, smfong@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in spatiotemporal gait parameter - gait velocity (m/s) (time frame: 9 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.