Developmental Coordination DisorderNCT03598478
Tai Chi-muscle Power Training for Primary School Children With Developmental Coordination Disorder
A study testing TC-MPT, TC and 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 Tai Chi-muscle power training (TC-MPT), Tai Chi (TC) alone, muscle power training (MPT) alone, and usual care (as a control) for improving the limits of stability (LOS) of balance control in children with developmental coordination disorder (DCD) and to explore the… Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- TC-MPT, TC and MPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2020to 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 9- to 12-years-old
- Classified as DCD according to the Diagnostic and Statistical Manual of Mental Disorders V (DSM-5)
- A percentile score of < 5th percentile on the MABC-2
- A total score of < 55 (for children aged 8 to 9 years 11 months) or < 57 (for children aged 10 or above) on the DCD questionnaire 2007 (Chinese version)
- Attending a mainstream primary school (i.e., intelligence level within the normal range)
Who cannot join
- Any known significant congenital, cognitive, psychiatric (other than comorbid attention deficit hyperactivity disorder [ADHD] or autism spectrum disorder [ASD]), neurological, sensory, musculoskeletal, or cardiopulmonary disorder that may affect motor performance
- Receiving active treatment such as physiotherapy
- Demonstrating excessive disruptive behavior during the assessments
- Those unable to follow instructions properly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tai Chi-muscle Power Training for Primary School Children With Developmental Coordination Disorder: A Randomized Controlled Trial
Objectives: To compare the effectiveness of Tai Chi-muscle power training (TC-MPT), Tai Chi (TC) alone, muscle power training (MPT) alone, and usual care (as a control) for improving the limits of stability (LOS) of balance control in children with developmental coordination disorder (DCD) and to explore the relationship among LOS, falls, and functional performance in this population.
Design: A randomized controlled trial. Sample: 156 children with DCD. Interventions: TC-MPT, TC alone, MPT alone, or usual care for 12 weeks. Major outcomes: Outcomes will be evaluated at baseline, post-intervention, and a 3-month follow-up. An LOS test will give a dynamic LOS score, an isokinetic test will quantify leg muscle force production speed, Movement Assessment Battery for Children-2 will be used to assess functional motor performance, and fall history will be obtained via interviews.
Anticipated results and significance: The TC-MPT group is predicted to display the best LOS balance performance, which is associated with reduced fall incidents and improved functional performance. This novel training regime could be readily adopted into school or clinical settings to improve physical well-being in children with DCD, an outcome with positive socioeconomic implications.
Read the detailed description
Children with developmental coordination disorder (DCD), who comprise about 6% of the primary school population, display marked movement and balance difficulties. Reduced limits of stability (LOS), the maximum spatial area in which a standing person can lean, in these children is a major concern because it predisposes them to falls and affects their motor development.
The investigator's recent studies demonstrate the underlying causes of impaired LOS in children with DCD to include suboptimal volitional control of the center of gravity (COG) and reduced leg muscle force production speed. Tai chi (TC) is a particularly suitable exercise for improving COG control, yet the speed of movement is too slow to improve muscle power. Hence, muscle power training (MPT), which can hasten leg muscle force production, in conjunction with TC (TC-MPT) may be an ideal therapy for improving LOS, preventing falls, and improving functional performance in children with DCD.
In the proposed study, the investigators will pioneer the treatment of both COG control and leg muscular deficit in children with DCD by incorporating MPT into TC. It is hypothesized that the LOS of balance control in these children can best be improved by treating both their COG control and muscular deficits. This hypothesis is supported by the prediction that TC-MPT is superior to either TC or MPT alone in improving LOS balance performance. Furthermore, improved LOS is associated with fewer fall incidents and better functional performance in children with DCD.
Objectives: To compare the effectiveness of TC-MPT, TC alone, MPT alone, and usual care (as a control) for improving the LOS of balance control in children with DCD and to explore the relationship among LOS, falls, and functional performance in this population.
Design: A randomized controlled trial. Sample: 156 children with DCD. Interventions: TC-MPT, TC alone, MPT alone, or usual care for 12 weeks. Major outcomes: Outcomes will be evaluated at baseline, post-intervention, and a 3-month follow-up. An LOS test will give a dynamic LOS score, an isokinetic test will quantify leg muscle force production speed, Movement Assessment Battery for Children-2 will be used to assess functional motor performance, and fall history will be obtained via interviews.
Anticipated results and significance: The TC-MPT group is predicted to display the best LOS balance performance, which is associated with reduced fall incidents and improved functional performance. This novel training regime could be readily adopted into school or clinical settings to improve physical well-being in children with DCD, an outcome with positive socioeconomic implications.
- Conditions
- Developmental Coordination Disorder
- Being tested
- TC-MPT, TC, MPT
- 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.
TC-MPTBehavioural
Participants will receive two levels of training within each 90-minute session over a 12-week period: (1) TC training and (2) MPT. The TC training protocol consists of five basic TC movements. After receiving TC training, the participants in this group will take a 5-minute break and then receive MPT. During MPT, the participants will contract their major postural muscles bilaterally as fast as possible against a resistance equivalent to 70% of one repetition maximum.
TCBehavioural
Children in the TC group will skip the MPT session and practice TC movements repeatedly for 90 minutes. The exercise progression pattern in the TC-alone group will be the same as that in the TC-MPT group.
MPTBehavioural
Those children in the MPT group will perform strengthening exercises repeatedly for 90 minutes, with a short 5-minute break between the three sets of exercises if necessary. The exercise progression pattern in the MPT-alone group will be the same as that in the TC-MPT group.
| Study group | Role | What they receive |
|---|---|---|
| TC-MPT group | Experimental | Tai Chi-muscle power training group Receives: Behavioral: TC-MPT |
| TC group | Active comparator | Tai Chi group Receives: Behavioral: TC |
| MPT group | Active comparator | Muscle power training group Receives: Behavioral: MPT |
| Control group | No intervention | Usual medical care is allowed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of limits of stability
Computerized dynamic posturography - A dynamic limits of stability score (%), from 0-100%. A higher score represents a greater limits of stability (better).
Measured: 0, 3, 6 months
Change of center of gravity control
Computerized dynamic posturography - time to complete the DLOS test (sec)
Measured: 0, 3, 6 months
Secondary outcomes (5)
Change of functional motor performance (raw data)
Movement Assessment Battery for Children-2 total test score
Measured: 0, 3, 6 months
Change of functional motor performance (compared to norm)
Movement Assessment Battery for Children-2 total percentile rank (from 0-100 percentile). A higher percentile represents better functional motor performance.
Measured: 0, 3, 6 months
Change of leg muscle force production speed
Isokinetic/ hand-held dynamometry: time taken to reach peak torque of the knee flexor and extensor muscles
Measured: 0, 3, 6 months
Change of leg muscle strength
Isokinetic/ hand-held dynamometry: peak torque of the knee flexor and extensor muscles
Measured: 0, 3, 6 months
Change of fall history
Self-reported and parent-reported falls
Measured: 0, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jan 2020
- Primary completion31 Dec 2022 (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
- 156 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
- Investigators
- Shirley Fong, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598478
- Sponsor's protocol ID
- 002
- Status last verified
- Nov 2021
- First submitted
- 2 Jul 2018
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi-muscle Power Training for Primary School Children With Developmental Coordination Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03598478
- Acronym / sponsor ID
- 002
- Conditions
- Developmental Coordination Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Jul 2018 (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 Tai Chi-muscle power training (TC-MPT), Tai Chi (TC) alone, muscle power training (MPT) alone, and usual care (as a control) for improving the limits of stability (LOS) of balance control in children with developmental coordination disorder (DCD) and to explore the relationship among LOS, falls, and functional performance in this population.
Design: A randomized controlled trial. Sample: 156 children with DCD. Interventions: TC-MPT, TC alone, MPT alone, or usual care for 12 weeks. Major outcomes: Outcomes will be evaluated at baseline, post-intervention, and a 3-month follow-up. An LOS test will give a dynamic LOS score, an isokinetic test will quantify leg muscle force production speed, Movement Assessment Battery for Children-2 will be used to assess functional motor performance, and fall history will be obtained via interviews.
Anticipated results and significance: The TC-MPT group is predicted to display the best LOS balance performance, which is associated with reduced fall incidents and improved functional performance. This novel training regime could be readily adopted into school or clinical settings to improve physical well-being in children with DCD, an outcome with positive socioeconomic implications.
Detailed description
Children with developmental coordination disorder (DCD), who comprise about 6% of the primary school population, display marked movement and balance difficulties. Reduced limits of stability (LOS), the maximum spatial area in which a standing person can lean, in these children is a major concern because it predisposes them to falls and affects their motor development.
The investigator's recent studies demonstrate the underlying causes of impaired LOS in children with DCD to include suboptimal volitional control of the center of gravity (COG) and reduced leg muscle force production speed. Tai chi (TC) is a particularly suitable exercise for improving COG control, yet the speed of movement is too slow to improve muscle power. Hence, muscle power training (MPT), which can hasten leg muscle force production, in conjunction with TC (TC-MPT) may be an ideal therapy for improving LOS, preventing falls, and improving functional performance in children with DCD.
In the proposed study, the investigators will pioneer the treatment of both COG control and leg muscular deficit in children with DCD by incorporating MPT into TC. It is hypothesized that the LOS of balance control in these children can best be improved by treating both their COG control and muscular deficits. This hypothesis is supported by the prediction that TC-MPT is superior to either TC or MPT alone in improving LOS balance performance. Furthermore, improved LOS is associated with fewer fall incidents and better functional performance in children with DCD.
Objectives: To compare the effectiveness of TC-MPT, TC alone, MPT alone, and usual care (as a control) for improving the LOS of balance control in children with DCD and to explore the relationship among LOS, falls, and functional performance in this population.
Design: A randomized controlled trial. Sample: 156 children with DCD. Interventions: TC-MPT, TC alone, MPT alone, or usual care for 12 weeks. Major outcomes: Outcomes will be evaluated at baseline, post-intervention, and a 3-month follow-up. An LOS test will give a dynamic LOS score, an isokinetic test will quantify leg muscle force production speed, Movement Assessment Battery for Children-2 will be used to assess functional motor performance, and fall history will be obtained via interviews.
Anticipated results and significance: The TC-MPT group is predicted to display the best LOS balance performance, which is associated with reduced fall incidents and improved functional performance. This novel training regime could be readily adopted into school or clinical settings to improve physical well-being 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 |
|---|---|---|
| TC-MPT group | Experimental | Behavioral: TC-MPTTai Chi-muscle power training group |
| TC group | Active comparator | Behavioral: TCTai Chi group |
| MPT group | Active comparator | Behavioral: MPTMuscle power training group |
| Control group | No intervention | –Usual medical care is allowed. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 9- to 12-years-old
- Classified as DCD according to the Diagnostic and Statistical Manual of Mental Disorders V (DSM-5)
- A percentile score of < 5th percentile on the MABC-2
- A total score of < 55 (for children aged 8 to 9 years 11 months) or < 57 (for children aged 10 or above) on the DCD questionnaire 2007 (Chinese version)
- Attending a mainstream primary school (i.e., intelligence level within the normal range)
Key exclusion criteria (4 listed)
- Any known significant congenital, cognitive, psychiatric (other than comorbid attention deficit hyperactivity disorder [ADHD] or autism spectrum disorder [ASD]), neurological, sensory, musculoskeletal, or cardiopulmonary disorder that may affect motor performance
- Receiving active treatment such as physiotherapy
- Demonstrating excessive disruptive behavior during the assessments
- Those unable to follow instructions properly
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 |
|---|---|---|
| TC-MPTParticipants will receive two levels of training within each 90-minute session over a 12-week period: (1) TC training and (2) MPT. The TC training protocol consists of five basic TC movements. After receiving TC training, the participants in this group will take a 5-minute break and then receive MPT. During MPT, the participants will contract their major postural muscles bilaterally as fast as possible against a resistance equivalent to 70% of one repetition maximum. | Behavioural | TC-MPT group |
| TCChildren in the TC group will skip the MPT session and practice TC movements repeatedly for 90 minutes. The exercise progression pattern in the TC-alone group will be the same as that in the TC-MPT group. | Behavioural | TC group |
| MPTThose children in the MPT group will perform strengthening exercises repeatedly for 90 minutes, with a short 5-minute break between the three sets of exercises if necessary. The exercise progression pattern in the MPT-alone group will be the same as that in the TC-MPT group. | Behavioural | MPT group |
Primary outcome
Change of limits of stability
Time frame: 0, 3, 6 months
Computerized dynamic posturography - A dynamic limits of stability score (%), from 0-100%. A higher score represents a greater limits of stability (better).
Change of center of gravity control
Time frame: 0, 3, 6 months
Computerized dynamic posturography - time to complete the DLOS test (sec)
5 secondary outcomes
Change of functional motor performance (raw data)
Time frame: 0, 3, 6 months
Change of functional motor performance (compared to norm)
Time frame: 0, 3, 6 months
Change of leg muscle force production speed
Time frame: 0, 3, 6 months
Change of leg muscle strength
Time frame: 0, 3, 6 months
Change of fall history
Time frame: 0, 3, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- 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.
Shirley Fong, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TC-MPT, TC and 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 23 Nov 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of limits of stability (time frame: 0, 3, 6 months). The study lists 2 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 23 Nov 2021.