- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03598478
Tai Chi-muscle Power Training for Primary School Children With Developmental Coordination Disorder
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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)
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TC-MPT group
Tai Chi-muscle power training group
|
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.
|
ACTIVE_COMPARATOR: TC group
Tai Chi group
|
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.
|
ACTIVE_COMPARATOR: MPT group
Muscle power training group
|
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.
|
NO_INTERVENTION: Control group
Usual medical care is allowed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
0, 3, 6 months
|
Change of center of gravity control
Time Frame: 0, 3, 6 months
|
Computerized dynamic posturography - time to complete the DLOS test (sec)
|
0, 3, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of functional motor performance (raw data)
Time Frame: 0, 3, 6 months
|
Movement Assessment Battery for Children-2 total test score
|
0, 3, 6 months
|
Change of functional motor performance (compared to norm)
Time Frame: 0, 3, 6 months
|
Movement Assessment Battery for Children-2 total percentile rank (from 0-100 percentile).
A higher percentile represents better functional motor performance.
|
0, 3, 6 months
|
Change of leg muscle force production speed
Time Frame: 0, 3, 6 months
|
Isokinetic/ hand-held dynamometry: time taken to reach peak torque of the knee flexor and extensor muscles
|
0, 3, 6 months
|
Change of leg muscle strength
Time Frame: 0, 3, 6 months
|
Isokinetic/ hand-held dynamometry: peak torque of the knee flexor and extensor muscles
|
0, 3, 6 months
|
Change of fall history
Time Frame: 0, 3, 6 months
|
Self-reported and parent-reported falls
|
0, 3, 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 002 (University of CT Health Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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