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Tai Chi-muscle Power Training for Primary School Children With Developmental Coordination Disorder

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ClinicalTrials.gov Identifier: NCT03598478
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Shirley S.M. Fong, The University of Hong Kong

Brief 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 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.


Condition or disease Intervention/treatment Phase
Developmental Coordination Disorder Behavioral: TC-MPT Behavioral: TC Behavioral: MPT Not Applicable

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.

Our 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, we will pioneer the treatment of both COG control and leg muscular deficit in children with DCD by incorporating MPT into TC. We hypothesize 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tai Chi-muscle Power Training for Primary School Children With Developmental Coordination Disorder: A Randomized Controlled Trial
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: TC-MPT group
Tai Chi-muscle power training group
Behavioral: TC-MPT
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
Behavioral: TC
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
Behavioral: MPT
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.



Primary Outcome Measures :
  1. Change of limits of stability [ Time Frame: 0, 3, 6 months ]
    Computerized dynamic posturography - A dynamic limits of stability (DLOS) score (%)

  2. Change of center of gravity control [ Time Frame: 0, 3, 6 months ]
    Computerized dynamic posturography - time to complete the DLOS test (sec)


Secondary Outcome Measures :
  1. Change of functional motor performance (raw data) [ Time Frame: 0, 3, 6 months ]
    Movement Assessment Battery for Children‒2 total test score

  2. Change of functional motor performance (compared to norm) [ Time Frame: 0, 3, 6 months ]
    Movement Assessment Battery for Children‒2 total percentile rank

  3. 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

  4. Change of leg muscle strength [ Time Frame: 0, 3, 6 months ]
    Isokinetic/ hand-held dynamometry: peak torque of the knee flexor and extensor muscles

  5. Change of fall history [ Time Frame: 0, 3, 6 months ]
    Self-reported and parent-reported falls



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Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598478


Contacts
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Contact: Shirley Fong, PhD 85297090337 smfong@hku.hk

Locations
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Hong Kong
University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Shirley SM Fong, PT, PhD    852-97090337    smfong@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Shirley Fong, PhD The University of Hong Kong

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Responsible Party: Shirley S.M. Fong, Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03598478     History of Changes
Other Study ID Numbers: 002
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Motor Skills Disorders
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders