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

Primary Purpose

Developmental Coordination Disorder

Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
TC-MPT
TC
MPT
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Coordination Disorder

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

No Intervention

Arm Label

TC-MPT group

TC group

MPT group

Control group

Arm Description

Tai Chi-muscle power training group

Tai Chi group

Muscle power training group

Usual medical care is allowed.

Outcomes

Primary Outcome Measures

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).
Change of center of gravity control
Computerized dynamic posturography - time to complete the DLOS test (sec)

Secondary Outcome Measures

Change of functional motor performance (raw data)
Movement Assessment Battery for Children-2 total test score
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.
Change of leg muscle force production speed
Isokinetic/ hand-held dynamometry: time taken to reach peak torque of the knee flexor and extensor muscles
Change of leg muscle strength
Isokinetic/ hand-held dynamometry: peak torque of the knee flexor and extensor muscles
Change of fall history
Self-reported and parent-reported falls

Full Information

First Posted
July 2, 2018
Last Updated
November 20, 2021
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03598478
Brief Title
Tai Chi-muscle Power Training for Primary School Children With Developmental Coordination Disorder
Official Title
Tai Chi-muscle Power Training for Primary School Children With Developmental Coordination Disorder: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Coordination Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TC-MPT group
Arm Type
Experimental
Arm Description
Tai Chi-muscle power training group
Arm Title
TC group
Arm Type
Active Comparator
Arm Description
Tai Chi group
Arm Title
MPT group
Arm Type
Active Comparator
Arm Description
Muscle power training group
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual medical care is allowed.
Intervention Type
Behavioral
Intervention Name(s)
TC-MPT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TC
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MPT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of limits of stability
Description
Computerized dynamic posturography - A dynamic limits of stability score (%), from 0-100%. A higher score represents a greater limits of stability (better).
Time Frame
0, 3, 6 months
Title
Change of center of gravity control
Description
Computerized dynamic posturography - time to complete the DLOS test (sec)
Time Frame
0, 3, 6 months
Secondary Outcome Measure Information:
Title
Change of functional motor performance (raw data)
Description
Movement Assessment Battery for Children-2 total test score
Time Frame
0, 3, 6 months
Title
Change of functional motor performance (compared to norm)
Description
Movement Assessment Battery for Children-2 total percentile rank (from 0-100 percentile). A higher percentile represents better functional motor performance.
Time Frame
0, 3, 6 months
Title
Change of leg muscle force production speed
Description
Isokinetic/ hand-held dynamometry: time taken to reach peak torque of the knee flexor and extensor muscles
Time Frame
0, 3, 6 months
Title
Change of leg muscle strength
Description
Isokinetic/ hand-held dynamometry: peak torque of the knee flexor and extensor muscles
Time Frame
0, 3, 6 months
Title
Change of fall history
Description
Self-reported and parent-reported falls
Time Frame
0, 3, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley Fong, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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