NCT03598478

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

3 years

First QC Date

July 2, 2018

Last Update Submit

November 20, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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).

    0, 3, 6 months

  • Change of center of gravity control

    Computerized dynamic posturography - time to complete the DLOS test (sec)

    0, 3, 6 months

Secondary Outcomes (5)

  • Change of functional motor performance (raw data)

    0, 3, 6 months

  • Change of functional motor performance (compared to norm)

    0, 3, 6 months

  • Change of leg muscle force production speed

    0, 3, 6 months

  • Change of leg muscle strength

    0, 3, 6 months

  • Change of fall history

    0, 3, 6 months

Study Arms (4)

TC-MPT group

EXPERIMENTAL

Tai Chi-muscle power training group

Behavioral: TC-MPT

TC group

ACTIVE COMPARATOR

Tai Chi group

Behavioral: TC

MPT group

ACTIVE COMPARATOR

Muscle power training group

Behavioral: MPT

Control group

NO INTERVENTION

Usual medical care is allowed.

Interventions

TC-MPTBEHAVIORAL

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.

TC-MPT group
TCBEHAVIORAL

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.

TC group
MPTBEHAVIORAL

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.

MPT group

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Shirley Fong, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 26, 2018

Study Start

January 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations