NCT02635711

Brief Summary

Objectives: To evaluate the effects of a novel adapted Taekwondo (TKD) training programme on skeletal development and motor proficiency in pre-pubertal children with developmental coordination disorder (DCD). Hypothesis: The TKD group participants will have improved skeletal development and motor proficiency outcomes after adapted TKD training compared with the controls. Design and subjects: In this prospective, randomised, single-blinded controlled trial, approximately 104 children with DCD (6-9 years old) will be randomly assigned to either the adapted TKD group (n\~52) or the control group (n\~52). Interventions: Subjects in the intervention group will receive adapted TKD training for 3 months (one supervised session/week plus daily home training, 1 hour per session), while subjects in the control group will receive no TKD training during the study period. Study instruments and outcomes: Primary outcome measures: delay in skeletal development and motor proficiency will be measured by an ultrasonic bone age system and the Movement Assessment Battery for Children, respectively. Secondary outcome measures: eye-hand coordination and standing balance will be measured by a computerised finger pointing test and the Sensory Organisation Test, respectively (pre-, post- and follow-up measurements). Data analysis: Data will be analysed via repeated-measure analysis of (co)variance followed by post-hoc tests, if appropriate (alpha = 0.05).

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
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

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

Study Start

First participant enrolled

December 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 21, 2015

Status Verified

December 1, 2015

Enrollment Period

4 years

First QC Date

December 13, 2015

Last Update Submit

December 16, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in delay in skeletal development: ultrasonic bone age measurement

    Change from baseline to 3 and 6 months

Secondary Outcomes (2)

  • Change in eye-hand coordination: finger pointing test

    Change from baseline to 3 and 6 months

  • Change in standing balance: Sensory Organisation Test

    Change from baseline to 3 and 6 months

Study Arms (2)

Adapted Taekwondo training

EXPERIMENTAL

An adapted TKD training regime which was developed by our research team \[16\] will be used in this study. This training programme is designed to train balance control, eye-hand coordination and facilitate skeletal development for children with DCD. The high-impact striking techniques (e.g., punching and blocking) incorporated in the programme may stimulate bone growth \[15\]. Subjects who are assigned to the TKD training group will attend a weekly 1-h session of TKD training that will be held at the University of Hong Kong for 12 weeks. All TKD training sessions will be conducted by a qualified World Taekwondo Federation black belt coach.

Behavioral: Adapted Taekwondo training

Control

ACTIVE COMPARATOR

Subjects who are assigned to the DCD-control group will receive no TKD training during the study period. Instead, they will participate in jogging exercise daily (one hour per day) for 12 weeks. Participants will be encouraged to jog to school or other places every day, as appropriate. Pedometers will be used to monitor their exercise level and enhance habitual physical activity. The pedometer count (steps per day) will be documented in a log book by the parents. Signed log books will be returned to our research personnel after the intervention period. In addition, children with DCD in this group will receive an adapted TKD training menu and 12 training/demonstration sessions immediately after the follow-up testing is completed.

Behavioral: Control

Interventions

Adapted Taekwondo training for beginners

Adapted Taekwondo training
ControlBEHAVIORAL

Daily jogging

Control

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Between 6 and 9 years of age
  • In Tanner stage I (i.e., pre-pubertal - no pubic hair; boys: testicular volume \<1.5 mL as measured by the water displacement test and small penis of \<3 cm; girls: no glandular tissue/breasts not developed) as reported by the parents using sexual maturity diagrams \[9\]
  • Diagnosed with DCD based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR or DSM-V) \[1\]
  • A Bruininks-Oseretsky Test of Motor Proficiency gross motor composite score of ≤42 \[17\]; (5) attending a local mainstream primary school
  • Normal intelligence
  • Able to follow instructions
  • No experience in TKD or other martial arts.

You may not qualify if:

  • Diagnosed with neurological or other movement disorders
  • Diagnosed with psychiatric, congenital, sensory, musculoskeletal or cardiopulmonary disorders that can affect motor performance or skeletal development
  • Receiving active treatment, including complementary and alternative medicine
  • Demonstrating excessive disruptive behaviour.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Pokfulam, Hong Kong

RECRUITING

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Shirley SM Fong, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirley SM Fong, PhD

CONTACT

Shirley SM Fong, PhD

CONTACT

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
Dr

Study Record Dates

First Submitted

December 13, 2015

First Posted

December 21, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 21, 2015

Record last verified: 2015-12

Locations