- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02635711
Taekwondo for Children With Developmental Coordination Disorder
A Randomised Controlled Trial of the Effectiveness of Adapted Taekwondo Training on Skeletal Development and Motor Proficiency in Pre-pubertal Children With Developmental Coordination Disorder
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Expected results: Based on the results of our pilot study, the investigators expect that the subjects in the adapted TKD group will have improved skeletal development and motor proficiency outcomes after TKD training compared with the controls.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pokfulam, Hong Kong
- Recruiting
- University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adapted Taekwondo training
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.
|
Adapted Taekwondo training for beginners
|
Active Comparator: Control
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.
|
Daily jogging
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in delay in skeletal development: ultrasonic bone age measurement
Time Frame: Change from baseline to 3 and 6 months
|
Change from baseline to 3 and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in eye-hand coordination: finger pointing test
Time Frame: Change from baseline to 3 and 6 months
|
Change from baseline to 3 and 6 months
|
Change in standing balance: Sensory Organisation Test
Time Frame: Change from baseline to 3 and 6 months
|
Change from baseline to 3 and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shirley SM Fong, PhD, The University of Hong Kong
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01 (Miami VAHS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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