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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02635711
Other study ID # 01
Secondary ID
Status Recruiting
Phase N/A
First received December 13, 2015
Last updated December 16, 2015
Start date December 2015
Est. completion date December 2019

Study information

Verified date December 2015
Source The University of Hong Kong
Contact Shirley SM Fong, PhD
Phone +85297090337
Email smfong@hku.hk
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 104
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 9 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Adapted Taekwondo training
Adapted Taekwondo training for beginners
Control
Daily jogging

Locations

Country Name City State
Hong Kong University of Hong Kong Pokfulam

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in delay in skeletal development: ultrasonic bone age measurement Change from baseline to 3 and 6 months No
Secondary Change in eye-hand coordination: finger pointing test Change from baseline to 3 and 6 months No
Secondary Change in standing balance: Sensory Organisation Test Change from baseline to 3 and 6 months No
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