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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04123912
Other study ID # 0001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2022

Study information

Verified date October 2019
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim: To investigate the effectiveness of a novel elastic taping-augmented functional movement power training (KT-FMPT) program in improving leg muscular performance, body balance, motor proficiency and functional independence in children with developmental coordination disorder (DCD).

Methodology: In this clinical trial, twenty children with DCD (aged 6-12) will be randomly assigned to either a KT-FMPT group or a placebo control group. Children in the KT-FMPT and control groups will receive elastic taping-augmented FMPT and general jogging exercise with non-elastic taping, respectively, for 12 weeks (2 hours/week). Major outcome measures: body balance and leg muscle activity will be measured via muscle sensors along with a force platform. Secondary outcome measures: leg muscle strength, motor proficiency and functional independence will be assessed by a digital dynamometer, the Movement Assessment Battery for Children-2 and Pediatric Evaluation of Disability Inventory, respectively (before- and after-intervention measurements).

Significance: The KT-FMPT group is predicted to display much better muscular and motor performances than the control group. This novel training program can be readily adopted in clinical, school, or home settings to improve functional independence in children with DCD, an outcome with positive socioeconomic implications. Moreover, study findings will inspire future research work in children with other childhood-onset disabilities.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria:

- 6- to 12-years-old

- classified as DCD according to the Diagnostic and Statistical Manual of Mental Disorders V

- score < 5th percentile on the Movement Assessment Battery for Children, 2nd edition (MABC-2)

- total score < 46 on the DCD questionnaire (2007)

- attending a mainstream primary school with intelligence level within the normal range

- no KT or FMPT experience

Exclusion Criteria:

- any known congenital, cognitive, psychiatric, neurological, sensorimotor, musculoskeletal or cardiopulmonary disorder that may affect test performance

- receiving active rehabilitation treatment

- demonstrating excessive disruptive behaviour

- unable to follow instructions

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Kinesio Taping - Functional Movement Power Training
Subjects assigned to the Kinesio Taping - Functional Movement Power Training (KT-FMPT) group will receive FMPT concurrent with KT. The FMPT protocol was developed by the research team with reference to common physiotherapeutic exercises for children with motor disabilities.9 It comprises 5 functional movement exercises and 6 lower-limb power/resistance training exercises using weights or resistance bands.
Jogging with placebo taping
Subjects assigned to the control group will receive no FMPT or KT, but participate in a jogging intervention with placebo tape applied on their calf muscles and removed after the intervention.

Locations

Country Name City State
Hong Kong University of Hong Kong Hong Kong

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 leg muscle electromyographic activation onset latency time (in ms) Electromyographic activation onset of leg muscles 0 and 3 months
Primary Change in centre of pressure movement pathway in standing (in mm/cm) Centre of pressure movement pathway in standing 0 and 3 months
Secondary Change in lower-extremity maximum isometric muscle strength (in kg/N) Maximum isometric leg muscle strength 0 and 3 months
Secondary Change in Movement Assessment Battery for Children-2 percentile score Movement Assessment Battery for Children-2 percentile (motor proficiency) 0 and 3 months
Secondary Change in Pediatric Evaluation of Disability Inventory score Pediatric Evaluation of Disability Inventory score (functional independence) 0 and 3 months
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