- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04123912
Kinesio Taping and Physiotherapeutic Exercises for Children With DCD
Effect of Kinesio Taping and Functional Movement Power Training on Neuromuscular Performance, Motor Proficiency and Functional Independence in Children With Developmental Coordination Disorder: A Randomised Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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PLACEBO_COMPARATOR: Control group
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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.
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EXPERIMENTAL: KT-FMPT group
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in leg muscle electromyographic activation onset latency time (in ms)
Time Frame: 0 and 3 months
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Electromyographic activation onset of leg muscles
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0 and 3 months
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Change in centre of pressure movement pathway in standing (in mm/cm)
Time Frame: 0 and 3 months
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Centre of pressure movement pathway in standing
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0 and 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in lower-extremity maximum isometric muscle strength (in kg/N)
Time Frame: 0 and 3 months
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Maximum isometric leg muscle strength
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0 and 3 months
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Change in Movement Assessment Battery for Children-2 percentile score
Time Frame: 0 and 3 months
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Movement Assessment Battery for Children-2 percentile (motor proficiency)
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0 and 3 months
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Change in Pediatric Evaluation of Disability Inventory score
Time Frame: 0 and 3 months
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Pediatric Evaluation of Disability Inventory score (functional independence)
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0 and 3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0001 (Researcher)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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