Kinesio Taping and Physiotherapeutic Exercises for Children With DCD
Primary Purpose
Developmental Coordination Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Kinesio Taping - Functional Movement Power Training
Jogging with placebo taping
Sponsored by
About this trial
This is an interventional treatment trial for Developmental Coordination Disorder
Eligibility Criteria
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
Sites / Locations
- University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KT-FMPT group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Change in leg muscle electromyographic activation onset latency time (in ms)
Electromyographic activation onset of leg muscles
Change in centre of pressure movement pathway in standing (in mm/cm)
Centre of pressure movement pathway in standing
Secondary Outcome Measures
Change in lower-extremity maximum isometric muscle strength (in kg/N)
Maximum isometric leg muscle strength
Change in Movement Assessment Battery for Children-2 percentile score
Movement Assessment Battery for Children-2 percentile (motor proficiency)
Change in Pediatric Evaluation of Disability Inventory score
Pediatric Evaluation of Disability Inventory score (functional independence)
Full Information
NCT ID
NCT04123912
First Posted
October 8, 2019
Last Updated
October 10, 2019
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04123912
Brief Title
Kinesio Taping and Physiotherapeutic Exercises for Children With DCD
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Coordination Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KT-FMPT group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Kinesio Taping - Functional Movement Power Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Jogging with placebo taping
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in leg muscle electromyographic activation onset latency time (in ms)
Description
Electromyographic activation onset of leg muscles
Time Frame
0 and 3 months
Title
Change in centre of pressure movement pathway in standing (in mm/cm)
Description
Centre of pressure movement pathway in standing
Time Frame
0 and 3 months
Secondary Outcome Measure Information:
Title
Change in lower-extremity maximum isometric muscle strength (in kg/N)
Description
Maximum isometric leg muscle strength
Time Frame
0 and 3 months
Title
Change in Movement Assessment Battery for Children-2 percentile score
Description
Movement Assessment Battery for Children-2 percentile (motor proficiency)
Time Frame
0 and 3 months
Title
Change in Pediatric Evaluation of Disability Inventory score
Description
Pediatric Evaluation of Disability Inventory score (functional independence)
Time Frame
0 and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Kinesio Taping and Physiotherapeutic Exercises for Children With DCD
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