- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02945124
Taping for Children With and Without Movement Clumsiness
October 24, 2016 updated by: Shirley S.M. Fong, The University of Hong Kong
The Effects of K-Tape on Walking Pattern, Muscle Activity, and Motor Performance in Children With and Without Developmental Coordination Disorder: a Randomized Controlled Trial
To investigate the effects of K Tape on walking pattern, muscle activity and motor performance in children with and without developmental coordination disorder (DCD).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pokfulam, Hong Kong
- University of Hong Kong
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 9 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children with DCD and typically developing children will need to score <16 percentile and >25 percentile, respectively, on MABC-2
- Study in mainstream schools
- No intellectual disabilities
Exclusion Criteria:
- Subjects who are receiving regular treatments
- Demonstrate excessive disruptive behaviour
- Unable to follow instructions
- Any diagnosis of neurological, musculoskeletal or cognitive disorder that affects test performance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Normal children with K Tape
|
Applying K tape to children to the lower limb muscles during motor activities.
|
|
No Intervention: Normal children without K Tape
|
|
|
Experimental: DCD with K Tape
|
Applying K tape to children to the lower limb muscles during motor activities.
|
|
No Intervention: DCD without K Tape
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in lower limb muscle activation as measured by electromyography
Time Frame: Day 1 and day 2 (ms)
|
Post K Tape lower limb muscle activity - pre K Tape lower limb muscle activation
|
Day 1 and day 2 (ms)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in balance performance as measured by force plate
Time Frame: Day 1 and day 2
|
Post K Tape balance performance - pre K Tape balance performance
|
Day 1 and day 2
|
|
Foot posture as assessed by clinical observation
Time Frame: Day 1 and Day 2
|
Day 1 and Day 2
|
|
|
Body composition as assessed by DXA
Time Frame: Day 1 and Day 2
|
Day 1 and Day 2
|
|
|
Change in walking pattern as assessed by a motion analysis system
Time Frame: Day 1 and day 2
|
Post K Tape walking pattern - pre K Tape walking pattern
|
Day 1 and day 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
September 10, 2016
First Submitted That Met QC Criteria
October 24, 2016
First Posted (Estimate)
October 26, 2016
Study Record Updates
Last Update Posted (Estimate)
October 26, 2016
Last Update Submitted That Met QC Criteria
October 24, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EA1512037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.