- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03815526
The Immediate Effects of Applying Dynamic Tape, Kinesio Tape and Sport Tape With Chronic Ankle Instability
Injuries to the ankle joint account for 20% of the population that is afflicted with joint injury and the largest percentage of self-reported musculoskeletal injuries (> 10%) are to the ankle. Ankle sprain has a large portion in ankle injuries and occurs not only in the sporting population but also in the general community. Although the acute symptom would be resolve quickly, but many people still report persisting problems, such as pain and instability. Chronic ankle instability (CAI) is one of the most common of these residual problems.
Kinesio Tape and White Duck Tape are often applied in patients with CAI, attempt to increase the ankle joint stability, and improve motor performance. However, the previous studies had controversial result to the effects of kinesio tape and white duck tape. The previous studies also showed the insufficient of supporting force and elasticity of kinesio tape and white duct tape. The Dynamic Tape was developed by Kendrick in 2009, which refined the characteristic of elasticity and supporting force.
Therefore the purpose of study is to comparison the effects of static and dynamic balance performance, weight shifting ability and functional movement between kinesio tape, white duck tape and dynamic tape when applied on patients with CAI. With the result may provide an optical method to increase the movement performance of patients with CAI.
The study suspected to recruit 90 volunteers with CAI, and randomly divided to three different groups: Kinesio tape group, White duck tape group and Dynamic tape group. We make postural stability test and limit postural stability test with Biodex Balance System (SD), Y-balance test and single leg hop test to both affected side and sound side foot before applying the tape. After applying the tape according to the divided group, we will repeat the test above again. We will compare the results of the test between groups and within groups.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chien-Yung CY Wang, MS
- Phone Number: 1624 +886-229307930
- Email: 106021@w.tmu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 116
- Recruiting
- WanFang Hospital
-
Contact:
- Chien-Yung Wang
- Phone Number: 1624 0229307930
- Email: 106021@w.tmu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
A history of at least one significant ankle sprain
- The initial sprain must have occurred at least 12 months prior to the study enrolment
- Was associated with inflammatory symptoms (pain, swelling, etc)
- Created at least one interrupted day of desired physical activity
- A history of the previously injured ankle joint 'giving way' , and /or recurrent sprain and/or 'feelings of instability'.
Exclusion Criteria:
- A history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures and nerves) in either lower extremity.
- A history of a fracture in either lower extremity requiring realignment.
- Acute injury to the musculoskeletal structures of other joints of the lower extremity in the previous 1 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least 1 interrupted day of desired physical activity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dynamic tape
|
Dynamic tape apply 1 time
|
Experimental: Kinesio tape
|
Dynamic tape apply 1 time
|
Experimental: Sport tape
|
Dynamic tape apply 1 time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biodex Balance System
Time Frame: 1 day
|
Overall Stability Index, Anterior/Posterior Index, Medial/Lateral Index Limits of stability direction control score (Overall, Forward, Backward, Right, Left, Forward/Right, Forward/Left, Backward/Right, Backward/Left)
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Y-balance test
Time Frame: 1 day
|
dynamic reach (cm): anterior, posterior/medial, posterior/lateral
|
1 day
|
Single leg hop test
Time Frame: 1 day
|
single leg hop laterally distance (cm) and 15 cm side hop time(second)
|
1 day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N201811015
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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