TapingNCT03815526
The Immediate Effects of Applying Dynamic Tape, Kinesio Tape and Sport Tape With Chronic Ankle Instability
A study testing Dynamic tape, Kinesio tape and Sport tape in people with Taping and Ankle Sprains, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Taping, Ankle Sprains
- What is being tested?
- Dynamic tape, Kinesio tape and Sport tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 May 2019to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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'.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Wanfang Hospital
Taipei, 116
Chien-Yung Wang, 0229307930 ext. 1624, 106021@w.tmu.edu.tw
About this study
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.
Read more
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.
- Conditions
- Taping, Ankle Sprains
- Being tested
- Dynamic tape, Kinesio tape, Sport tape
- Keywords
- DynamicTape, Sport Tape, Kinesio Tape
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic tapeOther
Dynamic tape apply 1 time
Kinesio tapeOther
Dynamic tape apply 1 time
Sport tapeOther
Dynamic tape apply 1 time
| Study group | Role | What they receive |
|---|---|---|
| Dynamic tape | Experimental | Not described Receives: Other: Dynamic tape |
| Kinesio tape | Experimental | Not described Receives: Other: Kinesio tape |
| Sport tape | Experimental | Not described Receives: Other: Sport tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex Balance System
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)
Measured: 1 day
Secondary outcomes (2)
Y-balance test
dynamic reach (cm): anterior, posterior/medial, posterior/lateral
Measured: 1 day
Single leg hop test
single leg hop laterally distance (cm) and 15 cm side hop time(second)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start10 May 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TapingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815526
- Sponsor's protocol ID
- N201811015
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effects of Applying Dynamic Tape, Kinesio Tape and Sport Tape With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT03815526
- Acronym / sponsor ID
- N201811015
- Conditions
- Taping, Ankle Sprains
- Keywords
- DynamicTape, Sport Tape, Kinesio Tape
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dynamic tape | Experimental | Other: Dynamic tape |
| Kinesio tape | Experimental | Other: Kinesio tape |
| Sport tape | Experimental | Other: Sport tape |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A history of at least one significant ankle sprain
- A history of the previously injured ankle joint 'giving way' , and /or recurrent sprain and/or 'feelings of instability'.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic tapeDynamic tape apply 1 time | Other | Dynamic tape |
| Kinesio tapeDynamic tape apply 1 time | Other | Kinesio tape |
| Sport tapeDynamic tape apply 1 time | Other | Sport tape |
Primary outcome
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)
2 secondary outcomes
Y-balance test
Time frame: 1 day
Single leg hop test
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic tape, Kinesio tape and Sport tape in people with Taping and Ankle Sprains, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chien-Yung CY Wang, MS (+886-229307930 ext. 1624, 106021@w.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex Balance System (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.