Sprains and StrainsNCT01792908
Kinesio Tape Effects on Ankle Proprioception
A study testing Kinesio tape in people with Sprains and Strains, run by University Rovira i Virgili at 1 site in Spain.
Trial summary
The aim of the present study was to establish whether Kinesio Tape (KT) on the ankle (Kase protocol for the lateral ankle ligament) improves Joint Position Sense (JPS) in healthy volunteers immediately after its application and 48 hours later. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sprains and Strains
- What is being tested?
- Kinesio tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2011to Apr 2012
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be signed the informed consent
- Aged between 18 and 35 years
- Did not suffered from ankle or foot skin diseases
- Active dorsal/plantarflexion ARoM equal to or above 15º and inversion/eversion
- ARoM equal to or above 5º.
Who cannot join
- Traumatic, neurological or circulatory diseases diagnosed
- Joint laxity
- More than three ankle sprains in their lives or one in the last 12 months that required treatment and ankle or foot pain at the time of study enrolment in the non-dominant lower limb.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Medicina i Ciències de la Salut; University Rovira i Virgili.
Reus, Tarragona, 43201
About this study
Official title: Has Kinesio Tape Effects on Ankle Proprioception? A Randomized Clinical Trial
The aim of the present study was to establish whether Kinesio Tape (KT) on the ankle (Kase protocol for the lateral ankle ligament) improves Joint Position Sense (JPS) in healthy volunteers immediately after its application and 48 hours later.
Read the detailed description
The investigators assessed Joint Position Sense (JPS) through the difference of error (DoE) and the deviation of the target angle (DTA). JPS was assessed before the Kinesio Tape (KT) was placed, immediately after and 48 hours later.
- Conditions
- Sprains and Strains
- Being tested
- Kinesio tape
- Keywords
- ankle lateral ligament, athletic tape, position sense, Proprioception
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapeDevice
Also called Kinesio-tape; Kinesiotape; KinesioTM tape
The KT used was Kinesiology Tape® of 5 cm and it was applied according to Kase protocol (Kase K). The first layer of tape consisted of a single strip placed over the anterior talofibular ligament from insertion to origin, with a 50% tension, except the two-centimetre proximal and distal ends, applied with no tension. The same procedure was repeated for the calcaneofibular ligament and posterior talofibular ligament
| Study group | Role | What they receive |
|---|---|---|
| KT group | Experimental | The KT group received ankle KT on the lateral ligament in the non-dominant leg and a recommendation guide. The Kinesio tape procedure was carried out by the same certified athletic therapist to ensure consistency throughout the study. Receives: Device: Kinesio tape |
| Control group | No intervention | Any intervention has been applied. Using another kind of tape or a different KT application for control group may increase cutaneous information, undermining our goal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint position sense on the Difference of Error from the target angle
The primary outcome, difference of error (DE) in degrees was calculated to show changes in error from the target angle over time. We compared error, before and immediately after intervention (DoE 1-2), before and 48 hours after intervention (DE 1-3) and immediately and 48 hours after intervention (DE 2-3).
Measured: Change from baseline in proprioception at 48h
Secondary outcomes (1)
Deviation of the target angle
We also calculated the deviation from the target angle (DTA) in degrees, this secondary outcome to describe the direction of error when subjects tried to reproduce the requested position. Deviation was obtained encoding net error taking as correct position when the target and the estimated angle were equal, considering the precision of the electronic plate a valid range (0.4 degrees). Values above this range were classified as Overestimation and as Underestimation when values were below this range.
Measured: Change from baseline in proprioception at 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startOct 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sprains and StrainsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iris Miralles Rull, University Rovira i Virgili
- Investigators
- Iris Miralles, Principal investigator, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792908
- Sponsor's protocol ID
- T11230S
- Other IDs
- R02/2010
- Status last verified
- Feb 2013
- First submitted
- 12 Feb 2013
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miralles I, Monterde S, Montull S, Salvat I, Fernandez-Ballart J, Beceiro J. Ankle taping can improve proprioception in healthy volunteers. Foot Ankle Int. 2010 Dec;31(12):1099-106. doi: 10.3113/FAI.2010.1099.
PubMed 21189212
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Has Kinesio Tape Effects on Ankle Proprioception? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01792908
- Acronym / sponsor ID
- T11230S
- Conditions
- Sprains and Strains
- Keywords
- ankle lateral ligament, athletic tape, position sense, Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 15 Feb 2013 (estimated)
- 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.
The aim of the present study was to establish whether Kinesio Tape (KT) on the ankle (Kase protocol for the lateral ankle ligament) improves Joint Position Sense (JPS) in healthy volunteers immediately after its application and 48 hours later.
Detailed description
The investigators assessed Joint Position Sense (JPS) through the difference of error (DoE) and the deviation of the target angle (DTA). JPS was assessed before the Kinesio Tape (KT) was placed, immediately after and 48 hours later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KT group | Experimental | Device: Kinesio tapeThe KT group received ankle KT on the lateral ligament in the non-dominant leg and a recommendation guide. The Kinesio tape procedure was carried out by the same certified athletic therapist to ensure consistency throughout the study. |
| Control group | No intervention | –Any intervention has been applied. Using another kind of tape or a different KT application for control group may increase cutaneous information, undermining our goal. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must be signed the informed consent
- Aged between 18 and 35 years
- Did not suffered from ankle or foot skin diseases
- Active dorsal/plantarflexion ARoM equal to or above 15º and inversion/eversion
- ARoM equal to or above 5º.
Key exclusion criteria (3 listed)
- Traumatic, neurological or circulatory diseases diagnosed
- Joint laxity
- More than three ankle sprains in their lives or one in the last 12 months that required treatment and ankle or foot pain at the time of study enrolment in the non-dominant lower limb.
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 |
|---|---|---|
| Kinesio tapeAlso: Kinesio-tape; Kinesiotape; KinesioTM tapeThe KT used was Kinesiology Tape® of 5 cm and it was applied according to Kase protocol (Kase K). The first layer of tape consisted of a single strip placed over the anterior talofibular ligament from insertion to origin, with a 50% tension, except the two-centimetre proximal and distal ends, applied with no tension. The same procedure was repeated for the calcaneofibular ligament and posterior talofibular ligament | Device | KT group |
Primary outcome
Joint position sense on the Difference of Error from the target angle
Time frame: Change from baseline in proprioception at 48h
The primary outcome, difference of error (DE) in degrees was calculated to show changes in error from the target angle over time. We compared error, before and immediately after intervention (DoE 1-2), before and 48 hours after intervention (DE 1-3) and immediately and 48 hours after intervention (DE 2-3).
1 secondary outcome
Deviation of the target angle
Time frame: Change from baseline in proprioception at 48h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- Background: PubMed 21189212Miralles I, Monterde S, Montull S, Salvat I, Fernandez-Ballart J, Beceiro J. Ankle taping can improve proprioception in healthy volunteers. Foot Ankle Int. 2010 Dec;31(12):1099-106. doi: 10.3113/FAI.2010.1099.
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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.
Iris Miralles principal investigator
University Rovira i Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio tape in people with Sprains and Strains, run by University Rovira i Virgili at 1 site in Spain.
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: finished, as of the sponsor's last update on 15 Feb 2013. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint position sense on the Difference of Error from the target angle (time frame: Change from baseline in proprioception at 48h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01792908, which also lists 1 linked publication.
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 15 Feb 2013; AzTrials last refreshed its copy on 27 Oct 2026.