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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01792908
Other study ID # T11230S
Secondary ID R02/2010
Status Completed
Phase N/A
First received February 12, 2013
Last updated February 14, 2013
Start date October 2011
Est. completion date April 2012

Study information

Verified date February 2013
Source University Rovira i Virgili
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Kinesio 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

Locations

Country Name City State
Spain Faculty of Medicina i Ciències de la Salut; University Rovira i Virgili. Reus Tarragona

Sponsors (1)

Lead Sponsor Collaborator
University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Miralles I, Monterde S, Montull S, Salvat I, Fernández-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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Change from baseline in proprioception at 48h Yes
Secondary 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. Change from baseline in proprioception at 48h Yes
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