NCT01792908

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

6 months

First QC Date

February 12, 2013

Last Update Submit

February 14, 2013

Conditions

Sprains and Strains

Keywords

ankle lateral ligamentathletic tapeposition senseProprioception

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Deviation of the target angle

    Change from baseline in proprioception at 48h

Study Arms (2)

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.

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.

Interventions

Kinesio tapeDEVICE

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

Also known as: Kinesio-tape; Kinesiotape; KinesioTM tape
KT group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicina i Ciències de la Salut; University Rovira i Virgili.

Reus, Tarragona, 43201, Spain

Location

Related Publications (1)

  • 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.

    PMID: 21189212BACKGROUND

MeSH Terms

Conditions

Sprains and Strains

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Iris Miralles

    University Rovira i Virgili

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 12, 2013

First Posted

February 15, 2013

Study Start

October 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

ES(1)