Effects of the Elastic Taping on the Chronic Ankle Instability

September 23, 2020 updated by: Universidade Norte do Paraná

Effects of the Elastic Taping on the Chronic Ankle Instability: a Clinical Trial

This study will analyze the effects of an elastic taping application protocol in individuals with chronic ankle instability. One group will perform a protocol with increased tape tension for five weeks while the other group will receive the same tape without tension during the same period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Elastic taping is a method widely used in clinical practice for the treatment of ankle instability and shows increasing interest in research to verify its effectiveness. The literature presents several studies with short-term effects, largely in healthy individuals and with several application techniques, with the incremental tensioning of the proposed tape subjectively.

The literature presents several studies with short-term effects, largely in healthy individuals and with several application techniques, with the incremental tensioning of the proposed tape subjectively.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Parana
      • Londrina, Parana, Brazil, 86041-120
        • Gustavo Felipe Marques de Oliveira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • young adults with chronic ankle instability (unilateral or bilateral);
  • the first sprain episode occurred for at least 1 year pre-study associated with inflammatory symptoms (pain, edema, etc.);
  • having discontinued for at least 1 day physical activity;
  • the most recent sprain occurred more than 3 months prior study;
  • self-reported instability feeling to be confirmed by specific questionnaires.

Exclusion Criteria:

  • lower limb surgical procedure;
  • lower limb fracture history;
  • acute injury (last 3 months) of other lower limb joints resulting in at least 1 day in the interruption of physical activity;
  • wounds in the ankle region or foot;
  • own skin disease;
  • have allergy to bandage;
  • be in physiotherapeutic treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tensioned tape
The tensioned tape group will apply weekly with gradual tension calculated by measuring the initial length of the tape. From the first week of application, there will be a 5% increase in tension up to the fifth week.
Other: Tape with tension
The elastic bandage will be applied with a voltage increase controlled weekly, for five weeks. Each week, 5% of tension will be added to the application. In the first week the application will be tension-free.
Other Names:
  • Kinesiotaping
  • Elastic bandage
  • Elastic tape
  • Tape tensioned
Active Comparator: tape without tension
The tensionless tape group will receive the application of the tape weekly without tensioning during the five weeks.
Other: Tape without tension
Bandaging applications will be weekly, for five weeks, without tensioning the tape.
Other Names:
  • kinesiotaping
  • elastic tape
  • elastic bandage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functionality
Time Frame: The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)
The functionality will be evaluated by the average of three executions of the side hop test and dynamic balance test (star excursion balance test modified). The side hop test consists of lateral jumps beyond the 30 cm mark on the ground in the shortest possible time (the shorter the time, the better the performance). The dynamic balance test consists of remaining in unipodal support and reaching as far as possible with the other member in the anterior, posteromedial and posterolateral directions. The greater the distance achieved improves the score. The calculation is performed to correct the measurements.
The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)
The balance will be evaluated by the force platform at baseline. The variables center of pressure, speed of displacement of the center of pressure in the anteroposterior and mediolateral directions, frequency of displacement of the center of pressure in the anteroposterior and mediolateral directions will be analyzed. The lower the score, the better the performance.
The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)
Self-reported instability
Time Frame: The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)
Self-reported instability will be assessed by questionnaire. The Cumberland Ankle Instability Tool consists of 9 questions with a maximum score of 30 points. Ankle instability is considered to have a score less than or equal to 24. The lower the score, the worse the instability. The other questionnaire used will be Foot and Ankle Outcome Score, which has 42 questions divided into 5 domains. Each domain has a score of 100%. If the individual has <75% in 3 domains, he is considered to have functional ankle instability. The lower the score, the worse the instability.
The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Norte do Paraná

Investigators

  • Principal Investigator: Gustavo FM Oliveira, researcher, Universidade Norte do Paraná

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

June 24, 2019

Study Completion (Actual)

August 26, 2019

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 23, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3.059.113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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