search
Back to results

Effects of the Elastic Taping on the Chronic Ankle Instability

Primary Purpose

Ankle Sprains, Chronic Ankle Instability, Athletes Foot

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Tape with tension
Tape without tension
Sponsored by
Universidade Norte do Paraná
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprains focused on measuring Athletic Tape, Ankle Sprains, Chronic Ankle Instability

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gustavo Felipe Marques de Oliveira

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tensioned tape

tape without tension

Arm Description

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.

The tensionless tape group will receive the application of the tape weekly without tensioning during the five weeks.

Outcomes

Primary Outcome Measures

Functionality
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.

Secondary Outcome Measures

Balance
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.
Self-reported instability
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.

Full Information

First Posted
May 14, 2020
Last Updated
September 23, 2020
Sponsor
Universidade Norte do Paraná
search

1. Study Identification

Unique Protocol Identification Number
NCT04568577
Brief Title
Effects of the Elastic Taping on the Chronic Ankle Instability
Official Title
Effects of the Elastic Taping on the Chronic Ankle Instability: a Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
June 24, 2019 (Actual)
Study Completion Date
August 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Norte do Paraná

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains, Chronic Ankle Instability, Athletes Foot
Keywords
Athletic Tape, Ankle Sprains, Chronic Ankle Instability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tensioned tape
Arm Type
Experimental
Arm Description
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.
Arm Title
tape without tension
Arm Type
Active Comparator
Arm Description
The tensionless tape group will receive the application of the tape weekly without tensioning during the five weeks.
Intervention Type
Other
Intervention Name(s)
Tape with tension
Other Intervention Name(s)
Elastic tape, Kinesiotaping, Tape tensioned, Elastic bandage
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tape without tension
Other Intervention Name(s)
elastic tape, elastic bandage, kinesiotaping
Intervention Description
Bandaging applications will be weekly, for five weeks, without tensioning the tape.
Primary Outcome Measure Information:
Title
Functionality
Description
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.
Time Frame
The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)
Secondary Outcome Measure Information:
Title
Balance
Description
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.
Time Frame
The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)
Title
Self-reported instability
Description
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.
Time Frame
The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo FM Oliveira, researcher
Organizational Affiliation
Universidade Norte do Paraná
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gustavo Felipe Marques de Oliveira
City
Londrina
State/Province
Parana
ZIP/Postal Code
86041-120
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29171312
Citation
Miklovic TM, Donovan L, Protzuk OA, Kang MS, Feger MA. Acute lateral ankle sprain to chronic ankle instability: a pathway of dysfunction. Phys Sportsmed. 2018 Feb;46(1):116-122. doi: 10.1080/00913847.2018.1409604. Epub 2017 Nov 29.
Results Reference
background
PubMed Identifier
31161942
Citation
Delahunt E, Remus A. Risk Factors for Lateral Ankle Sprains and Chronic Ankle Instability. J Athl Train. 2019 Jun;54(6):611-616. doi: 10.4085/1062-6050-44-18. Epub 2019 Jun 4.
Results Reference
result

Learn more about this trial

Effects of the Elastic Taping on the Chronic Ankle Instability

We'll reach out to this number within 24 hrs