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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04568577
Other study ID # 3.059.113
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date August 26, 2019

Study information

Verified date September 2020
Source Universidade Norte do Paraná
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date August 26, 2019
Est. primary completion date June 24, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

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.
Tape without tension
Bandaging applications will be weekly, for five weeks, without tensioning the tape.

Locations

Country Name City State
Brazil Gustavo Felipe Marques de Oliveira Londrina Parana

Sponsors (1)

Lead Sponsor Collaborator
Universidade Norte do Paraná

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. Review. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)
Secondary 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. The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)
Secondary 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. The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)
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