NCT04568577

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

May 14, 2020

Last Update Submit

September 23, 2020

Conditions

Keywords

Athletic TapeAnkle SprainsChronic Ankle Instability

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Balance

    The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)

  • Self-reported instability

    The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)

Study Arms (2)

tensioned tape

EXPERIMENTAL

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

tape without tension

ACTIVE COMPARATOR

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

Other: Tape without tension

Interventions

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.

Also known as: Elastic tape, Kinesiotaping, Tape tensioned, Elastic bandage
tensioned tape

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

Also known as: elastic tape, elastic bandage, kinesiotaping
tape without tension

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustavo Felipe Marques de Oliveira

Londrina, Paraná, 86041-120, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 29171312BACKGROUND
  • 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.

MeSH Terms

Conditions

Ankle InjuriesTinea Pedis

Interventions

Compression Bandages

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesTineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousFoot DermatosesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPruritusSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BandagesEquipment and Supplies

Study Officials

  • Gustavo FM Oliveira, researcher

    Universidade Norte do Paraná

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2020

First Posted

September 29, 2020

Study Start

April 1, 2019

Primary Completion

June 24, 2019

Study Completion

August 26, 2019

Last Updated

September 29, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations