Ankle SprainsNCT04568577
Effects of the Elastic Taping on the Chronic Ankle Instability
A study testing Tape with tension and Tape without tension in people with Ankle Sprains and Chronic Ankle Instability, run by Universidade Norte do Paraná at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Ankle Sprains, Chronic Ankle Instability, Athletes Foot
- What is being tested?
- Tape with tension and Tape without tension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2019to 26 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ankle Sprains, Chronic Ankle Instability, Athletes Foot
- Being tested
- Tape with tension, Tape without tension
- Keywords
- Athletic Tape, Ankle Sprains, Chronic Ankle Instability
- Medical subject headings
- Ankle Injuries, Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tape with tensionOther
Also called Elastic tape, Kinesiotaping, Tape tensioned, Elastic bandage
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 tensionOther
Also called elastic tape, elastic bandage, kinesiotaping
Bandaging applications will be weekly, for five weeks, without tensioning the tape.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Tape without tension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)
Secondary outcomes (2)
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.
Measured: The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)
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.
Measured: The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Apr 2019
- Primary completion24 Jun 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Norte do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gustavo FM Oliveira, researcher, Principal investigator, Universidade Norte do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568577
- Sponsor's protocol ID
- 3.059.113
- Status last verified
- Sep 2020
- First submitted
- 14 May 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29171312Delahunt 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.
PubMed 31161942
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Elastic Taping on the Chronic Ankle Instability: a Clinical Trial
- ClinicalTrials.gov ID
- NCT04568577
- Acronym / sponsor ID
- 3.059.113
- Conditions
- Ankle Sprains, Chronic Ankle Instability, Athletes Foot
- Keywords
- Athletic Tape, Ankle Sprains, Chronic Ankle Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Universidade Norte do ParanáUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tensioned tape | Experimental | Other: Tape with tensionThe 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. |
| tape without tension | Active comparator | Other: Tape without tensionThe tensionless tape group will receive the application of the tape weekly without tensioning during the five weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tape with tensionAlso: Elastic tape, Kinesiotaping, Tape tensioned, Elastic bandageThe 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 | tensioned tape |
| Tape without tensionAlso: elastic tape, elastic bandage, kinesiotapingBandaging applications will be weekly, for five weeks, without tensioning the tape. | Other | tape without tension |
Primary outcome
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.
2 secondary outcomes
Balance
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Background: PubMed 29171312Miklovic 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 publication: PubMed 31161942Delahunt 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.
- Individual participant dataSharing planned: No
Related trials for Ankle Sprains
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustavo FM Oliveira, researcher principal investigator
Universidade Norte do Paraná
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tape with tension and Tape without tension in people with Ankle Sprains and Chronic Ankle Instability, run by Universidade Norte do Paraná at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functionality (time frame: The evaluation will occur at week 1 (baseline) and at the end of the protocol (week 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04568577, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.