Efficacy of an Innovative Kinesiotaping Bandage Compared to Traditional Tape in Stabilising Ankle Inversion and Plantar Flexion in Triathletes.

NCT ID: NCT06701994

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-27

Study Completion Date

2025-01-30

Brief Summary

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Efficacy of an Innovative Kinesiotaping Bandage Compared to Traditional Tape in Stabilising Ankle Inversion and Plantar Flexion in Triathletes: A Triple-Blind Experimental Study.

Background and Purpose:

Lateral ankle sprains are a common injury among triathletes, impacting their performance and recovery time. Although traditional functional tape is effective in stabilising the ankle joint, it has limitations in aquatic sports due to its lack of water resistance. This study will evaluate the efficacy of an innovative kinesiotaping (KT) bandage, designed to combine water resistance with the restrictive properties of traditional tape. The primary objective will be to determine which type of bandage is more effective in stabilising ankle inversion and plantar flexion in triathletes.

Study Design:

This will be a triple-blind experimental study involving 20 federated triathletes. Each participant will have three different bandages (traditional tape, innovative KT, and placebo) applied in a randomised order. Goniometric and functional tests will be used to measure the outcomes.

Interventions:

Traditional Tape: Standard restrictive bandage. Innovative KT Bandage: Elastic, water-resistant bandage with additional restrictive properties.

Placebo: Gauze bandage without stabilising properties.

Methods of Evaluation:

Goniometric measurements (flexion, inversion) and functional tests (Star Excursion Balance Test, Hopping Test, Vertical Jump Test) will be conducted. The bandages will be applied and evaluated in a controlled environment, with participants and investigators blinded to the type of bandage.

Expected Outcomes:

It is anticipated that the innovative KT bandage will provide stabilisation comparable to traditional tape for critical ankle movements while overcoming the limitations of tape in aquatic conditions. It is also expected to demonstrate significant advantages in functional tests.

Clinical Relevance:

This study aims to provide evidence for optimising the management of ankle injuries in triathletes, offering a practical and effective solution to maintain athletic performance under demanding conditions.

Detailed Description

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Conditions

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Athletes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Kinesiotaping Bandage Group

A bandage using kinesiotape will be applied to the participant's ankle directly on the skin and covered with an opaque stocking.

Group Type EXPERIMENTAL

Innovative Kinesiotaping Bandage Group

Intervention Type BEHAVIORAL

This group will receive an innovative kinesiotaping bandage developed specifically for this study. The kinesiotape will be applied directly to the skin on the ankle, combining water resistance with restrictive properties to stabilise the joint while maintaining flexibility. Unlike traditional tape, the kinesiotape is designed to perform well in aquatic conditions, making it suitable for triathlon demands. It provides joint support while allowing a greater range of motion, aiming to enhance performance across all phases of the sport. To maintain blinding, the bandage will also be covered with an opaque stocking.

Traditional Tape Bandage Group

A bandage will be applied to the participant's ankle using kinesiotape directly on the skin and covered with an opaque stocking.

Group Type ACTIVE_COMPARATOR

Traditional Tape Bandage Group

Intervention Type BEHAVIORAL

Participants in this group will receive a traditional ankle bandage using functional tape. The bandage is applied directly to the skin and is designed to restrict ankle inversion and plantar flexion, providing stability to prevent recurrent injuries. Traditional tape bandages are widely used in sports due to their effective joint stabilisation. However, they have significant limitations in aquatic environments as they lack water resistance, which makes them less effective during the swimming phase of triathlons. The bandage will be covered with an opaque stocking to ensure blinding, preventing participants or evaluators from identifying the type of intervention.

Placebo Group

An opaque stocking is placed on the participant's ankle.

Group Type PLACEBO_COMPARATOR

Placebo Bandage Group

Intervention Type BEHAVIORAL

Participants in this group will receive a placebo bandage consisting of a simple gauze wrap applied directly to the ankle. The gauze lacks stabilising or therapeutic properties and is used as a control to account for potential placebo effects. Although it mimics the application process of the other bandages, it does not provide functional or structural support to the ankle joint. An opaque stocking will cover the gauze to ensure that neither participants nor evaluators can distinguish the placebo bandage from the others, maintaining the integrity of the blinding process.

Interventions

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Innovative Kinesiotaping Bandage Group

This group will receive an innovative kinesiotaping bandage developed specifically for this study. The kinesiotape will be applied directly to the skin on the ankle, combining water resistance with restrictive properties to stabilise the joint while maintaining flexibility. Unlike traditional tape, the kinesiotape is designed to perform well in aquatic conditions, making it suitable for triathlon demands. It provides joint support while allowing a greater range of motion, aiming to enhance performance across all phases of the sport. To maintain blinding, the bandage will also be covered with an opaque stocking.

Intervention Type BEHAVIORAL

Traditional Tape Bandage Group

Participants in this group will receive a traditional ankle bandage using functional tape. The bandage is applied directly to the skin and is designed to restrict ankle inversion and plantar flexion, providing stability to prevent recurrent injuries. Traditional tape bandages are widely used in sports due to their effective joint stabilisation. However, they have significant limitations in aquatic environments as they lack water resistance, which makes them less effective during the swimming phase of triathlons. The bandage will be covered with an opaque stocking to ensure blinding, preventing participants or evaluators from identifying the type of intervention.

Intervention Type BEHAVIORAL

Placebo Bandage Group

Participants in this group will receive a placebo bandage consisting of a simple gauze wrap applied directly to the ankle. The gauze lacks stabilising or therapeutic properties and is used as a control to account for potential placebo effects. Although it mimics the application process of the other bandages, it does not provide functional or structural support to the ankle joint. An opaque stocking will cover the gauze to ensure that neither participants nor evaluators can distinguish the placebo bandage from the others, maintaining the integrity of the blinding process.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adult men (over 18 years old).
* Federated triathletes.
* No medical conditions or pathologies that could affect the measurements.
* Signed informed consent.

Exclusion Criteria

* Recent surgeries that compromise ankle function.
* Severe prior ankle injuries (fractures, ligament tears).
* Presence of chronic musculoskeletal diseases.
* Use of ankle support devices during the tests.
* History of severe dermatological allergies or intolerance to the materials used in the bandages.
* Use of supplements or medications that could influence muscular or joint performance.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Vigo

OTHER

Sponsor Role lead

Responsible Party

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Pablo Hernandez-Lucas

Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pontevedra

Pontevedra, , Spain

Site Status

Countries

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Spain

Other Identifiers

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Vendaje Ogando

Identifier Type: -

Identifier Source: org_study_id

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