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

NCT06701994 | Completed

• 1 other identifier: Vendaje Ogando
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Athletes

Outcome Measures

Primary Outcomes (1)

• Ankle Goniometry

  The ankle's range of motion was evaluated, including dorsiflexion, plantar flexion, eversion, and inversion. Three measurements were taken for each movement, and their mean value was calculated using a GemRed® digital goniometer. The procedure was conducted while ensuring the patient's proper positioning and aligning the instrument with anatomical reference points.

  From enrollment to the end of measurements, approximately one hour

Secondary Outcomes (3)

• Star Excursion Balance Test

  From enrollment to the end of measurements, approximately one hour.

• Hopping Test

  From enrollment to the end of measurements, approximately one hour.

• Vertical Jump Test

  From enrollment to the end of measurements, approximately one hour.

Study Arms (3)

Kinesiotaping Bandage Group

EXPERIMENTAL

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

Behavioral: Innovative Kinesiotaping Bandage Group

Traditional Tape Bandage Group

ACTIVE COMPARATOR

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

Behavioral: Traditional Tape Bandage Group

Placebo Group

PLACEBO COMPARATOR

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

Behavioral: Placebo Bandage Group

Interventions

Innovative Kinesiotaping Bandage Group 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.

Kinesiotaping Bandage Group

Traditional Tape Bandage Group 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.

Traditional Tape Bandage Group

Placebo Bandage Group 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.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Vigo: lead

Study Sites (1)

Pontevedra

Pontevedra, 36004, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 22, 2024
• Study Start: November 27, 2024
• Primary Completion: December 8, 2024
• Study Completion: January 30, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)