AthletesNCT06701994
Efficacy of an Innovative Kinesiotaping Bandage Compared to Traditional Tape in Stabilising Ankle Inversion and Plantar Flexion in Triathletes.
A study testing Innovative Kinesiotaping Bandage Group and Traditional Tape Bandage Group in people with Athletes, run by University of Vigo at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athletes
- What is being tested?
- Innovative Kinesiotaping Bandage Group and Traditional Tape Bandage Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 27 Nov 2024to 30 Jan 2025
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult men (over 18 years old).
- Federated triathletes.
- No medical conditions or pathologies that could affect the measurements.
- Signed informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Innovative Kinesiotaping Bandage Compared to Traditional Tape in Stabilising Ankle Inversion and Plantar Flexion in Triathletes: A Triple-Blind Experimental Study
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:
Read more
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
- Being tested
- Innovative Kinesiotaping Bandage Group, Traditional Tape Bandage Group, Placebo Bandage Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative Kinesiotaping Bandage GroupBehavioural
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 GroupBehavioural
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 Bandage GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Traditional Tape Bandage Group |
| Placebo Group | Placebo comparator | An opaque stocking is placed on the participant's ankle. Receives: Behavioral: Placebo Bandage Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of measurements, approximately one hour
Secondary outcomes (3)
Star Excursion Balance Test
Dynamic postural control was evaluated through a test in which participants, while maintaining balance on their dominant foot, had to reach the furthest point in each of the eight directions of a star. Distances were measured from the centre of the supporting foot to the tip of the opposite foot. To obtain a general indicator of dynamic balance performance, the average of the distances reached in all directions was calculated.
Measured: From enrollment to the end of measurements, approximately one hour.
Hopping Test
The Hopping Test evaluates dynamic balance and agility on uneven surfaces. Participants perform a hopping sequence over elevated squares tilted at a 15° angle. The task involves completing a course by hopping back and forth across eight marked squares as quickly as possible, maintaining balance and control. The total time required to complete the course is recorded as the performance outcome. This test assesses functional stability and proprioception under challenging conditions.
Measured: From enrollment to the end of measurements, approximately one hour.
Vertical Jump Test
The Vertical Jump Test measures explosive lower-limb strength and power. Participants perform two types of jumps: a countermovement jump and a squat jump from a static position. A force platform records flight time and calculates jump height for each attempt. The test evaluates the participant's ability to generate power in vertical motion, providing insights into muscular performance and functional capacity. Results are analysed to compare performance across conditions.
Measured: From enrollment to the end of measurements, approximately one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start27 Nov 2024
- Primary completion8 Dec 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthletesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Hernandez-Lucas, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701994
- Sponsor's protocol ID
- Vendaje Ogando
- Status last verified
- Mar 2025
- First submitted
- 19 Nov 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Innovative Kinesiotaping Bandage Compared to Traditional Tape in Stabilising Ankle Inversion and Plantar Flexion in Triathletes: A Triple-Blind Experimental Study
- ClinicalTrials.gov ID
- NCT06701994
- Acronym / sponsor ID
- Vendaje Ogando
- Conditions
- Athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 8 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 22 Nov 2024 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesiotaping Bandage Group | Experimental | Behavioral: Innovative Kinesiotaping Bandage GroupA bandage using kinesiotape will be applied to the participant's ankle directly on the skin and covered with an opaque stocking. |
| Traditional Tape Bandage Group | Active comparator | Behavioral: Traditional Tape Bandage GroupA bandage will be applied to the participant's ankle using kinesiotape directly on the skin and covered with an opaque stocking. |
| Placebo Group | Placebo comparator | Behavioral: Placebo Bandage GroupAn opaque stocking is placed on the participant's ankle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult men (over 18 years old).
- Federated triathletes.
- No medical conditions or pathologies that could affect the measurements.
- Signed informed consent.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Innovative Kinesiotaping Bandage GroupThis 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. | Behavioural | Kinesiotaping Bandage Group |
| Traditional Tape Bandage GroupParticipants 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. | Behavioural | Traditional Tape Bandage Group |
| Placebo Bandage GroupParticipants 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. | Behavioural | Placebo Group |
Primary outcome
Ankle Goniometry
Time frame: From enrollment to the end of measurements, approximately one hour
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.
3 secondary outcomes
Star Excursion Balance Test
Time frame: From enrollment to the end of measurements, approximately one hour.
Hopping Test
Time frame: From enrollment to the end of measurements, approximately one hour.
Vertical Jump Test
Time frame: From enrollment to the end of measurements, approximately one hour.
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 28 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innovative Kinesiotaping Bandage Group and Traditional Tape Bandage Group in people with Athletes, run by University of Vigo at 1 site in Spain.
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 4 inclusion and 6 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 28 Mar 2025. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Ankle Goniometry (time frame: From enrollment to the end of measurements, approximately one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2025.