Athletes in Cutting SportsNCT06719609
Enovis High Ankle Sprain Brace Testing
A study testing Ankle tape, Standard lace-up ankle brace and Standard high ankle-sprain (HAS) brace in people with Athletes in Cutting Sports, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a new ankle brace impacts athletic motions. The main questions it aims to answer are: Does it impact motions such as running and cutting? Is it comfortable? Researchers will compare 5 ankle bracing conditions. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletes in Cutting Sports
- What is being tested?
- Ankle tape, Standard lace-up ankle brace and Standard high ankle-sprain (HAS) brace
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to May 2027
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 40 at the time of data collection
- English-speaking
- Not currently pregnant
- No history of lower extremity surgery or chronic ankle instability
- No ankle injuries that required medical attention or ≥ 7 days of modified physical activity within the last 3 months
- Currently cleared for all physical activity
Show all 9Show fewer
- Comfortable running on a treadmill for 10 minutes at a self-selected pace
- Have prior experience wearing an ankle brace and / or ankle tape during sport activities
- Shoe size US Men's 7.5-11.5 or Women's 9-13
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53705
About this study
The goal of this clinical trial is to learn if a new ankle brace impacts athletic motions. The main questions it aims to answer are:
- Does it impact motions such as running and cutting?
- Is it comfortable?
Researchers will compare 5 ankle bracing conditions.
Participants will:
- Perform a running activity
- Perform a cutting activity
- Complete a survey
- Conditions
- Athletes in Cutting Sports
- Being tested
- Ankle tape, Standard lace-up ankle brace, Standard high ankle-sprain (HAS) brace, Low-profile HAS brace, No ankle brace or tape
- Keywords
- syndesmosis, ankle sprain, ankle bracing
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle tapeOther
The influence of ankle tape on gait biomechanics
Standard lace-up ankle braceOther
The influence of lace-up ankle brace on gait biomechanics
Standard high ankle-sprain (HAS) braceOther
The influence of standard HAS brace on gait biomechanics
Low-profile HAS braceOther
The influence of low-profile HAS brace on gait biomechanics
No ankle brace or tapeOther
The influence of no ankle tape or brace on gait biomechanics
| Study group | Role | What they receive |
|---|---|---|
| Running activity | Experimental | Participants will run for 1 minute at varying speeds Receives: Other: Ankle tape; Other: Standard lace-up ankle brace; Other: Standard high ankle-sprain (HAS) brace; Other: Low-profile HAS brace; Other: No ankle brace or tape |
| Dynamic agility task | Experimental | Participants will complete a 20-yard shuttle test Receives: Other: Ankle tape; Other: Standard lace-up ankle brace; Other: Standard high ankle-sprain (HAS) brace; Other: Low-profile HAS brace; Other: No ankle brace or tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort of bracing condition - treadmill activity
Participants will rate the comfort of each bracing condition. The comfort scale ranges from completely uncomfortable to completely comfortable.
Measured: 90 minutes
Movement ability - treadmill activity
Participants will rate how each bracing condition impacted their ability to move. Movement scale ranges from no impact to completely changed my movement.
Measured: 90 minutes
Ankle stability - treadmill activity
Participants will rate how stable their ankle felt in each bracing condition. Stability scale ranges from very stable to completely unstable.
Measured: 90 minutes
Likelihood of use during sport - treadmill activity
Participants will rate how likely they are to use each bracing condition during their sport. Likelihood scale ranges from extremely unlikely to extremely likely.
Measured: 90 minutes
Comfort of bracing condition - shuttle test
Participants will rate the comfort of each bracing condition. The comfort scale ranges from completely uncomfortable to completely comfortable.
Measured: 90 minutes
Movement ability - shuttle test
Participants will rate how each bracing condition impacted their ability to move. Movement scale ranges from no impact to completely changed my movement.
Measured: 90 minutes
Ankle stability - shuttle test
Participants will rate how stable their ankle felt in each bracing condition. Stability scale ranges from very stable to completely unstable.
Measured: 90 minutes
Likelihood of use during sport - shuttle test
Participants will rate how likely they are to use each bracing condition during their sport. Likelihood scale ranges from extremely unlikely to extremely likely.
Measured: 90 minutes
Ankle joint stability
Ultrasound will be used during Reverse Anterolateral Drawer Test. The examiner will hold the participant's foot stable against the exam table and will use their other hand to translate the participant's tibia/shank posteriorly. A second examiner will record an US video of the ankle joint during this test to measure the relative translation between the talus and the fibula. These procedures will be repeated on the other limb.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study startOct 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Why it stopped: Waiting for equipment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletes in Cutting SportsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Enovis
- Responsible party
- Sponsor
- Investigators
- Mikel Joachim, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719609
- Sponsor's protocol ID
- 2024-1684
- Other IDs
- Protocol Version 5/27/2025, A536130
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enovis High Ankle Sprain Brace Testing
- ClinicalTrials.gov ID
- NCT06719609
- Acronym / sponsor ID
- 2024-1684
- Conditions
- Athletes in Cutting Sports
- Keywords
- syndesmosis, ankle sprain, ankle bracing
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Waiting for equipment
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Enovis
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 Dec 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.
The goal of this clinical trial is to learn if a new ankle brace impacts athletic motions. The main questions it aims to answer are:
- Does it impact motions such as running and cutting?
- Is it comfortable?
Researchers will compare 5 ankle bracing conditions.
Participants will:
- Perform a running activity
- Perform a cutting activity
- Complete a survey
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Running activity | Experimental | Other: Ankle tape, Other: Standard lace-up ankle brace, Other: Standard high ankle-sprain (HAS) brace, Other: Low-profile HAS brace, Other: No ankle brace or tapeParticipants will run for 1 minute at varying speeds |
| Dynamic agility task | Experimental | Other: Ankle tape, Other: Standard lace-up ankle brace, Other: Standard high ankle-sprain (HAS) brace, Other: Low-profile HAS brace, Other: No ankle brace or tapeParticipants will complete a 20-yard shuttle test |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18 to 40 at the time of data collection
- English-speaking
- Not currently pregnant
- No history of lower extremity surgery or chronic ankle instability
- No ankle injuries that required medical attention or ≥ 7 days of modified physical activity within the last 3 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ankle tapeThe influence of ankle tape on gait biomechanics | Other | Dynamic agility task, Running activity |
| Standard lace-up ankle braceThe influence of lace-up ankle brace on gait biomechanics | Other | Dynamic agility task, Running activity |
| Standard high ankle-sprain (HAS) braceThe influence of standard HAS brace on gait biomechanics | Other | Dynamic agility task, Running activity |
| Low-profile HAS braceThe influence of low-profile HAS brace on gait biomechanics | Other | Dynamic agility task, Running activity |
| No ankle brace or tapeThe influence of no ankle tape or brace on gait biomechanics | Other | Dynamic agility task, Running activity |
Primary outcome
Comfort of bracing condition - treadmill activity
Time frame: 90 minutes
Participants will rate the comfort of each bracing condition. The comfort scale ranges from completely uncomfortable to completely comfortable.
Movement ability - treadmill activity
Time frame: 90 minutes
Participants will rate how each bracing condition impacted their ability to move. Movement scale ranges from no impact to completely changed my movement.
Ankle stability - treadmill activity
Time frame: 90 minutes
Participants will rate how stable their ankle felt in each bracing condition. Stability scale ranges from very stable to completely unstable.
Likelihood of use during sport - treadmill activity
Time frame: 90 minutes
Participants will rate how likely they are to use each bracing condition during their sport. Likelihood scale ranges from extremely unlikely to extremely likely.
Comfort of bracing condition - shuttle test
Time frame: 90 minutes
Participants will rate the comfort of each bracing condition. The comfort scale ranges from completely uncomfortable to completely comfortable.
Movement ability - shuttle test
Time frame: 90 minutes
Participants will rate how each bracing condition impacted their ability to move. Movement scale ranges from no impact to completely changed my movement.
Ankle stability - shuttle test
Time frame: 90 minutes
Participants will rate how stable their ankle felt in each bracing condition. Stability scale ranges from very stable to completely unstable.
Likelihood of use during sport - shuttle test
Time frame: 90 minutes
Participants will rate how likely they are to use each bracing condition during their sport. Likelihood scale ranges from extremely unlikely to extremely likely.
Ankle joint stability
Time frame: 10 minutes
Ultrasound will be used during Reverse Anterolateral Drawer Test. The examiner will hold the participant's foot stable against the exam table and will use their other hand to translate the participant's tibia/shank posteriorly. A second examiner will record an US video of the ankle joint during this test to measure the relative translation between the talus and the fibula. These procedures will be repeated on the other limb.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Yes
Related trials for Athletes in Cutting Sports
RecruitingObservational study
Arabic Version of Marx Activity Rating and Knee Stability in Sports/Cutting-Pivoting Ability Scales
Anterior Cruciate Ligament, Injuries
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.
Mikel Joachim, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle tape, Standard lace-up ankle brace and Standard high ankle-sprain (HAS) brace in people with Athletes in Cutting Sports, run by University of Wisconsin, Madison at 1 site in United States.
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 9 inclusion and 0 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: paused, as of the sponsor's last update on 14 Aug 2026. 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 United States. 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?
Results are not available in the source record.
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?
Comfort of bracing condition - treadmill activity (time frame: 90 minutes). The study lists 9 primary outcomes in all. 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 14 Aug 2026.