Study Stopped
Waiting for equipment
Enovis High Ankle Sprain Brace Testing
3 other identifiers
interventional
30
1 country
1
Brief 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. Participants will:
- Perform a running activity
- Perform a cutting activity
- Complete a survey
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2024
CompletedFirst Posted
Study publicly available on registry
December 6, 2024
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
May 29, 2026
February 1, 2026
7 months
December 2, 2024
May 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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.
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.
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.
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.
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.
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.
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.
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.
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.
10 minutes
Study Arms (2)
Running activity
EXPERIMENTALParticipants will run for 1 minute at varying speeds
Dynamic agility task
EXPERIMENTALParticipants will complete a 20-yard shuttle test
Interventions
The influence of lace-up ankle brace on gait biomechanics
The influence of standard HAS brace on gait biomechanics
The influence of low-profile HAS brace on gait biomechanics
The influence of no ankle tape or brace on gait biomechanics
Eligibility Criteria
You may qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Enoviscollaborator
- University of Wisconsin, Madisonlead
Study Sites (1)
University of Wisconsin - Madison
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mikel Joachim, PhD
University of Wisconsin, Madison
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2024
First Posted
December 6, 2024
Study Start
August 1, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
May 29, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share