Enovis High Ankle Sprain Brace Testing

May 28, 2026 updated by: University of Wisconsin, Madison

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 Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin - Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Running activity
Participants will run for 1 minute at varying speeds
Other: Ankle tape
The influence of ankle tape on gait biomechanics
Other: Standard lace-up ankle brace
The influence of lace-up ankle brace on gait biomechanics
Other: Standard high ankle-sprain (HAS) brace
The influence of standard HAS brace on gait biomechanics
Other: Low-profile HAS brace
The influence of low-profile HAS brace on gait biomechanics
Other: No ankle brace or tape
The influence of no ankle tape or brace on gait biomechanics
Experimental: Dynamic agility task
Participants will complete a 20-yard shuttle test
Other: Ankle tape
The influence of ankle tape on gait biomechanics
Other: Standard lace-up ankle brace
The influence of lace-up ankle brace on gait biomechanics
Other: Standard high ankle-sprain (HAS) brace
The influence of standard HAS brace on gait biomechanics
Other: Low-profile HAS brace
The influence of low-profile HAS brace on gait biomechanics
Other: No ankle brace or tape
The influence of no ankle tape or brace on gait biomechanics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 minutes
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.
90 minutes
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.
90 minutes
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.
90 minutes
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.
90 minutes
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.
90 minutes
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.
90 minutes
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.
90 minutes
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.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

Enovis

Investigators

  • Principal Investigator: Mikel Joachim, PhD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Actual)

December 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-1684
  • A536130 (Other Identifier: UW Madison)
  • Protocol Version 5/27/2025 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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