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Suspended

NCT Number: NCT06719609

Enovis High Ankle Sprain Brace Testing

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

Why the study stopped: Waiting for equipment
Suspended

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Key information

Conditions

Athletes in Cutting Sports Ankle Injuries Leg Injuries Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ankle tape

Other

The influence of ankle tape on gait biomechanics

Standard lace-up ankle brace

Other

The influence of lace-up ankle brace on gait biomechanics

Standard high ankle-sprain (HAS) brace

Other

The influence of standard HAS brace on gait biomechanics

Low-profile HAS brace

Other

The influence of low-profile HAS brace on gait biomechanics

No ankle brace or tape

Other

The influence of no ankle tape or brace on gait biomechanics

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Enovis

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 6, 2024
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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