NCT06719609

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

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Aug 2026Mar 2027

First Submitted

Initial submission to the registry

December 2, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
1.7 years until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 29, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

December 2, 2024

Last Update Submit

May 28, 2026

Conditions

Keywords

syndesmosisankle sprainankle bracing

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

EXPERIMENTAL

Participants will run for 1 minute at varying speeds

Other: Ankle tapeOther: Standard lace-up ankle braceOther: Standard high ankle-sprain (HAS) braceOther: Low-profile HAS braceOther: No ankle brace or tape

Dynamic agility task

EXPERIMENTAL

Participants will complete a 20-yard shuttle test

Other: Ankle tapeOther: Standard lace-up ankle braceOther: Standard high ankle-sprain (HAS) braceOther: Low-profile HAS braceOther: No ankle brace or tape

Interventions

The influence of ankle tape on gait biomechanics

Dynamic agility taskRunning activity

The influence of lace-up ankle brace on gait biomechanics

Dynamic agility taskRunning activity

The influence of standard HAS brace on gait biomechanics

Dynamic agility taskRunning activity

The influence of low-profile HAS brace on gait biomechanics

Dynamic agility taskRunning activity

The influence of no ankle tape or brace on gait biomechanics

Dynamic agility taskRunning activity

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

Hyaluronan SynthasesBraces

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

GlucuronosyltransferaseHexosyltransferasesGlycosyltransferasesTransferasesEnzymesEnzymes and CoenzymesOrthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Mikel Joachim, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

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

Locations