Ankle Braces for Ankle Sprains

Overseen By Maria Flory

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Pregnancy, Lower extremity surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 90 minutes

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Enovis High Ankle Sprain Brace treatment?

Research shows that using ankle braces can lead to better functional outcomes and quicker recovery compared to other methods like elastic bandages or tape. Ankle braces have been found to help people move more easily and return to activities faster after an ankle sprain. ^{1 2 3 4 5}

Is the Enovis High Ankle Sprain Brace safe for humans?

Ankle braces, including various designs like sleeve, lace-up, and stirrup, are generally considered safe for stabilizing the ankle after sprains, with some designs being more effective at preventing and treating injuries. They are designed to limit harmful movements without causing significant side effects, such as skin irritation, which can occur with other treatments like taping. ^{5 6 7 8 9}

How does the EXO-L ankle brace treatment differ from other treatments for ankle sprains?

The EXO-L ankle brace is unique because it limits the motion of most sprains without restricting other movements, and it addresses common issues like skin irritation and poor fit in sports shoes that are associated with traditional taping methods. ^{4 7 8 10 11}

What is the purpose of this trial?

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

Research Team

Mikel Joachim, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for individuals who have experienced an ankle sprain or muscle strain. Participants should be able to perform athletic activities like running and cutting. There are no specific inclusion or exclusion criteria provided, so it's assumed that anyone with these conditions can participate unless otherwise specified.

Inclusion Criteria

I have used an ankle brace or tape during sports.

English-speaking

Not currently pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants perform running and cutting activities under different ankle bracing conditions and complete a survey

90 minutes

1 visit (in-person)

Follow-up

Participants are monitored for feedback on comfort and stability of the ankle brace

1 week

Treatment Details

Interventions

• Enovis High Ankle Sprain Brace

Trial Overview The study is testing five different ankle support options: ankle tape, a standard lace-up brace, two types of high ankle-sprain braces (standard and low-profile), and no brace at all. It aims to see how each one affects running and cutting motions and comfort levels during these activities.

Participant Groups

Group I: Running activity Experimental Treatment 5 Interventions

Participants will run for 1 minute at varying speeds

Group II: Dynamic agility task Experimental Treatment 5 Interventions

Participants will complete a 20-yard shuttle test

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Enovis Corporation

Collaborator

Trials

1

Recruited

30+

References

1. England pubmed.ncbi.nlm.nih.gov

Mechanical supports for acute, severe ankle sprain: a pragmatic, multicentre, randomised controlled trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Braced for impact: reducing military paratroopers' ankle sprains using outside-the-boot braces. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Treatment of acute ankle sprain. Comparison of a semi-rigid ankle brace and compression bandage in 73 patients. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of 3 methods of external support for management of acute lateral ankle sprains. [2018]

5. New Zealand pubmed.ncbi.nlm.nih.gov

A systematic review on the treatment of acute ankle sprain: brace versus other functional treatment types. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Hinged ankle braces do not alter knee mechanics during sidestep cutting. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Ankle sprain bracing solutions and future design consideration for civilian and military use. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The Mechanical Functionality of the EXO-L Ankle Brace: Assessment With a 3-Dimensional Computed Tomography Stress Test. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

A Multidimensional Assessment of a Novel Adaptive Versus Traditional Passive Ankle Sprain Protection Systems. [2023]

10. Denmark pubmed.ncbi.nlm.nih.gov

Biomechanical evaluation of different ankle orthoses in a simulated lateral ankle sprain in two different modes. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Effect of Braces on Performance in the Context of Chronic Ankle Instability. [2023]