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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the Enovis High Ankle Sprain Brace affects athletic movements such as running and quick direction changes. It also examines the brace's comfort. Participants will try different brace conditions during activities and answer questions about their experience. Ideal candidates have previously worn ankle braces, feel comfortable running on a treadmill, and have not experienced major ankle injuries in the past three months. As an unphased trial, this study allows participants to contribute to innovative sports medicine research and the improvement of future athletic gear.

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 prior data suggests that this ankle brace is safe for athletic activities?

Previous studies have shown that semi-rigid and laced ankle braces significantly reduce first-time and repeat ankle sprains in athletes and military personnel. This indicates that braces like the Enovis High Ankle Sprain Brace are generally safe and comfortable. The current trial primarily examines how this brace affects movement and comfort, rather than potential side effects. This suggests that the brace is expected to be safe, with minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enovis High Ankle Sprain Brace because it offers a new approach to managing ankle sprains by combining stability and mobility. Unlike standard care options like RICE (rest, ice, compression, elevation) or traditional braces, this brace is designed to allow dynamic movement while supporting the injured area. This innovative design can help athletes maintain agility through activities like the 20-yard shuttle test and running at varying speeds, potentially speeding up recovery and maintaining performance.

What evidence suggests that these ankle braces are effective for ankle sprains?

Studies have shown that ankle braces, like the Enovis High Ankle Sprain Brace, can significantly reduce the risk of both first-time and repeat ankle sprains. Research indicates these braces help stabilize the ankle, which is crucial during activities involving quick turns and fast movements. Athletes and military personnel using similar braces have reported fewer ankle injuries. Additionally, wearing ankle braces can improve mobility, making sports and other physical activities easier. This trial will assess the effectiveness of the Enovis High Ankle Sprain Brace during specific activities, such as a 20-yard shuttle test and running at varying speeds, to support and protect the ankle during intense physical activities. ^{1 2 3 5 6}

Who Is on the Research Team?

Mikel Joachim, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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

Shoe size US Men's 7.5-11.5 or Women's 9-13

English-speaking

Not currently pregnant

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. enovis.com enovis.com/education/patient-education/ankle-bracing

Ankle Bracing Scores Big In High School Athletics “Semirigid and laced ankle braces have significantly reduced the incidence of initial and recurrent ankle sprain injuries in athletic and military samples.

2. withpower.com withpower.com/trial/phase-ankle-injuries-11-2024-841f7

Ankle Braces for Ankle Sprains What data supports the effectiveness of the Enovis High Ankle Sprain Brace treatment? Research shows that using ankle braces can lead to better functional ...

3. enovis-medtech.eu enovis-medtech.eu/blog_eu/?p=2331

Managing ankle sprains and chronic ankle instability with ... Medical device company DJO looks at how functional bracing can help manage lateral ankle sprains and chronic ankle instability.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6044595/

THE EFFECT OF BRACING AND BALANCE TRAINING ON ... The purpose of this review was to compare the effect of balance training and bracing in reducing the incidence and relative risk of ankle sprains in ...

5. digitalcommons.otterbein.edu digitalcommons.otterbein.edu/cgi/viewcontent.cgi?article=1144&context=stu_master

Division III Soccer Athlete Ankle Stability In An Ankle Brace ... Essentially, athletes are at an increased risk of experiencing lateral ankle sprains due to the high impact of cutting and turning, which can ...

6. enovis.com enovis.com/our-brands/aircast

Aircast® Braces & Supports Aircast set a new standard of care for sprains and other injuries with patented technology and the use of graduated pneumatic compression.