Image

IM ABLE 2: Injuries Managed With Advanced Bracing for Lower Extremities

IM ABLE 2: Injuries Managed With Advanced Bracing for Lower Extremities

Recruiting
18-80 years
All
Phase N/A

Powered by AI

Overview

The purpose of the study is to test different categories of ankle foot orthoses (AFOs) with patients who have had lower limb salvage, reconstruction or other problems impacting limb function.

Description

The purpose of the study is to test different categories of ankle foot orthoses (AFOs) with patients who have had lower limb salvage, reconstruction or other problems impacting limb function. Some lower limb AFO users will decide later to amputate the affected limb to escape pain and repeated surgery requiring them to use a prosthesis instead. Benefits may include reduced pain and more function from a prosthesis.

This research will allow physicians, physical therapists, orthotists, and researchers to determine what modifications can be made to AFOs to make them more comfortable and usable. Over the course of a year, subjects will test both AFO types; a conventional (standard) AFO and an advanced (energy storing and return) AFO, in a battery of physical tests, community use, and surveys to gain a better understanding of the pros and cons of each.

Subjects will be recruited to participate in research for approximately 18 months. During the first six weeks (up to three weeks on each type of AFO), subjects will be provided with an AFO and given training on how to correctly use and maintain it, to ensure optimal use. Over the following 12 months, there will be monthly assessments including questionnaires, activity monitor uploads, device failures, and interviews to gather information on the subject's experience with AFO use.

Eligibility

Inclusion Criteria:

  • Lower extremity injury of any etiology requiring current use of an AFO
  • Age 18-80 years
  • 100-275 lbs
  • Greater than 1 month of AFO experience
  • Use of an AFO for activities of daily living
  • English or Spanish speaking
  • Able to comply with study procedures

Exclusion Criteria:

  • Body mass less than 100 or greater than 275 lbs.
  • Over 80 years of age
  • Known cognitive impairment (e.g. diagnoses such as moderate/severe traumatic brain injury, dementia)
  • Inability to comply with instructions.
  • Pregnancy
  • Medical conditions that would preclude safe involvement
  • Unable to provide written informed consent.

Study details
    Lower Limb Injury
    Ankle Foot Orthosis (AFO)
    Lower Limb Trauma

NCT07721792

University of South Florida

25 July 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.