RecruitingNot Applicable

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

United States75 participantsStarted 2026-07-31

Plain-language summary

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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Timed Up & Go

Timeframe: After 3-week accommodation period with device A and after 3-week accommodation period with device B.

Two-minute Walk Test

Timeframe: After 3-week accommodation period with device A and after 3-week accommodation period with device B.

Four-Square-Step-Test

Timeframe: After 3-week accommodation period with device A and after 3-week accommodation period with device B.

Activities-Specific Balance Confidence Scale

Timeframe: After 3-week accommodation period with device A and after 3-week accommodation period with device B.

Patient-Reported Outcomes Measurement Information System (PROMIS)

Timeframe: After 3-week accommodation period with device A and after 3-week accommodation period with device B. Monthly for 12 months after accommodation period with device B.

Orthotics and Prosthetics Users' Survey (OPUS)

Timeframe: After 3-week accommodation period with device A and after 3-week accommodation period with device B. Monthly for 12 months after accommodation period with device B.

Trial details

NCT IDNCT07721792

SponsorUniversity of South Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-10

Contact for this trial

Stephanie L Carey, PhD

813-974-5765 scarey3@usf.edu

View on ClinicalTrials.gov More Lower Limb Injury trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Timed Up & Go

Timeframe: After 3-week accommodation period with device A and after 3-week accommodation period with device B.

Two-minute Walk Test

Timeframe: After 3-week accommodation period with device A and after 3-week accommodation period with device B.

Four-Square-Step-Test

Timeframe: After 3-week accommodation period with device A and after 3-week accommodation period with device B.

Activities-Specific Balance Confidence Scale

Timeframe: After 3-week accommodation period with device A and after 3-week accommodation period with device B.

Patient-Reported Outcomes Measurement Information System (PROMIS)

Timeframe: After 3-week accommodation period with device A and after 3-week accommodation period with device B. Monthly for 12 months after accommodation period with device B.

Orthotics and Prosthetics Users' Survey (OPUS)

Timeframe: After 3-week accommodation period with device A and after 3-week accommodation period with device B. Monthly for 12 months after accommodation period with device B.