Advanced vs Conventional Ankle Foot Orthoses for Lower Limb Injury
Official title: The IM ABLE 2 Study: Long Term Outcomes to Advance Care for Warriors and Veterans Using Advanced Ankle Foot Orthoses
Run by University of South Florida · NCT07721792 · Data updated 2026-11-12
This study tests whether advanced energy-storing AFOs improve comfort and function for adults with lower limb injuries who use AFOs.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | University of South Florida Academic / other |
| Locations | 3 sites (Tampa, Florida and 2 other locations) |
| Status | Recruiting |
| Started | July 31, 2026 |
| Main results expected | January 10, 2029 |
| Study ends | January 31, 2029 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT07721792 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-80 with a lower limb injury requiring AFO use, at least one month of AFO experience, and English or Spanish speakers who can consent.
✕Probably not a fit
Individuals outside the weight or age range, with cognitive impairment, pregnancy, or conditions precluding safe participation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares two types of ankle foot orthoses in adults with recent or ongoing lower limb issues that require AFO use. Over about 18 months, participants try a conventional AFO and an advanced energy-storing AFO in random or sequential phases, with a year of testing, monthly assessments, and surveys to understand usability, comfort, and functional impact. Training is provided at the start to ensure proper use, and outcomes include physical tests, activity monitoring, and patient-reported experiences. The study aims to identify modifications that improve comfort, stability, and daily living for people needing AFO support.
Why it matters
Potential benefit: If successful, participants may experience reduced pain and improved function with a better-fitting AFO, potentially delaying or avoiding surgery or prosthesis.
How similar studies have gone: Prior research on different AFO designs has shown mixed results, with some improvements in comfort and function using energy-storing designs, but this study adds longer-term, real-world testing.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
University of South Florida, Rehabilitation Robotics & Prosthetics Testbed (RRT)
Tampa, Florida, United States Recruiting -
James A. Haley VA Center of Innovation of Disability & Rehab Research
Tampa, Florida, United States Recruiting -
VA New York Harbor Healthcare System
New York, New York, United States Recruiting
Study contacts
- Study coordinator: Stephanie L Carey, PhD
- Email: scarey3@usf.edu
- Phone: 813-974-5765
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.