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

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT07721792
Status
Recruiting
Apply to this trial

Conditions

  • Ankle Foot Orthosis (AFO)
  • Lower Limb Injury
  • Lower Limb Trauma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Advanced Ankle Foot Orthosis (AFO) — DEVICE
    Subjects will be initially fit with the AFO category they do not use on a daily basis to ensure they have both AFO categories for the study. These "advanced" AFOs have been developed to offer energy-storing-and-returning (ESR) properties to the user. Advanced Ankle Foot Orthoses include designs that are widely believed to return stored energy in late stance. These designs are laminated and may include posterior struts.
  • Conventional Ankle Foot Orthosis (AFO) — DEVICE
    Subjects will be initially fit with the AFO category they do not use on a daily basis to ensure they have both AFO categories for the study. Conventional Ankle Foot Orthoses have been more commonly used in past decades. AFOs within the conventional category generally include designs that will not return stored energy in late stance. These designs may vary in material construction and componentry. For instance, mechanical joints can be incorporated but do not have to be for inclusion in this group. AFOs in this category may be thermoplastic materials or thermoset laminate. The devices may be off-the-shelf or custom molded to the patient.

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Jan 10, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Conventional Ankle Foot Orthosis (AFO)
    Limited function; thermoplastic or thermoset material
  • Active Comparator: Advanced Ankle Foot Orthosis (AFO)
    Return stored energy; laminated; may include posterior struts; higher activity

Primary Outcome Measure

Timed Up & Go [ Time Frame: After 3-week accommodation period with device A and after 3-week accommodation period with device B. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
James A. Haley VA Center of Innovation of Disability & Rehab ResearchTampaFlorida33637
Sam Phillips, PhD
[email protected]
813-558-3995
Sam Phillips (PRINCIPAL_INVESTIGATOR)
University of South Florida, Rehabilitation Robotics & Prosthetics Testbed (RRT)TampaFlorida33620
Stephanie L Carey, PhD
[email protected]
813-974-5765
Stephanie L Carey, PhD (PRINCIPAL_INVESTIGATOR)
VA New York Harbor Healthcare SystemNew YorkNew York10010
Jason Maikos, PhD
[email protected]
212-686-7500
Michael Hyre, MS
[email protected]
929-617-0975
Jason Maikos, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

By research site
James A. Haley VA Center of Innovation of Disability & Rehab Research· Tampa, FLUniversity of South Florida, Rehabilitation Robotics & Prosthetics Testbed (RRT)· Tampa, FLVA New York Harbor Healthcare System· New York, NY

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