Recruiting

Ankle Foot Orthoses

Sponsor:

University of South Florida

Code:

NCT07721792

Conditions

Lower Limb Injury

Ankle Foot Orthosis (AFO)

Lower Limb Trauma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Advanced Ankle Foot Orthosis (AFO)

Conventional Ankle Foot Orthosis (AFO)

Study Details

Brief 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.

Conditions

Lower Limb Injury

Ankle Foot Orthosis (AFO)

Lower Limb Trauma

Study ID

NCT07721792

Start date

Jul 31, 2026

Status verified date

Jul, 2026

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Jan 10, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

Interventions

Advanced Ankle Foot Orthosis (AFO)

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)

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.

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. ]
  • Two-minute Walk Test [ Time Frame: After 3-week accommodation period with device A and after 3-week accommodation period with device B. ]
  • Four-Square-Step-Test [ Time Frame: After 3-week accommodation period with device A and after 3-week accommodation period with device B. ]
  • Activities-Specific Balance Confidence Scale [ Time Frame: After 3-week accommodation period with device A and after 3-week accommodation period with device B. ]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 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) [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Stephanie L Carey, PhD

813-974-5765scarey3@usf.edu

Locations

University of South Florida, Rehabilitation Robotics & Prosthetics Testbed (RRT)

Recruiting

Tampa, Florida, United States, 33620

Contacts

Stephanie L Carey, PhD

813-974-5765scarey3@usf.edu

Principal Investigator:

Stephanie L Carey, PhD

James A. Haley VA Center of Innovation of Disability & Rehab Research

Recruiting

Tampa, Florida, United States, 33637

Contacts

Sam Phillips, PhD

813-558-3995Samuel.Phillips@va.gov

Principal Investigator:

Sam Phillips

VA New York Harbor Healthcare System

Recruiting

New York, New York, United States, 10010

Contacts

Jason Maikos, PhD

212-686-7500jason.maikos@va.gov

Michael Hyre, MS

929-617-0975michael.hyre@va.gov

Principal Investigator:

Jason Maikos, PhD

More Information

Sponsor

University of South Florida

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Ankle foot orthosis (AFO)
  • activity monitor
  • lower limb injury
  • gait
  • activities of daily living
  • lower extremity trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2026-07-23.