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

The IM ABLE 2 Study: Long Term Outcomes to Advance Care for Warriors and Veterans Using Advanced Ankle Foot Orthoses

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.

Study Overview

• Status: Recruiting
• Conditions: Lower Limb Injury; Ankle Foot Orthosis (AFO); Lower Limb Trauma
• Intervention / Treatment: Device: Conventional Ankle Foot Orthosis (AFO); Device: Advanced Ankle Foot Orthosis (AFO)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie L Carey, PhD; Phone Number: 813-974-5765; Email: scarey3@usf.edu

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33620
      • Recruiting
      • University of South Florida, Rehabilitation Robotics & Prosthetics Testbed (RRT)
      • Contact: Stephanie L Carey, PhD; Phone Number: 813-974-5765; Email: scarey3@usf.edu
      • Principal Investigator: Stephanie L Carey, PhD
    • Tampa, Florida, United States, 33637
      • Recruiting
      • James A. Haley VA Center of Innovation of Disability & Rehab Research
      • Contact: Sam Phillips, PhD; Phone Number: 813-558-3995; Email: Samuel.Phillips@va.gov
      • Principal Investigator: Sam Phillips
  • New York
    • New York, New York, United States, 10010
      • Recruiting
      • VA New York Harbor Healthcare System
      • Principal Investigator: Jason Maikos, PhD
      • Contact: Jason Maikos, PhD; Phone Number: 17482 212-686-7500; Email: jason.maikos@va.gov
      • Contact: Michael Hyre, MS; Phone Number: 929-617-0975; Email: michael.hyre@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Ankle Foot Orthosis (AFO); Limited function; thermoplastic or thermoset material	Device: 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.; Other Names: Conventional AFO; Traditional AFO
Active Comparator: Advanced Ankle Foot Orthosis (AFO); Return stored energy; laminated; may include posterior struts; higher activity	Device: 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.; Other Names: Advanced AFO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed Up & Go	The Timed Up& Go (TUG) assesses mobility. In this test, subjects are timed while they rise from a chair, walk 3m, turn around, return to the chair and sit down again. Subjects are usually permitted to use a walking aid, but not to use physical assistance.	After 3-week accommodation period with device A and after 3-week accommodation period with device B.
Two-minute Walk Test	The Two-minute Walk Test (2MWT) assesses walking ability. Subjects will be asked to walk the greatest distance they can in 2 minutes while walking a 15.2m 'out and back' course until asked to stop. The distance walked will be recorded as will the post-test rate of perceived exertion (6-20 Borg RPE scale).	After 3-week accommodation period with device A and after 3-week accommodation period with device B.
Four-Square-Step-Test	The Four-Square-Step-Test is a balance and agility test where the patient changes direction quickly while maintaining balance. A 1-inch-high obstacle in the shape of a Maltese cross is placed on the floor. The patient is instructed to begin in the back, left quadrant then to move 1) forward, 2) sideways right, 3) backward, then 4) sideways left, then to move in the reverse direction back to the original square. They move as fast as possible through their movement progression while always keeping one foot on the floor.	After 3-week accommodation period with device A and after 3-week accommodation period with device B.
Activities-Specific Balance Confidence Scale	The Activities-Specific Balance Confidence Scale (ABC Scale) is a 16-item self-report tool that measures an individual's confidence in performing daily activities without losing balance or feeling unsteady. Participants rate their confidence for each activity on a 0% to 100% scale where 0% indicates no confidence and 100% indicates complete confidence.	After 3-week accommodation period with device A and after 3-week accommodation period with device B.
Patient-Reported Outcomes Measurement Information System (PROMIS)	The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PROMIS-PI) is a standardized, self-reported tool designed to assess the extent to which pain disrupts a person's daily activities and quality of life. The PROMIS-PI evaluates the impact of pain on social, physical, emotional and cognitive functioning. Responses are rated on a 5-point scale from "never" to "very much" regarding how pain interfered with activities in the past week.	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)	The OPUS is a self-report questionnaire consisting of five modules. The following four modules related to the lower extremity will be used: 1) Lower Extremity Functional Status Measure, 2) Health Related Quality of Life Index, 3) Satisfaction with Devices and 4) Satisfaction with Services. The first two modules are based on a five-point Likert scale and nominal Yes/No scale while the latter two use a four-point Likert scale. Higher scores indicate better outcomes.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preference	Interviews with participants will be used to identify overall preference and device preference for different activities. Interviews will also ask about the specific needs, preferences, challenges, and limitations of using each device.	Before and after each accommodation and training period. At 12 month follow-up.
Activity monitoring	The activity monitors will measure active and sedentary periods of behavior. Specific variables estimated will include - time spent sitting, standing, stepping, time spent in sedentary, light and moderate-to-vigorous intensity activity, time spent in prolonged sitting bouts (e.g., sitting bouts > 30 min, > 60 min etc.), time spent in bouts of moderate-to-vigorous intensity (e.g., > 10 minute bouts, i.e., activity bouts known to improve health), number of steps per day and number of sit-to-stand transitions per sedentary time.	Monthly for 12 months after initial two accommodation and training periods

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: VA New York Harbor Healthcare System; Tampa VA Healthcare System

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): January 10, 2029
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: gait; activities of daily living; activity monitor; lower limb injury; Ankle foot orthosis (AFO); lower extremity trauma
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries
• Other Study ID Numbers: STUDY009017; HT9425-25-1-0478 (Other Grant/Funding Number: US Army Medical Research & Material Command)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes