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
2 other identifiers
interventional
75
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2026
CompletedFirst Posted
Study publicly available on registry
July 23, 2026
CompletedStudy Start
First participant enrolled
July 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2029
July 23, 2026
July 1, 2026
2.4 years
March 26, 2026
July 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (2)
Preference
Before and after each accommodation and training period. At 12 month follow-up.
Activity monitoring
Monthly for 12 months after initial two accommodation and training periods
Study Arms (2)
Conventional Ankle Foot Orthosis (AFO)
ACTIVE COMPARATORLimited function; thermoplastic or thermoset material
Advanced Ankle Foot Orthosis (AFO)
ACTIVE COMPARATORReturn stored energy; laminated; may include posterior struts; higher activity
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Lower extremity injury of any etiology requiring current use of an AFO
- Age 18-80 years
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Floridalead
- Tampa VA Healthcare Systemcollaborator
- VA New York Harbor Healthcare Systemcollaborator
Study Sites (3)
University of South Florida, Rehabilitation Robotics & Prosthetics Testbed (RRT)
Tampa, Florida, 33620, United States
James A. Haley VA Center of Innovation of Disability & Rehab Research
Tampa, Florida, 33637, United States
VA New York Harbor Healthcare System
New York, New York, 10010, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Statistician
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2026
First Posted
July 23, 2026
Study Start
July 31, 2026
Primary Completion (Estimated)
January 10, 2029
Study Completion (Estimated)
January 31, 2029
Last Updated
July 23, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share