Lower Limb InjuryIM ABLE 2NCT07721792
IM ABLE 2: Injuries Managed With Advanced Bracing for Lower Extremities
A study testing Advanced Ankle Foot Orthosis (AFO) and Conventional Ankle Foot Orthosis (AFO) in people with Lower Limb Injury and Ankle Foot Orthosis (AFO), run by University of South Florida at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lower Limb Injury, Ankle Foot Orthosis (AFO), Lower Limb Trauma
- What is being tested?
- Advanced Ankle Foot Orthosis (AFO) and Conventional Ankle Foot Orthosis (AFO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Jul 2026to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
VA New York Harbor Healthcare System
New York, New York, 10010
Jason Maikos, PhD, 212-686-7500 ext. 17482, jason.maikos@va.gov
Michael Hyre, MS, 929-617-0975, michael.hyre@va.gov
- Recruiting
University of South Florida, Rehabilitation Robotics & Prosthetics Testbed (RRT)
Tampa, Florida, 33620
Stephanie L Carey, PhD, 813-974-5765, scarey3@usf.edu
Stephanie L Carey, PhD
- Recruiting
James A. Haley VA Center of Innovation of Disability & Rehab Research
Tampa, Florida, 33637
Sam Phillips, PhD, 813-558-3995, Samuel.Phillips@va.gov
Sam Phillips
About this study
Official title: 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.
Read the 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.
- Being tested
- Advanced Ankle Foot Orthosis (AFO), Conventional Ankle Foot Orthosis (AFO)
- Keywords
- Ankle foot orthosis (AFO), activity monitor, lower limb injury, gait, activities of daily living, lower extremity trauma
- Medical subject headings
- Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Ankle Foot Orthosis (AFO)Device
Also called Advanced 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)Device
Also called Conventional AFO, Traditional 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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Ankle Foot Orthosis (AFO) | Active comparator | Limited function; thermoplastic or thermoset material Receives: Device: Conventional Ankle Foot Orthosis (AFO) |
| Advanced Ankle Foot Orthosis (AFO) | Active comparator | Return stored energy; laminated; may include posterior struts; higher activity Receives: Device: Advanced Ankle Foot Orthosis (AFO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: Monthly for 12 months after initial two accommodation and training periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion10 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized cross over with long term observational follow up. Conventional AFO and Advanced AFO. Assess long-term (1 year) patient-reported outcomes of advanced and conventional AFO use in individuals with lower extremity trauma.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Tampa VA Healthcare System, VA New York Harbor Healthcare System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721792
- Sponsor's protocol ID
- STUDY009017
- Other IDs
- HT9425-25-1-0478
- Acronym
- IM ABLE 2
- Status last verified
- Jul 2026
- First submitted
- 26 Mar 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The IM ABLE 2 Study: Long Term Outcomes to Advance Care for Warriors and Veterans Using Advanced Ankle Foot Orthoses
- ClinicalTrials.gov ID
- NCT07721792
- Acronym / sponsor ID
- IM ABLE 2 / STUDY009017
- Keywords
- Ankle foot orthosis (AFO), activity monitor, lower limb injury, gait, activities of daily living, lower extremity trauma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Tampa VA Healthcare System, VA New York Harbor Healthcare System
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 10 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized cross over with long term observational follow up. Conventional AFO and Advanced AFO. Assess long-term (1 year) patient-reported outcomes of advanced and conventional AFO use in individuals with lower extremity trauma.
| Arm | Type | Receives |
|---|---|---|
| Conventional Ankle Foot Orthosis (AFO) | Active comparator | Device: Conventional Ankle Foot Orthosis (AFO)Limited function; thermoplastic or thermoset material |
| Advanced Ankle Foot Orthosis (AFO) | Active comparator | Device: Advanced Ankle Foot Orthosis (AFO)Return stored energy; laminated; may include posterior struts; higher activity |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced Ankle Foot Orthosis (AFO)Also: Advanced AFOSubjects 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. | Device | Advanced Ankle Foot Orthosis (AFO) |
| Conventional Ankle Foot Orthosis (AFO)Also: Conventional AFO, Traditional AFOSubjects 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. | Device | Conventional Ankle Foot Orthosis (AFO) |
Primary outcome
Timed Up & Go
Time frame: After 3-week accommodation period with device A and after 3-week accommodation period with device B.
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.
Two-minute Walk Test
Time frame: After 3-week accommodation period with device A and after 3-week accommodation period with device B.
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).
Four-Square-Step-Test
Time frame: After 3-week accommodation period with device A and after 3-week accommodation period with device B.
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.
Activities-Specific Balance Confidence Scale
Time frame: After 3-week accommodation period with device A and after 3-week accommodation period with device B.
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.
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.
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.
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.
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.
2 secondary outcomes
Preference
Time frame: Before and after each accommodation and training period. At 12 month follow-up.
Activity monitoring
Time frame: Monthly for 12 months after initial two accommodation and training periods
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Ankle Foot Orthosis (AFO) and Conventional Ankle Foot Orthosis (AFO) in people with Lower Limb Injury and Ankle Foot Orthosis (AFO), run by University of South Florida at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie L Carey, PhD (813-974-5765, scarey3@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.