IM ABLE 2: Testing Advanced Bracing for Lower Leg Injuries
This study, called IM ABLE 2, is looking at how different types of ankle foot orthoses (AFOs) – special braces for your ankle and foot – help people with lower leg injuries. You would try out two kinds of AFOs: a conventional AFO (a standard type) and an advanced AFO (designed to store and return energy). The goal is to see which AFO helps you move better and reduces pain. This study is for adults aged 18-80 who currently use an AFO for daily activities due to a lower leg injury. Researchers will measure your walking ability and balance to understand the benefits of each AFO. The study aims to enroll 75 participants, but its current status is unclear.
- Study design
- This interventional study plans to enroll 75 participants. You will test both a conventional AFO and an advanced AFO.
- What's involved
- You will participate for approximately 18 months, including a six-week period to learn how to use each AFO. Monthly assessments, questionnaires, and interviews will gather information on your experience.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
IM ABLE 2: Injuries Managed With Advanced Bracing for Lower Extremities
At a glance
Conditions
Where it's being run
3 sites across 2 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Timed Up & GoAfter 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 TestAfter 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-TestAfter 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 ScaleAfter 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)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)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.