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

Official title

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

Overview

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.

Interventions

• 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.
• 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 grou

Primary outcome measures

• 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.]

Secondary outcome measures (2)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 3 centers

• University of South Florida, Rehabilitation Robotics & Prosthetics Testbed (RRT) — Tampa
• James A. Haley VA Center of Innovation of Disability & Rehab Research — Tampa
• VA New York Harbor Healthcare System — New York

Identifiers

NCT: NCT07721792 · STUDY009017 · HT9425-25-1-0478

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗