Ankle Foot Orthosis Comparative Effect (AFOCE)

Jason Wilken

Status: Completed

Conditions: Foot Injuries and Disorders

Treatments: Device: PhatBrace AFO; Device: Reaktiv AFO

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03901053

201901829

CDMRP-OP170060 (Other Grant/Funding Number)

Details and patient eligibility

About

The proposed effort is designed to support evidence-based practice and optimal care by evaluating how the form, fit and function of two commercially available carbon fiber custom fit braces (Orthoses) influences outcomes following extremity injury. Early data suggests that custom fit carbon fiber braces can significantly improve function following severe lower leg injuries. The proposed study will provide evidence that can be used by clinicians to guide their practice, including care for service members, veterans and civilians who have experienced a high-energy traumatic injury to their lower leg.

Full description

In this research study, adult participants who have sustained a below-the-knee traumatic injury greater than two years ago and are still experiencing deficits including weakness and/or immobility will be assigned to one of two brace sequences (AB or BA). Participants will be randomized to a particular sequence, with an equal chance of getting either order. Participants will be evaluated under 4 conditions: no device, standard of care, and 2 carbon fiber custom dynamic orthoses (CDO), the Reaktiv device from FabTech Systems and the PhatBrace by Bio-Mechanical Composites Inc. Participants will be tested with no device and standard of care at baseline, after 3 months of accommodation to the Reaktiv, and 3 months of accommodation to the PhatBrace. A series of study measures will be performed. The physical performance measures will incorporate tests of agility, balance, speed and lower limb power. Questionnaires will be used to evaluate participant's perceived comfort and smoothness, pain, preference, and semi-structured interviews will be used to fully capture the perspective of the participant. A motion capture system will be used to evaluate walking mechanics, allowing comparisons between conditions. Lower limb forces and body motion will be assessed using computerized motion capture and force plates in the floor, as individuals walk over-ground. Small reflective markers placed on the participant's skin and force measuring plates in the floor will be used. The investigators will also complete mechanical testing of the devices and collect demographic and descriptive data.

Enrollment: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ages: 18-65
• Sustained a function limiting, below the knee, traumatic lower leg injury that occurred greater than two years ago
• Weakness of ankle plantarflexors (<4/5 on MMT), limited pain free ankle motion (DF<10deg or PF<20deg), mechanical pain with loading onto hindfoot/midfoot/forefoot (>4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion or candidate for ankle or hindfoot fusion, AND/OR a candidate for amputation secondary to ankle/foot impairment
• Ability to walk 50 feet without using a cane or crutch
• Ability to walk at a slow to moderate pace
• Able to read and write in English and provide written informed consent

Exclusion criteria

• Pain > 8/10 while walking
• Ankle weakness as a result of spinal cord injury or central nervous system pathology
• Require a knee stabilizing device (i.e. Knee-Ankle Foot Orthosis or Knee Orthosis) to perform daily activities
• Surgery on study limb anticipated in the next 6 months
• Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)
• Nerve, muscle, bone, or other condition limiting function of the contralateral extremity
• BMI greater than 45
• Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
• Pregnancy- Per participant self-report. Due the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

AB

Experimental group

Description:

Participants in this arm will receive the Reaktiv AFO made by FabTech Systems LLC first, then the PhatBrace AFO by Bio-Mechanical Composites Inc. second.

Treatment:

Device: Reaktiv AFO

Device: PhatBrace AFO

BA

Experimental group

Description:

Participants in this arm will receive the PhatBrace AFO by Bio-Mechanical Composites Inc. first, then the Reaktiv AFO made by FabTech Systems LLC second.

Treatment:

Device: Reaktiv AFO

Device: PhatBrace AFO