Ankle Foot Orthosis Comparative Effect
- Conditions
- Foot Injuries and Disorders
- Interventions
- Device: Reaktiv AFODevice: PhatBrace AFO
- Registration Number
- NCT03901053
- Lead Sponsor
- Jason Wilken
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description AB Reaktiv AFO 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. BA PhatBrace AFO 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. AB PhatBrace AFO 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. BA Reaktiv AFO 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.
- Primary Outcome Measures
Name Time Method PROMIS Patient reported outcomes for physical function 3 months The Patient Reported Outcome Information System (PROMIS) physical function Computer Adaptive Test (CAT) is a computerized assessment measuring physical function. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.
Activities-Specific Balance Confidence (ABC) 3 months The ABC provides a standardized evaluation of balance confidence across a range of common daily tasks.
Numerical Pain Rating Scale 3 months Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Participant device preference After 3 months of accomodation with the final device (Crossover study) The participant will rank order their preference for their standard of care device, Reaktiv and Phatbrace on a questionnaire.
Four-square step test (4SST- Timed) 3 months The 4SST is a standardized timed test of balance and agility.
Center of pressure velocity magnitude 3 months Magnitude of peak center of pressure velocity (m/s) during gait.
Satisfaction with device (OPUS - CSD) 3 months Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Lower scores indicate a better outcome.
Center of pressure velocity timing 3 months Timing of peak center of pressure velocity (percent stance) during gait.
PROMIS Patient reported outcomes for pain interference 3 months The Patient Reported Outcome Information System (PROMIS) pain interference Computer Adaptive Test (CAT) is a computerized assessment measuring pain interference. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.
Modified Socket Comfort Score (Comfort) 3 months Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Modified Socket Comfort Score (Comfort and Smoothness) 3 months Smoothness scores range from 0 = least smooth to 10 = most smooth.
10 meter shuttle run (10M Shuttle - Timed) 3 months The 10 meter shuttle run is a well-established timed measure of speed.
Ankle joint power 3 months Peak ankle joint moment (W/kg) during gait.
Self-selected walking velocity (SSWV - Timed) 3 months SSWV will be assessed using the timed 10 meter walk test.
- Secondary Outcome Measures
Name Time Method Paffenbarger Physical Activity Questionnaire 3 months Participants will report their activity using the Paffenbarger Physical Activity Questionnaire. Time spent in each activity category will be recorded.
PROMIS Patient reported outcomes for satisfaction with participation in social activities 3 months The Patient Reported Outcome Information System (PROMIS) satisfaction with participation in social activities Computer Adaptive Test (CAT) is a computerized assessment measuring satisfaction with participation in social activities. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents more of the measured variable than the population average.
Ankle joint moment 3 months Peak ankle joint moment (Nm/kg) during gait.
Trial Locations
- Locations (3)
Minneapolis VA Health Care System
🇺🇸Minneapolis, Minnesota, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States