Clinical trial NCT03901053: Ankle Foot Orthosis Comparative Effect
Official title: Comparative Effect of Commercially Available Custom Dynamic Orthoses (CDOs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Injuries and Disorders
Keywords: Ankle Foot Orthoses
Carbon Fiber
Gait
Adult
Biomechanics
Materials Testing
Physical Performance
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Minneapolis Veterans Affairs Medical Center
name: Walter Reed National Military Medical Center
name: Henry M. Jackson Foundation for the Advancement of Military Medicine
name: Center for Veterans Research and Education
name: University of Delaware
name: Johns Hopkins Bloomberg School of Public Health
First posted: 2019-04-03
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be cast, fit, and tested with each device in question (Reaktiv and PhatBrace AFO). Participants will be randomized to one of two arms (AB or BA) to maximize the likelihood of similarity between groups with respect to a range of anthropometric, demographic and injury related factors. We will use block randomization in groups of 4 to achieve equal randomization between groups over time.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PROMIS Patient reported outcomes for physical function
timeFrame: 3 months
measure: PROMIS Patient reported outcomes for pain interference
timeFrame: 3 months
measure: Activities-Specific Balance Confidence (ABC)
timeFrame: 3 months
measure: Satisfaction with device (OPUS - CSD)
timeFrame: 3 months
measure: Modified Socket Comfort Score (Comfort)
timeFrame: 3 months
measure: Modified Socket Comfort Score (Comfort and Smoothness)
timeFrame: 3 months
measure: Numerical Pain Rating Scale
timeFrame: 3 months
measure: Participant device preference
timeFrame: After 3 months of accomodation with the final device (Crossover study)
measure: Four-square step test (4SST- Timed)
timeFrame: 3 months
measure: Self-selected walking velocity (SSWV - Timed)
timeFrame: 3 months
measure: 10 meter shuttle run (10M Shuttle - Timed)
timeFrame: 3 months
measure: Ankle joint power
timeFrame: 3 months
measure: Center of pressure velocity timing
timeFrame: 3 months
measure: Center of pressure velocity magnitude
timeFrame: 3 months
Secondary outcomes:
measure: PROMIS Patient reported outcomes for satisfaction with participation in social activities
timeFrame: 3 months
measure: Paffenbarger Physical Activity Questionnaire
timeFrame: 3 months
measure: Ankle joint moment
timeFrame: 3 months
Other outcomes:
measure: PROMIS Patient reported outcomes for pain behavior
timeFrame: 3 months
measure: PROMIS Patient reported outcomes for depression
timeFrame: 3 months
measure: PROMIS Patient reported outcomes for satisfaction with participation in social roles
timeFrame: 3 months
measure: Satisfaction with services (OPUS - CSS)
timeFrame: 3 months
measure: Sit to stand 5 times (STS5 - Timed)
timeFrame: 3 months
measure: Timed Stair Ascent (TSA - Timed)
timeFrame: 3 months
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
Study officials:
affiliation: University of Iowa
name: Jason M. Wilken, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: