Ankle Foot Orthosis Comparative Effect

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Effect of Commercially Available Custom Dynamic Orthoses (CDOs)

Conditions
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Foot Injuries and Disorders

Intervention / Treatment
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* Device: Reaktiv AFO
* Device: PhatBrace AFO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AB<br>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. | Device: Reaktiv AFO<br>* This device is a carbon fiber ankle foot orthosis (brace) that contacts the foot and lower leg. It consists of a foot plate that is designed to protect the foot, a carbon fiber strut on the back that stores and returns energy, and a cuff that goes below the knee. It has a custom geometry and alignment that is specific to the individual.<br>Device: PhatBrace AFO<br>* Although lighter and thinner than the Reaktiv it has a similar overall design. The posterior strut is typically longer and the footplate is thinner, more compliant and less customized. Further, the device is formed into a single piece.<br>|
| Experimental: BA<br>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. | Device: Reaktiv AFO<br>* This device is a carbon fiber ankle foot orthosis (brace) that contacts the foot and lower leg. It consists of a foot plate that is designed to protect the foot, a carbon fiber strut on the back that stores and returns energy, and a cuff that goes below the knee. It has a custom geometry and alignment that is specific to the individual.<br>Device: PhatBrace AFO<br>* Although lighter and thinner than the Reaktiv it has a similar overall design. The posterior strut is typically longer and the footplate is thinner, more compliant and less customized. Further, the device is formed into a single piece.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Patient reported outcomes for physical function | 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. | 3 months | 
| PROMIS Patient reported outcomes for pain interference | 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. | 3 months | 
| Activities-Specific Balance Confidence (ABC) | The ABC provides a standardized evaluation of balance confidence across a range of common daily tasks. | 3 months | 
| Satisfaction with device (OPUS - CSD) | Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Lower scores indicate a better outcome. | 3 months | 
| Modified Socket Comfort Score (Comfort) | Comfort scores range from 0 = most uncomfortable to 10 = most comfortable. | 3 months | 
| Modified Socket Comfort Score (Comfort and Smoothness) | Smoothness scores range from 0 = least smooth to 10 = most smooth. | 3 months | 
| Numerical Pain Rating Scale | Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. | 3 months | 
| Participant device preference | The participant will rank order their preference for their standard of care device, Reaktiv and Phatbrace on a questionnaire. | After 3 months of accomodation with the final device (Crossover study) | 
| Four-square step test (4SST- Timed) | The 4SST is a standardized timed test of balance and agility. | 3 months | 
| Self-selected walking velocity (SSWV - Timed) | SSWV will be assessed using the timed 10 meter walk test. | 3 months | 
| 10 meter shuttle run (10M Shuttle - Timed) | The 10 meter shuttle run is a well-established timed measure of speed. | 3 months | 
| Ankle joint power | Peak ankle joint moment (W/kg) during gait. | 3 months | 
| Center of pressure velocity timing | Timing of peak center of pressure velocity (percent stance) during gait. | 3 months | 
| Center of pressure velocity magnitude | Magnitude of peak center of pressure velocity (m/s) during gait. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Patient reported outcomes for satisfaction with participation in social activities | 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. | 3 months | 
| Paffenbarger Physical Activity Questionnaire | Participants will report their activity using the Paffenbarger Physical Activity Questionnaire. Time spent in each activity category will be recorded. | 3 months | 
| Ankle joint moment | Peak ankle joint moment (Nm/kg) during gait. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankle Foot Orthoses, Carbon Fiber, Gait, Adult, Biomechanics, Materials Testing, Physical Performance