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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
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.
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.
University of Iowa
Iowa City, Iowa, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States
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.
Time frame: 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.
Time frame: 3 months
Activities-Specific Balance Confidence (ABC)
The Activities-Specific Balance Confidence (ABC) scale provides a standardized evaluation of balance confidence across a range of common daily tasks. Higher scores indicate more confidence, with 0 = no confidence and 100 = full confidence.
Time frame: 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). Higher scores indicate a better outcome.
Time frame: 3 months
Modified Socket Comfort Score (Comfort)
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Time frame: 3 months
Modified Socket Comfort Score (Comfort and Smoothness)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Smoothness scores range from 0 = least smooth to 10 = most smooth.
Time frame: 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.
Time frame: 3 months
Participant Device Preference
The participant will rank order their preference for the Reaktiv and Phatbrace on a questionnaire.
Time frame: 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. Measured in seconds with lower scores indicating better balance and agility.
Time frame: 3 months
Self-selected Walking Velocity (SSWV - Timed)
SSWV will be assessed using the timed 10 meter walk test. Measured in seconds.
Time frame: 3 months
10 Meter Shuttle Run (10M Shuttle - Timed)
The 10 meter shuttle run is a well-established timed measure of speed. Measured in seconds.
Time frame: 3 months
Ankle Joint Power
Peak ankle joint moment (W/kg) during gait.
Time frame: 3 months
Center of Pressure Velocity Timing
Timing of peak center of pressure velocity (percent stance) during gait.
Time frame: 3 months
Center of Pressure Velocity Magnitude
Magnitude of peak center of pressure velocity (m/s) during gait.
Time frame: 3 months
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.
Time frame: 3 months
Paffenbarger Physical Activity Questionnaire
Participants will report their physical activity using the Paffenbarger Physical Activity Questionnaire. Average hours of vigorous activity completed during the week and during the weekend will be recorded separately. Participants completed this questionnaire at the beginning of the study prior and reported baseline physical activity without wearing either CDO.
Time frame: Baseline
Ankle Joint Moment
Peak ankle joint moment (Nm/kg) during gait.
Time frame: 3 months