Back to resultsAnkle Foot Orthosis Comparative Effect (AFOCE)
Primary Purpose
Foot Injuries and Disorders
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reaktiv AFO
PhatBrace AFO
Sponsored by
About this trial
This is an interventional treatment trial for Foot Injuries and Disorders focused on measuring Ankle Foot Orthoses, Carbon Fiber, Gait, Adult, Biomechanics, Materials Testing, Physical Performance
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of pregnant individuals and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study.
Sites / Locations
- University of IowaRecruiting
- Walter Reed National Military Medical Center
- Minneapolis VA Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AB
BA
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
PROMIS Patient reported outcomes for pain behavior
The Patient Reported Outcome Information System (PROMIS) pain behavior Computer Adaptive Test (CAT) is a computerized assessment measuring pain behavior. 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.
PROMIS Patient reported outcomes for depression
The Patient Reported Outcome Information System (PROMIS) depression Computer Adaptive Test (CAT) is a computerized assessment measuring depression. 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.
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.
PROMIS Patient reported outcomes for satisfaction with participation in social roles
The Patient Reported Outcome Information System (PROMIS) satisfaction with participation in social roles Computer Adaptive Test (CAT) is a computerized assessment measuring satisfaction with participation in social roles. 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.
Four-square step test (4SST- Timed)
The 4SST is a standardized timed test of balance and agility.
Self-selected walking velocity (SSWV - Timed)
SSWV will be assessed using the timed 10 meter walk test.
Single leg stance test with eyes open on foam (SLSEOF - Timed)
SLSEOF test will be used to assess balance while standing on one leg on a closed-cell foam pad.
Sit to stand 5 times (STS5 - Timed)
STS5 is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to stand up and sit down 5 times as fast as possible.
10 meter shuttle run (10M Shuttle - Timed)
The 10 meter shuttle run is a well-established timed measure of speed.
Timed Stair Ascent (TSA - Timed)
The timed stair ascent test is a measure of mobility, agility, and lower limb muscle strength. Participants are instructed to ascend a flight of 12 steps as quickly and safely as possible while contacting every step.
Activities-Specific Balance Confidence (ABC)
The ABC provides a standardized evaluation of balance confidence across a range of common daily tasks.
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.
Satisfaction with services (OPUS - CSS)
Satisfaction with services will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Services Score (10-50). Lower scores indicate a better outcome.
Modified Socket Comfort Score (Comfort and Smoothness)
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable, and from 0 = least smooth to 10 = most smooth.
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.
Ankle joint moment
Peak ankle joint moment (Nm/kg) during gait.
Ankle joint power
Peak ankle joint moment (W/kg) during gait.
Center of pressure velocity timing
Timing of peak center of pressure velocity (percent stance) during gait.
Center of pressure velocity magnitude
Magnitude of peak center of pressure velocity (m/s) during gait.
Paffenbarger Physical Activity Questionnaire
Participants will report their activity using the Paffenbarger Physical Activity Questionnaire. Time spent in each activity category will be recorded.
Participant device preference
The participant will rank order their preference for their standard of care device, Reaktiv and Phatbrace on a questionnaire.
Secondary Outcome Measures
Full Information
NCT ID
NCT03901053
First Posted
March 25, 2019
Last Updated
October 24, 2023
Sponsor
Jason Wilken
Collaborators
Minneapolis Veterans Affairs Medical Center, Walter Reed National Military Medical Center, Henry M. Jackson Foundation for the Advancement of Military Medicine, Center for Veterans Research and Education, University of Delaware, Johns Hopkins Bloomberg School of Public Health
1. Study Identification
Unique Protocol Identification Number
NCT03901053
Brief Title
Ankle Foot Orthosis Comparative Effect
Acronym
AFOCE
Official Title
Comparative Effect of Commercially Available Custom Dynamic Orthoses (CDOs)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jason Wilken
Collaborators
Minneapolis Veterans Affairs Medical Center, Walter Reed National Military Medical Center, Henry M. Jackson Foundation for the Advancement of Military Medicine, Center for Veterans Research and Education, University of Delaware, Johns Hopkins Bloomberg School of Public Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Injuries and Disorders
Keywords
Ankle Foot Orthoses, Carbon Fiber, Gait, Adult, Biomechanics, Materials Testing, Physical Performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
71 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AB
Arm Type
Experimental
Arm 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.
Arm Title
BA
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Reaktiv AFO
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PhatBrace AFO
Intervention Description
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.
Primary Outcome Measure Information:
Title
PROMIS Patient reported outcomes for physical function
Description
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
Title
PROMIS Patient reported outcomes for pain interference
Description
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
Title
PROMIS Patient reported outcomes for pain behavior
Description
The Patient Reported Outcome Information System (PROMIS) pain behavior Computer Adaptive Test (CAT) is a computerized assessment measuring pain behavior. 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
Title
PROMIS Patient reported outcomes for depression
Description
The Patient Reported Outcome Information System (PROMIS) depression Computer Adaptive Test (CAT) is a computerized assessment measuring depression. 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
Title
PROMIS Patient reported outcomes for satisfaction with participation in social activities
Description
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
Title
PROMIS Patient reported outcomes for satisfaction with participation in social roles
Description
The Patient Reported Outcome Information System (PROMIS) satisfaction with participation in social roles Computer Adaptive Test (CAT) is a computerized assessment measuring satisfaction with participation in social roles. 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
Title
Four-square step test (4SST- Timed)
Description
The 4SST is a standardized timed test of balance and agility.
Time Frame
3 months
Title
Self-selected walking velocity (SSWV - Timed)
Description
SSWV will be assessed using the timed 10 meter walk test.
Time Frame
3 months
Title
Single leg stance test with eyes open on foam (SLSEOF - Timed)
Description
SLSEOF test will be used to assess balance while standing on one leg on a closed-cell foam pad.
Time Frame
3 months
Title
Sit to stand 5 times (STS5 - Timed)
Description
STS5 is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to stand up and sit down 5 times as fast as possible.
Time Frame
3 months
Title
10 meter shuttle run (10M Shuttle - Timed)
Description
The 10 meter shuttle run is a well-established timed measure of speed.
Time Frame
3 months
Title
Timed Stair Ascent (TSA - Timed)
Description
The timed stair ascent test is a measure of mobility, agility, and lower limb muscle strength. Participants are instructed to ascend a flight of 12 steps as quickly and safely as possible while contacting every step.
Time Frame
3 months
Title
Activities-Specific Balance Confidence (ABC)
Description
The ABC provides a standardized evaluation of balance confidence across a range of common daily tasks.
Time Frame
3 months
Title
Satisfaction with device (OPUS - CSD)
Description
Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Lower scores indicate a better outcome.
Time Frame
3 months
Title
Satisfaction with services (OPUS - CSS)
Description
Satisfaction with services will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Services Score (10-50). Lower scores indicate a better outcome.
Time Frame
3 months
Title
Modified Socket Comfort Score (Comfort and Smoothness)
Description
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable, and from 0 = least smooth to 10 = most smooth.
Time Frame
3 months
Title
Numerical Pain Rating Scale
Description
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
Title
Ankle joint moment
Description
Peak ankle joint moment (Nm/kg) during gait.
Time Frame
3 months
Title
Ankle joint power
Description
Peak ankle joint moment (W/kg) during gait.
Time Frame
3 months
Title
Center of pressure velocity timing
Description
Timing of peak center of pressure velocity (percent stance) during gait.
Time Frame
3 months
Title
Center of pressure velocity magnitude
Description
Magnitude of peak center of pressure velocity (m/s) during gait.
Time Frame
3 months
Title
Paffenbarger Physical Activity Questionnaire
Description
Participants will report their activity using the Paffenbarger Physical Activity Questionnaire. Time spent in each activity category will be recorded.
Time Frame
3 months
Title
Participant device preference
Description
The participant will rank order their preference for their standard of care device, Reaktiv and Phatbrace on a questionnaire.
Time Frame
After 3 months of accomodation with the final device (Crossover study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason M. Wilken, PT, PhD
Phone
319-335-6857
Email
jason-wilken@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason M. Wilken, PT, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason M. Wilken, PT, PhD
Phone
319-335-6857
Email
jason-wilken@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Molly Pacha, MS, ATC, LAT
Phone
319-290-7596
Email
molly-pacha@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Natalie Glass, PhD
First Name & Middle Initial & Last Name & Degree
Molly Pacha, MS, ATC, LAT
First Name & Middle Initial & Last Name & Degree
Michael Willey, MD
First Name & Middle Initial & Last Name & Degree
Jeff Palmer, CPO, LPO
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Dearth, PhD
Facility Name
Minneapolis VA Health Care System
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Hansen, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Ankle Foot Orthosis Comparative Effect
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