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Ankle Foot Orthosis Comparative Effect (AFOCE)

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ClinicalTrials.gov Identifier: NCT03901053
Recruitment Status : Not yet recruiting
First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
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
Information provided by (Responsible Party):
Jason Wilken, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Foot Injuries and Disorders Device: Reaktiv AFO Device: PhatBrace AFO Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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 10 to achieve equal randomization between groups over time.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Effect of Commercially Available Custom Dynamic Orthoses (CDOs)
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AB
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
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.

Device: PhatBrace AFO
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.

Experimental: BA
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
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.

Device: PhatBrace AFO
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 Measures :
  1. PROMIS Patient reported outcomes for physical function [ Time Frame: 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.

  2. PROMIS Patient reported outcomes for pain interference [ Time Frame: 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.

  3. PROMIS Patient reported outcomes for pain behavior [ Time Frame: 3 months ]
    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.

  4. PROMIS Patient reported outcomes for depression [ Time Frame: 3 months ]
    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.

  5. PROMIS Patient reported outcomes for satisfaction with participation in social activities [ Time Frame: 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.

  6. PROMIS Patient reported outcomes for satisfaction with participation in social roles [ Time Frame: 3 months ]
    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.

  7. Four-square step test (4SST- Timed) [ Time Frame: 3 months ]
    The 4SST is a standardized timed test of balance and agility.

  8. Self-selected walking velocity (SSWV - Timed) [ Time Frame: 3 months ]
    SSWV will be assessed using the timed 10 meter walk test.

  9. Single leg stance test with eyes open on foam (SLSEOF - Timed) [ Time Frame: 3 months ]
    SLSEOF test will be used to assess balance while standing on one leg on a closed-cell foam pad.

  10. Sit to stand 5 times (STS5 - Timed) [ Time Frame: 3 months ]
    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.

  11. 10 meter shuttle run (10M Shuttle - Timed) [ Time Frame: 3 months ]
    The 10 meter shuttle run is a well-established timed measure of speed.

  12. Timed Stair Ascent (TSA - Timed) [ Time Frame: 3 months ]
    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.

  13. Activities-Specific Balance Confidence (ABC) [ Time Frame: 3 months ]
    The ABC provides a standardized evaluation of balance confidence across a range of common daily tasks.

  14. Satisfaction with device (OPUS - CSD) [ Time Frame: 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.

  15. Satisfaction with services (OPUS - CSS) [ Time Frame: 3 months ]
    Satisfaction with services will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Services Score (10-50). Lower scores indicate a better outcome.

  16. Modified Socket Comfort Score (Comfort and Smoothness) [ Time Frame: 3 months ]
    Comfort scores range from 0 = most uncomfortable to 10 = most comfortable, and from 0 = least smooth to 10 = most smooth.

  17. Numerical Pain Rating Scale [ Time Frame: 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.

  18. Ankle joint moment [ Time Frame: 3 months ]
    Peak ankle joint moment (Nm/kg) during gait.

  19. Ankle joint power [ Time Frame: 3 months ]
    Peak ankle joint moment (W/kg) during gait.

  20. Center of pressure velocity timing [ Time Frame: 3 months ]
    Timing of peak center of pressure velocity (percent stance) during gait.

  21. Center of pressure velocity magnitude [ Time Frame: 3 months ]
    Magnitude of peak center of pressure velocity (m/s) during gait.

  22. Paffenbarger Physical Activity Questionnaire [ Time Frame: 3 months ]
    Participants will report their activity using the Paffenbarger Physical Activity Questionnaire. Time spent in each activity category will be recorded.

  23. Participant device preference [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages: 18-50
  • 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 35
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901053


Contacts
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Contact: Jason M. Wilken, PT, PhD 319-335-6857 jason-wilken@uiowa.edu

Locations
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United States, Iowa
University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Jason M. Wilken, PT, PhD    319-335-6857    jason-wilken@uiowa.edu   
Contact: Molly Pacha, MS, ATC, LAT    319-290-7596    molly-pacha@uiowa.edu   
Sub-Investigator: Natalie Glass, PhD         
Sub-Investigator: Molly Pacha, MS, ATC, LAT         
Sub-Investigator: Michael Willey, MD         
Sub-Investigator: Jeff Palmer, CPO, LPO         
United States, Maryland
Walter Reed National Military Medical Center Not yet recruiting
Bethesda, Maryland, United States, 20889
Contact: Christopher Dearth, PhD         
United States, Minnesota
Minneapolis VA Health Care System Not yet recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Andrew Hansen, PhD         
Sponsors and Collaborators
Jason Wilken
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
Investigators
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Principal Investigator: Jason M. Wilken, PT, PhD University of Iowa

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Responsible Party: Jason Wilken, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03901053     History of Changes
Other Study ID Numbers: IRB# 201901829
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jason Wilken, University of Iowa:
Ankle Foot Orthoses
Carbon Fiber
Gait
Adult
Biomechanics
Materials Testing
Physical Performance
Additional relevant MeSH terms:
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Foot Injuries
Leg Injuries
Wounds and Injuries
Carbon Fiber
Anti-Infective Agents, Local
Anti-Infective Agents