Ankle Foot Orthosis Comparative Effect (AFOCE)

Comparative Effect of Commercially Available Custom Dynamic Orthoses (CDOs)

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.

Study Overview

• Status: Completed
• Conditions: Foot Injuries and Disorders
• Intervention / Treatment: Device: Reaktiv AFO; Device: PhatBrace AFO

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jason M. Wilken, PT, PhD; Phone Number: 319-335-6857; Email: jason-wilken@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis VA Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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
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
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
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
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
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)
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

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
Ankle joint moment	Peak ankle joint moment (Nm/kg) during gait.	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
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.	3 months
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.	3 months
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.	3 months
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.	3 months
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.	3 months

Collaborators and Investigators

• Sponsor: Jason Wilken
• Collaborators: Minneapolis Veterans Affairs Medical Center; Johns Hopkins Bloomberg School of Public Health; Walter Reed National Military Medical Center; University of Delaware; Henry M. Jackson Foundation for the Advancement of Military Medicine; Center for Veterans Research and Education
• Investigators: Principal Investigator: Jason M. Wilken, PT, PhD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Actual): December 18, 2023
• Study Completion (Actual): December 18, 2023

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Gait; Adult; Biomechanics; Physical Performance; Carbon Fiber; Ankle Foot Orthoses; Materials Testing
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Foot Injuries
• Other Study ID Numbers: 201901829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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