Ankle Foot Orthosis Comparative Effect

NCT03901053 | Completed Results FDA Device

• 2 other identifiers: 201901829CDMRP-OP170060
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

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.

Conditions

Foot Injuries and Disorders

Keywords

Ankle Foot Orthoses; Carbon Fiber; Gait; Adult; Biomechanics; Materials Testing; Physical Performance

Outcome Measures

Primary Outcomes (14)

• 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 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.

  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.

  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 the 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. Measured in seconds with lower scores indicating better balance and agility.

  3 months

• Self-selected Walking Velocity (SSWV - Timed)

  SSWV will be assessed using the timed 10 meter walk test. Measured in seconds.

  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.

  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 Outcomes (3)

• PROMIS Patient Reported Outcomes for Satisfaction With Participation in Social Activities

  3 months

• Paffenbarger Physical Activity Questionnaire

  Baseline

• Ankle Joint Moment

  3 months

Other Outcomes (6)

• PROMIS Patient Reported Outcomes for Pain Behavior

  3 months

• PROMIS Patient Reported Outcomes for Depression

  3 months

• PROMIS Patient Reported Outcomes for Satisfaction With Participation in Social Roles

  3 months

Study Arms (2)

AB

EXPERIMENTAL

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; Device: PhatBrace AFO

BA

EXPERIMENTAL

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; Device: PhatBrace AFO

Interventions

Reaktiv AFO DEVICE

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.

AB; BA

PhatBrace AFO DEVICE

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.

AB; BA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jason Wilken: lead
• Minneapolis Veterans Affairs Medical Center: collaborator
• Walter Reed National Military Medical Center: collaborator
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator
• Center for Veterans Research and Education: collaborator
• University of Delaware: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (3)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Foot Injuries; Disease

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jason M. Wilken, PT, PhD
• Organization: The University of Iowa

jason-wilken@uiowa.edu

319-335-6857

Study Officials

• Jason M. Wilken, PT, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: April 3, 2019
• Study Start: February 27, 2020
• Primary Completion: December 18, 2023
• Study Completion: December 18, 2023
• Last Updated: January 29, 2026
• Results First Posted: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)