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Completed

NCT Number: NCT03901053

Ankle Foot Orthosis Comparative Effect

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.

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Key information

Conditions

Foot Injuries and Disorders Disease Foot Injuries Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa, Iowa City, Iowa, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  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. Activities-Specific Balance Confidence (ABC)

    Time frame: 3 months

    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.

  4. 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). Higher scores indicate a better outcome.

  5. Modified Socket Comfort Score (Comfort)

    Time frame: 3 months

    Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.

  6. Modified Socket Comfort Score (Comfort and Smoothness)

    Time frame: 3 months

    Smoothness scores range from 0 = least smooth to 10 = most smooth.

  7. 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.

  8. Participant Device Preference

    Time frame: After 3 months of accomodation with the final device (Crossover study)

    The participant will rank order their preference for the Reaktiv and Phatbrace on a questionnaire.

  9. Four-square Step Test (4SST- Timed)

    Time frame: 3 months

    The 4SST is a standardized timed test of balance and agility. Measured in seconds with lower scores indicating better balance and agility.

  10. Self-selected Walking Velocity (SSWV - Timed)

    Time frame: 3 months

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

  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. Measured in seconds.

  12. Ankle Joint Power

    Time frame: 3 months

    Peak ankle joint moment (W/kg) during gait.

  13. Center of Pressure Velocity Timing

    Time frame: 3 months

    Timing of peak center of pressure velocity (percent stance) during gait.

  14. Center of Pressure Velocity Magnitude

    Time frame: 3 months

    Magnitude of peak center of pressure velocity (m/s) during gait.

Secondary outcomes

  1. 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.

  2. Paffenbarger Physical Activity Questionnaire

    Time frame: Baseline

    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.

  3. Ankle Joint Moment

    Time frame: 3 months

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

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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). Higher scores indicate a better outcome.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Jason Wilken

Other

Collaborators

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

Registry information

Official study title

Comparative Effect of Commercially Available Custom Dynamic Orthoses (CDOs)

Acronym: AFOCE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2019
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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