From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices (AFOSVA)

This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury.

Study Overview

• Status: Not yet recruiting
• Conditions: Foot Injury
• Intervention / Treatment: Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO); Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO)

Detailed Description

This study is designed to evaluate how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influence outcomes following traumatic lower extremity injury. In this study, adult participants who still experiencing deficits including weakness and/or immobility more than two years post traumatic lower extremity injury will be randomized and fit with either modular or monolithic CDO.

Participants will then be evaluated without a CDO and with the CDO in three configurations in a randomized order: a proposed optimal benchmark configuration, a variation with the device in more dorsiflexion, and a variation with the device in greater plantarflexion. Multiple well-established tests will be used to compare outcomes between the different configurations.

• Study Type: Interventional
• Enrollment (Estimated): 35
• 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 Contact Backup: Name: Molly S Pacha, MS, ATC, LAT; Phone Number: 319-290-7596; Email: molly-pacha@uiowa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Between the ages of 18 and 65
• 2 or more years from a traumatic injury below the knee
• Ability to be fit with an orthosis

• Any of the following:

  • Weakness of ankle plantarflexors (<4/5 on manual muscle test)
  • Limited pain-free ankle motion (dorsiflexion (DF) <10° or plantarflexion (PF) <20°)
  • Mechanical pain with loading to hindfoot/midfoot (>4/10 Numerical pain rating scale)
  • Fusion or candidate for fusion of the ankle or hindfoot
  • Candidate for amputation secondary to ankle/foot injury and impairment

Exclusion Criteria:

• Pain greater than 8/10 at rest
• Ankle weakness or spasticity as a result of spinal cord injury or central nervous system pathology
• Use of an orthosis including the knee
• Non-ambulatory
• Surgery on study limb anticipated in next 4 months
• Medical or psychological conditions that would influence functional testing (e.g., severe traumatic brain injury, stroke, heart disease, vestibular disorder)
• Neurologic, musculoskeletal, or other conditions limiting function of the contralateral extremity
• Uncorrected visual or hearing impairments
• Pregnancy
• Non-English speaking
• BMI > 40

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NoCDO, A, B, C; Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration B, and finally CDO configuration C.	Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO); The CDO will use a modular design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.; Other Names: Reaktiv (Fabtech Systems LLC, Everett WA); Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO); The CDO will use a mono design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.; Other Names: Posterior Spring (Bio-Mechanical Composites, Inc., Des Moines, IA)
Experimental: NoCDO, A, C, B; Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration C, and finally CDO configuration B.	Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO); The CDO will use a modular design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.; Other Names: Reaktiv (Fabtech Systems LLC, Everett WA); Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO); The CDO will use a mono design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.; Other Names: Posterior Spring (Bio-Mechanical Composites, Inc., Des Moines, IA)
Experimental: NoCDO, B, A, C; Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration B, CDO configuration A, and finally CDO configuration C.	Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO); The CDO will use a modular design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.; Other Names: Reaktiv (Fabtech Systems LLC, Everett WA); Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO); The CDO will use a mono design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.; Other Names: Posterior Spring (Bio-Mechanical Composites, Inc., Des Moines, IA)
Experimental: NoCDO, B, C, A; Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration B, CDO configuration C, and finally CDO configuration A.	Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO); The CDO will use a modular design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.; Other Names: Reaktiv (Fabtech Systems LLC, Everett WA); Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO); The CDO will use a mono design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.; Other Names: Posterior Spring (Bio-Mechanical Composites, Inc., Des Moines, IA)
Experimental: NoCDO, C, A, B; Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration C, CDO configuration A, and finally CDO configuration B.	Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO); The CDO will use a modular design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.; Other Names: Reaktiv (Fabtech Systems LLC, Everett WA); Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO); The CDO will use a mono design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.; Other Names: Posterior Spring (Bio-Mechanical Composites, Inc., Des Moines, IA)
Experimental: NoCDO, C, B, A; Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration C, CDO configuration B, and finally CDO configuration A.	Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO); The CDO will use a modular design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.; Other Names: Reaktiv (Fabtech Systems LLC, Everett WA); Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO); The CDO will use a mono design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.; Other Names: Posterior Spring (Bio-Mechanical Composites, Inc., Des Moines, IA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS 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 greater physical function than the population average. Larger scores are better.	Baseline
PROMIS 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 greater pain interference than the population average. Lower scores are better.	Baseline
OPUS Satisfaction with Device and Services	Satisfaction with device and services will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device and Services Score (11-55). Lower scores indicate a better outcome and more satisfaction with the CDO and accompanying services.	Baseline
Modified Socket Comfort Score - Comfort	Participants were asked to rate the comfort of each CDO configuration on a scale from 0-10 with 0 = most uncomfortable to 10 = most comfortable. Higher scores indicate more comfortable conditions, and are considered better.	Baseline
Modified Socket Comfort Score - Smoothness	Participants were asked to rate the smoothness of each CDO configuration on a scale from 0-10 with 0 = most smooth to 10 = least smooth. Lower scores indicate smoother conditions, and are considered better.	Baseline
Numerical Pain Rating Scale	Pain will be assessed using a standard 11-point numerical pain rating scale (NPRS), in which 0 = no pain and 10 = worst pain imaginable. Lower scores are considered better.	Baseline
Preference - Ranked	The participant will be asked to rank order the conditions they have completed testing for at each visit: at the 3rd visit they will rank order their preference for using no orthosis or using the CDO in the first configuration, at the 4th visit they will rank order their preference for using no orthosis, using the CDO in the first configuration, and using the CDO in the second configuration, at the 5th visit they will rank order their preference for using no orthosis, using the CDO in the first configuration, using the CDO in the second configuration, and using the CDO in the third configuration.	Baseline
Preference - CDO Configuration	For each CDO configuration, participants will be asked to rank their preference on a scale from 0 (least preferred) to 10 (most preferred) for a number of questions concerning CDO use. Higher scores indicate higher preferences and are considered better.	Baseline
Four Square Step Test (seconds)	The 4SST (seconds) is a standardized timed test of balance and agility. Participants start in the lower left quadrant of a Maltese cross setting on the floor and are timed as they move counterclockwise (forward, right, backward, left) and then clockwise (right, forward, left, backward) around the cross. Participants are instructed to move as quickly as they safely can. Lower times indicate faster completion of the test and are considered better results.	Baseline
Sit to Stand 5 Times (seconds)	STS5 (seconds) 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. Lower scores indicate a faster time to complete the test and are considered better results.	Baseline
Center of Pressure Velocity Magnitude (m/s)	The center of pressure (CoP) is the centroid of the forces acting on the foot during gait. The magnitude of the peak center of pressure velocity (m/s) is the fastest the CoP moves during gait.	Baseline
Center of Pressure Velocity Timing (%stance)	The center of pressure (CoP) is the centroid of the forces acting on the foot during gait. The timing of the peak center of pressure velocity, is the percent of the stance phase (%stance) where the CoP is moving fastest during gait.	Baseline
Ankle Zero Moment Crossing (%stance)	The ankle zero moment crossing is the point during the stance phase of gait (%stance) where the ankle moment transitions from a dorsiflexion to a plantarflexion moment.	Baseline
Peak Ankle Dorsiflexion (degree)	Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint dorsiflexion angle (degree) that occurs late in the stance phase of gait.	Baseline
Peak Ankle Plantarflexion Moment (Nm/kg)	Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint plantarflexion moment normalized to participant body weight (Nm/kg) that occurs late in the stance phase of gait.	Baseline
Peak Ankle Push-Off Power (W/kg)	Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint power normalized to body weight (W/kg) occurs late in the stance phase of gait.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS 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 greater participation in social activities than the population average, larger scores are considered better.	Baseline
PROMIS Satisfaction with Participation in Discretionary 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 greater participation in discretionary social activities than the population average, larger scores are considered better.	Baseline
PROMIS 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 greater levels of depression than the population average, lower scores are considered better.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 Meter Shuttle Run (seconds)	The 10 meter shuttle run is a well-established timed measure of speed (seconds). There are two lines 10 meters about from each other, the participant starts at one line and two blocks are sitting at the second line. Participants are instructed to retrieve both blocks and move them behind the starting line as quickly as they safely can. Smaller scores indicate faster times to complete the test and are considered better.	Baseline
Self Selected Walking Velocity (m/s)	SSWV will be assessed using the timed 10 meter walk test where participants are asked to walk 10 meters at a comfortable self-selected pace (m/s). Participants are timed as they cross the middle 6 meters of the distance (the timer is started when they cross a mark 2 meters from the start line and is stopped once they cross a mark 8 meters from the start line). Smaller scores indicate a shorter time, therefore a faster self selected walking velocity, and are considered better.	Baseline
Ankle Range of Motion (degrees)	Participants completed a biomechanical gait analysis session. Sagittal plane ankle range of motion (degrees) was measured throughout the gait cycle. Smaller range of motion is expected with each CDO.	Baseline

Collaborators and Investigators

• Sponsor: Jason Wilken
• Collaborators: Johns Hopkins University; Mayo Clinic; Minneapolis Veterans Affairs Medical Center; Vanderbilt University Medical Center; Navy Medical Center San Diego
• Investigators: Principal Investigator: Jason M Wilken, PT, PhD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 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; Biomechanics; Physical Performance; Carbon Fiber; Ankle Foot Orthosis
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Foot Injuries; Anti-Infective Agents, Local; Anti-Infective Agents; Carbon Fiber
• Other Study ID Numbers: 202007224

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