Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress (PRMRP-FPA2)

The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. Research suggests that ankle arthritis develops after ankle fracture, in part, due to elevated forces on the cartilage. It is expected that carbon fiber braces can be designed to reduce forces in the ankle joint and thereby reduce the risk of developing arthritis following traumatic injury. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The proposed study will provide evidence that can be used by clinicians and researchers to design braces that most effectively reduce forces on ankle cartilage.

Study Overview

• Status: Completed
• Conditions: Post-traumatic Osteoarthritis; Ankle Fractures; Osteoarthritis Ankle
• Intervention / Treatment: Device: Custom Carbon Fiber Dynamic Orthosis (CDO)

Detailed Description

The primary purpose of this line of research is to investigate the effects of carbon fiber custom dynamic orthosis (CDO) design on the forces and contact stress at the ankle, with the goal of reducing the development of post traumatic osteoarthritis (PTOA) in the ankle. Research suggests that ankle arthritis develops, in part, due to increased contact stresses within the ankle joint following fracture. It is expected that reducing articular contact stress at the ankle has the potential to delay or prevent the development of PTOA. CDOs have been shown to significantly improve function following extremity injury, and show promise for offloading the injured limb after severe lower extremity injuries. Therefore, the proposed effort is designed to evaluate how different CDO design factors influence offloading and therefore the reduction of forces and articular contact stress at the ankle.

Adult participants will be evaluated while wearing carbon fiber braces of varied geometry. The primary dependent measure is ankle joint contact stress. Following consent and enrollment computerized tomography (CT) images will be used to determine the geometry of the joint articular surfaces. Ankle contact stress will be calculated using discrete element analysis and biomechanical data collected in subsequent data collection.

Participants will be cast and fit for three CDOs with varied geometry. Participants will be blinded to the design variation of each device and will only know them as CDO-A, CDO-B, or CDO-C. Testing will be completed under 4 conditions: No-CDO, CDO-A, CDO-B, CDO-C, with each bracing condition (A/B/C) representing a CDO design variant. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that changes to device design do not negatively affect physical function. Questionnaires will be used to evaluate participants' current and desired activity level, pain with and without CDO use, satisfaction with the devices, perception of comfort and smoothness between devices, and preference between CDOs. Semi-structured interviews will be completed to fully capture the participant's perspective. Lower limb forces and motion will be assessed using a computerized motion capture system and force plates in the floor. Forces between the foot and CDO will be measured using force sensing insoles, and muscle activity data will be collected using surface electromyography. Devices will be mechanically tested, and participant demographic and anthropometric data will be recorded.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

TIBIAL PILON FRACTURE PARTICIPANTS:

Inclusion Criteria:

• Ages: 18-65
• Sustained unilateral fracture of the tibial pilon within the preceding 5 years
• The fracture has completely healed
• Ability to walk 50 feet without use of an assistive device (cane, crutch, etc.)
• Ability to walk at a slow to moderate pace
• Shoe size between women's 8 and 13.5 or men's 6.5 and 13
• Ability to read and write in English and provide written informed consent
• Individuals with elevated contact stress according to model generated using PedCAT standing CT images (will be answered after completing visit one)

Exclusion Criteria:

• Pain > 6/10 while walking
• Increase in pain during testing of 3/10 or greater
• Neurologic, musculoskeletal (including bilateral fractures) or other condition limiting function of the contralateral extremity
• Medical or psychological condition that would preclude functional testing (ex. moderate or severe brain injury, stroke, heart disease)
• Wounds to the calf that would prevent CDO fitting
• Fractures secondary to neuropathy or severe osteopenia
• Classification as non-ambulatory
• Previous fractures near the tibial pilon on the involved limb
• Surgery on involved limb anticipated in the next 6 months
• Requirement of a knee stabilizing device (i.e. KAFO, KO…) to perform daily activities
• Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
• BMI greater than 40
• Pregnancy- Per participant self-report. Due to 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.

HEALTHY ABLE-BODIED PARTICIPANTS:

Patient Inclusion Criteria

• Between the ages of 18 and 65
• Shoe size between women's 8 and 13.5 or men's 6.5 and 13
• Healthy individuals without a current complaint of lower extremity pain, spine pain, or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months
• Full active range of motion of the bilateral lower extremities and spine
• Ability to hop without pain
• Ability to perform a full squat without pain
• Ability to read and write in English and provide written informed consent

Patient Exclusion Criteria

• Diagnosed moderate or severe brain injury
• Prior lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
• Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
• Visual or hearing impairment that would interfere with instructions given during testing
• Require an assistive device
• Wounds to the foot or calf that would prevent CDO use
• BMI greater than 40
• Pregnancy - Per participant self-report. Due to 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: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Device; Participants will be evaluated without a CDO.
Experimental: CDO-A; The first design variant will be designated CDO-A	Device: Custom Carbon Fiber Dynamic Orthosis (CDO); The custom carbon fiber dynamic orthoses will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.; Other Names: Ankle Foot Orthosis
Experimental: CDO-B; The second design variant will be designated CDO-B	Device: Custom Carbon Fiber Dynamic Orthosis (CDO); The custom carbon fiber dynamic orthoses will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.; Other Names: Ankle Foot Orthosis
Experimental: CDO-C; The third design variant will be designated CDO-C	Device: Custom Carbon Fiber Dynamic Orthosis (CDO); The custom carbon fiber dynamic orthoses will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.; Other Names: Ankle Foot Orthosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint Contact Stress Time Exposure (Model Estimated)	Joint contact stress time exposure (MPA-s/gait cycle) was estimated using a participant specific musculoskeletal model. Peak joint contact stress time exposure (MPA-s/gait cycle) acting on the tibia during the gait cycle were reported. Lower peak contact stress time exposure is considered a better outcome.	Baseline
Peak Plantar Force (Total Foot)	Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (100% of sensor) and normalized to participant body weight as they walk.	Baseline
Peak Plantar Force (Hindfoot)	Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (proximal 30% of sensor) as participants walk without a CDO and with each CDO.	Baseline
Peak Plantar Force (Midfoot)	Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (middle 30% of sensor) as participants walk without a CDO and with each CDO.	Baseline
Peak Plantar Force (Forefoot)	Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (distal 40% of sensor) as participants walk without a CDO and with each CDO.	Baseline
Plantar Force Impulse (Total Foot)	Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (100% of sensor) will be calculated using the integral of the force over the stance phase and normalized to participant body weight as they walk.	Baseline
Plantar Force Impulse (Hindfoot)	Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (proximal 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.	Baseline
Plantar Force Impulse (Midfoot)	Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.	Baseline
Plantar Force Impulse (Forefoot)	Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.	Baseline
Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC)	The participant will rank order their preference for their standard of care device (if applicable), No Device, CDO-A, CDO-B, CDO-C on a questionnaire.	Baseline
Participant Device Preference (First Preferred Condition)	Participants were asked to rank order their preference for NoCDO, CDO-A, CDO-B, CDO-C on a questionnaire.	Baseline
Participant Device Preference (Second Preferred Condition)	Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).	Baseline
Participant Device Preference (Third Preferred Condition)	Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).	Baseline
Participant Device Preference (Fourth Preferred Condition)	Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).	Baseline
Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS)	Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Lower values are better as they indicate less pain.	Baseline
Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS)	Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Lower values are better as they indicate less pain	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Orthotics Prosthetics Users' Survey (OPUS)	Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Lower scores indicate a better outcome.	Baseline
Ankle Range of Motion	Peak ankle dorsiflexion (degrees) during gait.	Baseline
Peak Ankle Power	Peak ankle push-off power (W/kg) during gait.	Baseline
Peak Ankle Moment	Peak ankle plantarflexion moment (Nm/kg) during gait.	Baseline
Peak Soleus Muscle Force (Model Estimated)	Peak soleus muscle force (N) during gait was estimated using a participant specific musculoskeletal model.	Baseline
Peak Gastrocnemius Muscle Force (Model Estimated)	Peak gastrocnemius muscle force (N) during gait was estimated using a participant specific musculoskeletal model.	Baseline
Four Square Step Test (4SST)	The 4SST (s) is a standardized timed test of balance and agility. One inch pipe is placed on the floor in the shape of a Maltese cross and participants are instructed to begin in the back left quadrant then to move 1) forward, 2) sideways right, 3) backward, then 4) sideways left, then to move in the reverse direction back to the original square.	Baseline
Sit to Stand 5 Times (STS5)	STS5 (s) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to start the test sitting with their arms folded across their chest and with their back against a standard chair. Patients are then instructed to stand up and sit down 5 times as fast as possible, avoiding touching their back to the chair during each repetition. The time to complete all five continuous repetitions is reported.	Baseline
Modified Socket Comfort Score (Comfort)	Comfort scores range from 0 = most uncomfortable to 10 = most comfortable. Higher scores are better as they indicate a more comfortable device.	Baseline
Modified Socket Comfort Score (Smoothness)	Comfort scores range from 0 = least smooth to 10 = most smooth. Higher scores are better as they indicate a smoother rollover with the device.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soleus Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the soleus during gait.	Baseline
Tibialis Anterior Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of theTibialis Anterior during gait.	Baseline
Medial Gastrocnemius Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the Medial Gastrocnemius during gait.	Baseline
Rectus Femoris Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the Rectus Femoris during gait.	Baseline
Vastus Medialis Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the Vastus Medialis during gait.	Baseline
Semi-Structured Interview	Semi-structured interviews will also be used to fully capture the patients' perspectives, experience, and opinions associated with the device options they experienced as part of the study.	Baseline
Center of Pressure Velocity Timing	Timing of peak center of pressure velocity (percent stance) during gait.	Baseline
Center of Pressure Velocity Magnitude	Magnitude of peak center of pressure velocity (m/s) during gait.	Baseline

Collaborators and Investigators

• Sponsor: University of Iowa
• Collaborators: University of Delaware; Bio-Mechanical Composites; Fabtech Systems
• Investigators: Principal Investigator: Jason M Wilken, PT, PhD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2020
• Primary Completion (Actual): October 5, 2023
• Study Completion (Actual): October 5, 2023

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Arthritis; Adult; Biomechanics; Gait Analysis; Ankle; Carbon Fiber; Ankle Foot Orthosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Leg Injuries; Fractures, Bone; Ankle Injuries; Arthritis; Ankle Fractures; Anti-Infective Agents; Anti-Infective Agents, Local; Carbon Fiber
• Other Study ID Numbers: 202002769; CDMRP-PR172087 (Other Grant/Funding Number: Department of Defense)

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