Comparative Effect of Carbon Fiber Orthosis Cuff Design on Preference, Comfort, and Mechanics

NCT05456295 | Completed FDA Device

• 2 other identifiers: 202202450CDMRP-OP210037
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Carbon fiber custom dynamic orthoses (CDOs) consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that stores and returns energy during gait, and a carbon fiber foot plate that supports the foot and allows bending of the posterior strut. The proximal cuff is a primary interface between the patient and the CDO and may influence comfort, preference, limb mechanics and loading, and effective stiffness of the CDO. The important role of the proximal cuff has not been examined. The purpose of this study is to determine the effects of CDO proximal cuff design on patient reported outcomes, limb mechanics and loading, and CDO mechanical characteristics.

Conditions

Healthy; Lower Limb Injury; Post-Traumatic Osteoarthritis

Keywords

Gait Analysis; Ankle Foot Orthosis; Carbon Fiber; Biomechanics; Adult; Arthritis; Healthy

Outcome Measures

Primary Outcomes (12)

• Peak Plantar Force (total foot)

  Force data (N) collected from the total foot (100% of sensor), measured between the foot and orthosis during gait.

  Baseline

• Plantar Force Impulse (total foot)

  Plantar force impulse (Ns) across the total foot (100% of sensor) will be calculated using the integral of the force over the stance phase as participants walk in each study condition.

  Baseline

• Peak Plantar Force (forefoot)

  Force data (N) collected from the total foot (distal 40% of sensor), measured between the foot and orthosis during gait.

  Baseline

• Plantar Force Impulse (forefoot)

  Plantar force impulse (Ns) across the total foot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk in each study condition.

  Baseline

• Peak Plantar Force (midfoot)

  Force data (N) collected from the total foot (middle 30% of sensor), measured between the foot and orthosis during gait.

  Baseline

• Plantar Force Impulse (midfoot)

  Plantar force impulse (Ns) across the total foot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk in each study condition.

  Baseline

• Peak Plantar Force (hindfoot)

  Force data (N) collected from the total foot (proximal 30% of sensor), measured between the foot and orthosis during gait.

  Baseline

• Plantar Force Impulse (hindfoot)

  Plantar force impulse (Ns) across the total foot (proximal 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk in each study condition.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• Participant Device Preference

  The participant will rank order their preference for their standard of care device (if applicable), NoCDO, CUFF-A, CUFF-B, CUFF-C, CUFF-D on a questionnaire.

  Baseline

Secondary Outcomes (5)

• Ankle Range of Motion

  Baseline

• Peak Ankle Moment

  Baseline

• Peak Ankle Power

  Baseline

• Modified Socket Comfort Score (Comfort)

  Baseline

• Modified Socket Comfort Score (Smoothness)

  Baseline

Other Outcomes (7)

• Center of Pressure Velocity Timing

  Baseline

• Center of Pressure Velocity Magnitude

  Baseline

• Tibialis Anterior Muscle Activity

  Baseline

Study Arms (5)

NoCDO

NO INTERVENTION

Participants will be tested with no CDO

CUFF-A

EXPERIMENTAL

The first study CDO will be designated CUFF-A

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

CUFF-B

EXPERIMENTAL

The first study CDO will be designated CUFF-B

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

CUFF-C

EXPERIMENTAL

The first study CDO will be designated CUFF-C

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

CUFF-D

EXPERIMENTAL

The first study CDO will be designated CUFF-D

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

Interventions

Carbon Fiber Custom Dynamic Orthosis (CDO) DEVICE

The carbon fiber custom dynamic orthosis will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg below the knee. The design of the proximal cuff will differ between CUFF-A, CUFF-B, CUFF-C, CUFF-D.

Also known as: Ankle Foot Orthosis (AFO)

CUFF-A; CUFF-B; CUFF-C; CUFF-D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-65.
• Diagnosis of ankle PTOA.
• Ability to walk 50 feet at a slow to moderate pace.
• Ability to walk without a cane or crutch.
• Ability to read and write in English and provide written informed consent.

You may not qualify if:

• Diagnosis with a moderate or severe brain injury.
• Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition…).
• Ankle weakness as a result of spinal cord injury or nervous system pathology.
• Nerve, muscle, bone, or other condition limiting function in the contralateral extremity.
• Rheumatoid or inflammatory arthritis.
• Necrosis of any bones in the foot or ankle.
• Pain of 8/10 or greater during walking.
• Surgery on study limb anticipated in the next 6 months.
• Uncorrected visual or hearing impairments.
• Require use of a stabilizing device (i.e. Ankle Foot Orthosis or Knee Orthosis…) to perform daily activities.
• Pregnancy
• Body mass index greater than 40.
• HEALTHY ABLE-BODIED PARTICIPANTS:
• Ages 18-65.
• Without current complaint of lower extremity pain, spine pain, open wounds or active infection.

Sponsors & Collaborators

• University of Iowa: lead
• Fabtech Systems: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52241, United States

Location

MeSH Terms

Conditions

Leg Injuries; Arthritis

Condition Hierarchy (Ancestors)

Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Jason M Wilken, PT, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded, to the greatest extent possible, to the different CDO designs and will only be introduced to each device as CUFF-A, CUFF-B, CUFF-C, CUFF-D.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All participants will be cast and fit with CDOs with four different proximal cuff designs. CDOs will be labeled as CUFF-A, CUFF-B, CUFF-C, CUFF-D. Testing order of the proximal cuff designs will be randomized to prevent influence of study results.

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: July 13, 2022
• Study Start: May 17, 2023
• Primary Completion: September 29, 2025
• Study Completion: September 29, 2025
• Last Updated: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)