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

NCT ID: NCT05456295

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-17

Study Completion Date

2025-09-29

Brief Summary

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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.

Detailed Description

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Traumatic lower limb injuries often result in poor functional outcomes with long-term negative effects. Carbon fiber custom dynamic orthoses (CDOs) can improve outcomes by reducing pain, supporting the limb, and transferring forces around the limb through the CDO. 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. Although CDOs are becoming more commonly prescribed following injury the evidence available to guide clinical practice remains limited. The important role of the proximal cuff has not been systematically 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. Two groups of individuals will participate: individuals with post-traumatic osteoarthritis in the ankle and healthy individuals. Testing will occur without an orthosis and while wearing orthoses with four proximal cuff designs representative of currently available devices: 1) a rigid patellar tendon bearing (PTB) clamshell cuff secured using a mechanical ratcheting system, 2) a PTB shell with a fixed pivot point secured with Velcro, 3) a rigid clamshell cuff secured with Velcro, and 4) a semi-rigid cuff with a flexible outer layer secured with Velcro.

Conditions

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Healthy Lower Limb Injury Post-Traumatic Osteoarthritis

Keywords

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Gait Analysis Ankle Foot Orthosis Carbon Fiber Biomechanics Adult Arthritis Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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NoCDO

Participants will be tested with no CDO

Group Type NO_INTERVENTION

No interventions assigned to this group

CUFF-A

The first study CDO will be designated CUFF-A

Group Type EXPERIMENTAL

Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type 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.

CUFF-B

The first study CDO will be designated CUFF-B

Group Type EXPERIMENTAL

Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type 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.

CUFF-C

The first study CDO will be designated CUFF-C

Group Type EXPERIMENTAL

Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type 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.

CUFF-D

The first study CDO will be designated CUFF-D

Group Type EXPERIMENTAL

Carbon Fiber Custom Dynamic Orthosis (CDO)

Intervention Type 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.

Interventions

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Carbon Fiber Custom Dynamic Orthosis (CDO)

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.

Intervention Type DEVICE

Other Intervention Names

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Ankle Foot Orthosis (AFO)

Eligibility Criteria

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Inclusion Criteria

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


1. Ages 18-65.
2. Without current complaint of lower extremity pain, spine pain, open wounds or active infection.
3. Ability to hop without pain.
4. Ability to perform a full squat without pain.
5. Ability to read and write in English and provide written informed consent.

Exclusion Criteria

1. Diagnosis with a moderate or severe brain injury.
2. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition…).
3. Ankle weakness as a result of spinal cord injury or nervous system pathology.
4. Nerve, muscle, bone, or other condition limiting function in the contralateral extremity.
5. Rheumatoid or inflammatory arthritis.
6. Necrosis of any bones in the foot or ankle.
7. Pain of 8/10 or greater during walking.
8. Surgery on study limb anticipated in the next 6 months.
9. Uncorrected visual or hearing impairments.
10. Require use of a stabilizing device (i.e. Ankle Foot Orthosis or Knee Orthosis…) to perform daily activities.
11. Pregnancy
12. Body mass index greater than 40.

HEALTHY ABLE-BODIED PARTICIPANTS:


1. Diagnosis with a moderate or severe brain injury.
2. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition).
3. Medical conditions or injuries that have limited participation in work or exercise in the last 6 months.
4. Medical conditions of injuries limiting function for greater than 6 weeks.
5. Uncorrected visual or hearing impairments.
6. Use of an assistive device.
7. Pregnancy
8. Body mass index greater than 35.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fabtech Systems

UNKNOWN

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Jason Wilken

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason M Wilken, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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202202450

Identifier Type: -

Identifier Source: org_study_id