Back to resultsComparative Effect of Carbon Fiber Orthosis Cuff Design on Preference, Comfort, and Mechanics (AFOCUFF)
Primary Purpose
Healthy, Lower Limb Injury, Post-Traumatic Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carbon Fiber Custom Dynamic Orthosis (CDO)
Sponsored by
About this trial
This is an interventional other trial for Healthy focused on measuring Gait Analysis, Ankle Foot Orthosis, Carbon Fiber, Biomechanics, Adult, Arthritis, Healthy
Eligibility Criteria
PARTICIPANTS WITH PTOA:
Inclusion Criteria:
- Ages 18-50.
- Diagnosis of unilateral 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.
Exclusion Criteria:
- 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:
Inclusion Criteria:
- Ages 18-50.
- Without current complaint of lower extremity pain, spine pain, open wounds or active infection.
- 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.
Exclusion Criteria:
- 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).
- Medical conditions or injuries that have limited participation in work or exercise in the last 6 months.
- Medical conditions of injuries limiting function for greater than 6 weeks.
- Uncorrected visual or hearing impairments.
- Use of an assistive device.
- Pregnancy
- Body mass index greater than 35.
Sites / Locations
- University of IowaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
No Intervention
Experimental
Experimental
Experimental
Experimental
Arm Label
NoCDO
CUFF-A
CUFF-B
CUFF-C
CUFF-D
Arm Description
Participants will be tested with no CDO
The first study CDO will be designated CUFF-A
The first study CDO will be designated CUFF-B
The first study CDO will be designated CUFF-C
The first study CDO will be designated CUFF-D
Outcomes
Primary Outcome Measures
Plantar Force (total foot)
Force data (N) collected from the total foot, measured between the foot and orthosis during gait.
Plantar Force (forefoot)
Force data (N) collected from the forefoot, measured between the foot and orthosis during gait.
Plantar Force (midfoot)
Force data (N) collected from the midfoot, measured between the foot and orthosis during gait.
Plantar Force (hindfoot)
Force data (N) collected from the hindfoot, measured between the foot and orthosis during gait.
Ankle Range of Motion
Peak ankle dorsiflexion (degrees) during gait.
Peak Ankle Moment
Peak ankle moment (Nm/kg) during gait.
Peak Ankle Power
Peak ankle power (W/kg) during gait.
Secondary Outcome Measures
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.
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.
Modified Socket Comfort Score (Comfort)
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Modified Socket Comfort Score (Smoothness)
Comfort scores range from 0 = least smooth to 10 = most smooth.
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.
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.
Full Information
NCT ID
NCT05456295
First Posted
June 20, 2022
Last Updated
August 4, 2023
Sponsor
University of Iowa
Collaborators
Bio-Mechanical Composites
1. Study Identification
Unique Protocol Identification Number
NCT05456295
Brief Title
Comparative Effect of Carbon Fiber Orthosis Cuff Design on Preference, Comfort, and Mechanics
Acronym
AFOCUFF
Official Title
Comparative Effect of Carbon Fiber Orthosis Cuff Design on Preference, Comfort, and Mechanics
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
Bio-Mechanical Composites
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Lower Limb Injury, Post-Traumatic Osteoarthritis
Keywords
Gait Analysis, Ankle Foot Orthosis, Carbon Fiber, Biomechanics, Adult, Arthritis, Healthy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NoCDO
Arm Type
No Intervention
Arm Description
Participants will be tested with no CDO
Arm Title
CUFF-A
Arm Type
Experimental
Arm Description
The first study CDO will be designated CUFF-A
Arm Title
CUFF-B
Arm Type
Experimental
Arm Description
The first study CDO will be designated CUFF-B
Arm Title
CUFF-C
Arm Type
Experimental
Arm Description
The first study CDO will be designated CUFF-C
Arm Title
CUFF-D
Arm Type
Experimental
Arm Description
The first study CDO will be designated CUFF-D
Intervention Type
Device
Intervention Name(s)
Carbon Fiber Custom Dynamic Orthosis (CDO)
Other Intervention Name(s)
Ankle Foot Orthosis (AFO)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plantar Force (total foot)
Description
Force data (N) collected from the total foot, measured between the foot and orthosis during gait.
Time Frame
Baseline
Title
Plantar Force (forefoot)
Description
Force data (N) collected from the forefoot, measured between the foot and orthosis during gait.
Time Frame
Baseline
Title
Plantar Force (midfoot)
Description
Force data (N) collected from the midfoot, measured between the foot and orthosis during gait.
Time Frame
Baseline
Title
Plantar Force (hindfoot)
Description
Force data (N) collected from the hindfoot, measured between the foot and orthosis during gait.
Time Frame
Baseline
Title
Ankle Range of Motion
Description
Peak ankle dorsiflexion (degrees) during gait.
Time Frame
Baseline
Title
Peak Ankle Moment
Description
Peak ankle moment (Nm/kg) during gait.
Time Frame
Baseline
Title
Peak Ankle Power
Description
Peak ankle power (W/kg) during gait.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
PROMIS Patient Reported Outcomes for Pain Interference
Description
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.
Time Frame
Baseline
Title
PROMIS Patient Reported Outcomes for Physical Function
Description
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.
Time Frame
Baseline
Title
Modified Socket Comfort Score (Comfort)
Description
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Time Frame
Baseline
Title
Modified Socket Comfort Score (Smoothness)
Description
Comfort scores range from 0 = least smooth to 10 = most smooth.
Time Frame
Baseline
Title
Numerical Pain Rating Scale
Description
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Time Frame
Baseline
Title
Participant Device Preference
Description
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.
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
Center of Pressure Velocity Timing
Description
Timing of peak center of pressure velocity (percent stance) during gait.
Time Frame
Baseline
Title
Center of Pressure Velocity Magnitude
Description
Magnitude of peak center of pressure velocity (m/s) during gait.
Time Frame
Baseline
Title
Semi-Structured Interview
Description
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.
Time Frame
Baseline
Title
Tibialis Anterior Muscle Activity
Description
Electromyography (EMG, % Maximum) of the tibialis anterior during gait.
Time Frame
Baseline
Title
Peroneus Longus Muscle Activity
Description
Electromyography (EMG, % Maximum) of the peroneus longus during gait.
Time Frame
Baseline
Title
Soleus Muscle Activity
Description
Electromyography (EMG, % Maximum) of the soleus during gait.
Time Frame
Baseline
Title
Medial Gastrocnemius Muscle Activity
Description
Electromyography (EMG, % Maximum) of the medial gastrocnemius during gait.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
PARTICIPANTS WITH PTOA:
Inclusion Criteria:
Ages 18-50.
Diagnosis of unilateral 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.
Exclusion Criteria:
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:
Inclusion Criteria:
Ages 18-50.
Without current complaint of lower extremity pain, spine pain, open wounds or active infection.
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.
Exclusion Criteria:
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).
Medical conditions or injuries that have limited participation in work or exercise in the last 6 months.
Medical conditions of injuries limiting function for greater than 6 weeks.
Uncorrected visual or hearing impairments.
Use of an assistive device.
Pregnancy
Body mass index greater than 35.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason M Wilken, PT, PhD
Phone
3193356857
Email
jason-wilken@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsten M Anderson, BSE
Phone
3193530431
Email
kirsten-m-anderson@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason M Wilken, PT, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52241
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason M Wilken, PT, PhD
Phone
319-335-6857
Email
jason-wilken@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Kirsten M Anderson, BSE
Phone
3193530431
Email
kirsten-m-anderson@uiowa.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Effect of Carbon Fiber Orthosis Cuff Design on Preference, Comfort, and Mechanics
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