HealthyAFOCUFFNCT05456295
Comparative Effect of Carbon Fiber Orthosis Cuff Design on Preference, Comfort, and Mechanics
A study testing Carbon Fiber Custom Dynamic Orthosis (CDO) in people with Healthy and Lower Limb Injury, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Lower Limb Injury, Post-Traumatic Osteoarthritis
- What is being tested?
- Carbon Fiber Custom Dynamic Orthosis (CDO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2023to 29 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Ages 18-65.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy, Lower Limb Injury, Post-Traumatic Osteoarthritis
- Being tested
- Carbon Fiber Custom Dynamic Orthosis (CDO)
- Keywords
- Gait Analysis, Ankle Foot Orthosis, Carbon Fiber, Biomechanics, Adult, Arthritis, Healthy
- Medical subject headings
- Leg Injuries, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Fiber Custom Dynamic Orthosis (CDO)Device
Also called Ankle Foot Orthosis (AFO)
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.
| Study group | Role | What they receive |
|---|---|---|
| NoCDO | No intervention | Participants will be tested with no CDO |
| CUFF-A | Experimental | The first study CDO will be designated CUFF-A Receives: Device: Carbon Fiber Custom Dynamic Orthosis (CDO) |
| CUFF-B | Experimental | The first study CDO will be designated CUFF-B Receives: Device: Carbon Fiber Custom Dynamic Orthosis (CDO) |
| CUFF-C | Experimental | The first study CDO will be designated CUFF-C Receives: Device: Carbon Fiber Custom Dynamic Orthosis (CDO) |
| CUFF-D | Experimental | The first study CDO will be designated CUFF-D Receives: Device: Carbon Fiber Custom Dynamic Orthosis (CDO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plantar Force (total foot)
Force data (N) collected from the total foot (100% of sensor), measured between the foot and orthosis during gait.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (5)
Ankle Range of Motion
Peak ankle dorsiflexion (degrees) during gait.
Measured: Baseline
Peak Ankle Moment
Peak ankle moment (Nm/kg) during gait.
Measured: Baseline
Peak Ankle Power
Peak ankle power (W/kg) during gait.
Measured: Baseline
Modified Socket Comfort Score (Comfort)
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Measured: Baseline
Modified Socket Comfort Score (Smoothness)
Comfort scores range from 0 = least smooth to 10 = most smooth.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start17 May 2023
- Primary completion29 Sep 2025
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Fabtech Systems
- Responsible party
- Principal investigator, Jason Wilken, University of Iowa
- Investigators
- Jason M Wilken, PT, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456295
- Sponsor's protocol ID
- 202202450
- Other IDs
- CDMRP-OP210037
- Acronym
- AFOCUFF
- Status last verified
- Dec 2025
- First submitted
- 20 Jun 2022
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Carbon Fiber Orthosis Cuff Design on Preference, Comfort, and Mechanics
- ClinicalTrials.gov ID
- NCT05456295
- Acronym / sponsor ID
- AFOCUFF / 202202450
- Conditions
- Healthy, Lower Limb Injury, Post-Traumatic Osteoarthritis
- Keywords
- Gait Analysis, Ankle Foot Orthosis, Carbon Fiber, Biomechanics, Adult, Arthritis, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Fabtech Systems
- Study start
- 17 May 2023 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| NoCDO | No intervention | –Participants will be tested with no CDO |
| CUFF-A | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)The first study CDO will be designated CUFF-A |
| CUFF-B | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)The first study CDO will be designated CUFF-B |
| CUFF-C | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)The first study CDO will be designated CUFF-C |
| CUFF-D | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)The first study CDO will be designated CUFF-D |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon Fiber Custom Dynamic Orthosis (CDO)Also: Ankle Foot Orthosis (AFO)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. | Device | CUFF-A, CUFF-B, CUFF-C, CUFF-D |
Primary outcome
Peak Plantar Force (total foot)
Time frame: Baseline
Force data (N) collected from the total foot (100% of sensor), measured between the foot and orthosis during gait.
Plantar Force Impulse (total foot)
Time frame: Baseline
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.
Peak Plantar Force (forefoot)
Time frame: Baseline
Force data (N) collected from the total foot (distal 40% of sensor), measured between the foot and orthosis during gait.
Plantar Force Impulse (forefoot)
Time frame: Baseline
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.
Peak Plantar Force (midfoot)
Time frame: Baseline
Force data (N) collected from the total foot (middle 30% of sensor), measured between the foot and orthosis during gait.
Plantar Force Impulse (midfoot)
Time frame: Baseline
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.
Peak Plantar Force (hindfoot)
Time frame: Baseline
Force data (N) collected from the total foot (proximal 30% of sensor), measured between the foot and orthosis during gait.
Plantar Force Impulse (hindfoot)
Time frame: Baseline
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.
Numerical Pain Rating Scale
Time frame: Baseline
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
PROMIS Patient Reported Outcomes for Physical Function
Time frame: Baseline
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.
PROMIS Patient Reported Outcomes for Pain Interference
Time frame: Baseline
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.
Participant Device Preference
Time frame: Baseline
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.
5 secondary outcomes
Ankle Range of Motion
Time frame: Baseline
Peak Ankle Moment
Time frame: Baseline
Peak Ankle Power
Time frame: Baseline
Modified Socket Comfort Score (Comfort)
Time frame: Baseline
Modified Socket Comfort Score (Smoothness)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason M Wilken, PT, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon Fiber Custom Dynamic Orthosis (CDO) in people with Healthy and Lower Limb Injury, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plantar Force (total foot) (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.