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Orthosis
Carbon Fiber Orthosis for Lower Limb Injury (AFOCUFF Trial)
N/A
Recruiting
Led By Jason M Wilken, PT, PhD
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
AFOCUFF Trial Summary
This trial is testing different designs of a carbon fiber custom dynamic orthosis (CDO) to see how they affect patients' comfort, limb mechanics and loading, and the effective stiffness of the CDO.
Who is the study for?
This trial is for adults aged 18-50 with unilateral ankle PTOA who can walk 50 feet and hop without pain, do a full squat, and don't need walking aids. They must not have severe lower extremity issues, inflammatory arthritis, recent surgeries planned on the study limb or be pregnant. A BMI over 40 or serious brain injury also disqualifies.Check my eligibility
What is being tested?
The study tests how different cuff designs of Carbon Fiber Custom Dynamic Orthoses (CDOs) affect comfort, preference, leg mechanics and loading during walking. CDOs are braces that support the leg below the knee to aid in movement for those with leg injuries.See study design
What are the potential side effects?
While specific side effects aren't listed for this device trial, participants may experience discomfort or skin irritation where the orthosis contacts the leg. There could also be changes in gait that might lead to muscle soreness.
AFOCUFF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Numerical Pain Rating Scale
PROMIS Patient Reported Outcomes for Pain Interference
PROMIS Patient Reported Outcomes for Physical Function
+9 moreSecondary outcome measures
Ankle Range of Motion
Modified Socket Comfort Score (Comfort)
Modified Socket Comfort Score (Smoothness)
+2 moreOther outcome measures
Center of Pressure Velocity Magnitude
Center of Pressure Velocity Timing
Medial Gastrocnemius Muscle Activity
+4 moreAFOCUFF Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: CUFF-DExperimental Treatment1 Intervention
The first study CDO will be designated CUFF-D
Group II: CUFF-CExperimental Treatment1 Intervention
The first study CDO will be designated CUFF-C
Group III: CUFF-BExperimental Treatment1 Intervention
The first study CDO will be designated CUFF-B
Group IV: CUFF-AExperimental Treatment1 Intervention
The first study CDO will be designated CUFF-A
Group V: NoCDOActive Control1 Intervention
Participants will be tested with no CDO
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carbon Fiber Custom Dynamic Orthosis (CDO)
2021
N/A
~10
Find a Location
Who is running the clinical trial?
University of IowaLead Sponsor
446 Previous Clinical Trials
879,468 Total Patients Enrolled
Bio-Mechanical CompositesUNKNOWN
1 Previous Clinical Trials
27 Total Patients Enrolled
Jason M Wilken, PT, PhDPrincipal InvestigatorUniversity of Iowa
11 Previous Clinical Trials
314 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 50 years old.I have been diagnosed with a moderate or severe brain injury.I don't have leg, back pain, open wounds, or infections right now.I need a device like a brace for my ankle or knee to do everyday tasks.I have had health issues or injuries that stopped me from working or exercising in the past 6 months.I can do a full squat without feeling pain.I have a condition that limits the use of my opposite limb.I have post-traumatic osteoarthritis.I have been diagnosed with arthritis in one ankle.I have ankle weakness due to a spinal cord injury or nerve disease.I experience severe pain of 8 or more out of 10 when walking.I have vision or hearing problems that haven't been corrected.I have rheumatoid or inflammatory arthritis.I can hop without feeling pain.I have dead tissue in the bones of my foot or ankle.I am healthy and do not have any disabilities.I can walk without using a cane or crutch.I do not have any health conditions that would prevent me from undergoing functional tests.I can walk 50 feet at a slow to moderate pace.I am expected to have surgery on my limb within the next 6 months.I have a medical condition or injury that has limited my activities for more than 6 weeks.I use a device to help me walk or move.I can do a full squat without feeling pain.I can hop without feeling pain.I have been diagnosed with arthritis in one ankle.I can walk 50 feet at a slow to moderate pace.
Research Study Groups:
This trial has the following groups:- Group 1: CUFF-D
- Group 2: NoCDO
- Group 3: CUFF-A
- Group 4: CUFF-B
- Group 5: CUFF-C
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can those who are younger than 75 years old partake in the examination?
"This medical trial requires that participants are between the ages of 18 to 50, with 51 trials specifically designed for those under 18 and 377 catered towards an older population."
Answered by AI
What are the requirements for participation in this investigation?
"For this clinical trial, 34 individuals living with degenerative polyarthritis and aged 18 to 50 years old are sought after. Key criteria for participation include: ages between 18-50; the capacity to progress at a leisurely or normal speed over fifty feet without external support; literacy in English language as well as the ability to provide written consent; and an established diagnosis of unilateral ankle PTOA."
Answered by AI
Are applications still being accepted for this trial?
"According to clinicaltrials.gov, this particular trial has suspended its recruitment of patients since July 8th 2022. Although this study is no longer actively recruiting, there are 851 other trials that have active enrollment programs at present."
Answered by AI
What are the desired outcomes of this medical trial?
"This clinical trial will use the Modified Socket Comfort Score (Comfort and Smoothness) to evaluate its primary outcome over a baseline period. Secondary outcomes that are being assessed include Soleus Muscle Activity measured by Electromyography, PROMIS Patient Reported Outcomes for Physical Function evaluated using T-scores, as well as PROMIS Patient Reported Outcomes for Pain Interference also examined through T-score metrics."
Answered by AI
Who else is applying?
What state do they live in?
Iowa
What site did they apply to?
University of Iowa
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Email
Most responsive sites:
- University of Iowa: < 48 hours
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