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Ankle Foot Orthosis
Ankle Foot Orthoses for Foot Injuries (AFOCE Trial)
N/A
Waitlist Available
Led By Jason M. Wilken, PT, PhD
Research Sponsored by Jason Wilken
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages: 18-65
Limited pain free ankle motion (DF<10deg or PF<20deg)
Must not have
Require a knee stabilizing device (i.e. Knee-Ankle Foot Orthosis or Knee Orthosis) to perform daily activities
Ankle weakness as a result of spinal cord injury or central nervous system pathology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two types of custom-fit carbon fiber leg braces to help adults who had serious lower leg injuries and still have trouble moving. The braces are designed to give extra support and make it easier to walk. Researchers will compare how well each brace works by measuring things like balance, speed, and comfort.
Who is the study for?
This trial is for adults aged 18-65 who have had a severe lower leg injury below the knee over two years ago, can walk at least 50 feet without support, and are experiencing mechanical pain. They must not be pregnant, require a knee stabilizing device for daily activities, or have conditions that would interfere with testing like severe brain injuries or heart conditions.
What is being tested?
The study compares two custom-fit carbon fiber braces: Reaktiv AFO and PhatBrace AFO. It aims to determine which brace better improves function after serious lower leg injuries by assessing their form, fit, and function in participants' outcomes.
What are the potential side effects?
While specific side effects aren't listed for wearing these orthoses (braces), potential issues could include skin irritation from the brace material, discomfort during use, or an adjustment period to walking with the new device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I have limited movement in my ankle without pain.
Select...
I am considered for amputation due to severe ankle/foot problems.
Select...
I have weakness in my ankle when trying to point my toes down.
Select...
I can walk 50 feet without needing a cane or crutch.
Select...
I experience significant pain in my foot when putting weight on it.
Select...
I have had or am a candidate for ankle or hindfoot fusion surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need a device to help stabilize my knee for daily activities.
Select...
I have ankle weakness due to a spinal cord injury or brain condition.
Select...
I have visual or hearing issues that affect my walking or following instructions.
Select...
My pain is more than 8 out of 10 when I walk.
Select...
My BMI is over 45.
Select...
I do not have severe health issues that would stop me from undergoing tests.
Select...
I have a condition that limits the use of my opposite limb.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
10 meter shuttle run (10M Shuttle - Timed)
Activities-Specific Balance Confidence (ABC)
Ankle joint power
+11 moreSecondary study objectives
Ankle joint moment
PROMIS Patient reported outcomes for satisfaction with participation in social activities
Paffenbarger Physical Activity Questionnaire
Other study objectives
PROMIS Patient reported outcomes for depression
PROMIS Patient reported outcomes for pain behavior
PROMIS Patient reported outcomes for satisfaction with participation in social roles
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: BAExperimental Treatment2 Interventions
Participants in this arm will receive the PhatBrace AFO by Bio-Mechanical Composites Inc. first, then the Reaktiv AFO made by FabTech Systems LLC second.
Group II: ABExperimental Treatment2 Interventions
Participants in this arm will receive the Reaktiv AFO made by FabTech Systems LLC first, then the PhatBrace AFO by Bio-Mechanical Composites Inc. second.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Reaktiv AFO
2020
N/A
~60
PhatBrace AFO
2020
N/A
~60
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for foot injuries and disorders include custom fit carbon fiber braces, orthotic insoles, and therapeutic shoes. These treatments primarily work by providing structural support to the foot, enhancing stability, redistributing weight, and restricting joint motion.
Custom fit carbon fiber braces, in particular, improve function by reducing pain and correcting gait abnormalities. This is crucial for patients as it not only alleviates discomfort but also enhances mobility and overall quality of life, allowing for better participation in daily activities.
Custom shoe therapy. Current concepts, designs, and special considerations.Multi-segment foot models and their use in clinical populations.Effect of Full-Length Carbon Fiber Insoles on Lower Limb Kinetics in Patients With Midfoot Osteoarthritis: A Pilot Study.
Custom shoe therapy. Current concepts, designs, and special considerations.Multi-segment foot models and their use in clinical populations.Effect of Full-Length Carbon Fiber Insoles on Lower Limb Kinetics in Patients With Midfoot Osteoarthritis: A Pilot Study.
Find a Location
Who is running the clinical trial?
Jason WilkenLead Sponsor
1 Previous Clinical Trials
35 Total Patients Enrolled
Minneapolis Veterans Affairs Medical CenterFED
76 Previous Clinical Trials
16,284 Total Patients Enrolled
Walter Reed National Military Medical CenterFED
140 Previous Clinical Trials
33,139 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need a device to help stabilize my knee for daily activities.I am between 18 and 65 years old.I have limited movement in my ankle without pain.I am considered for amputation due to severe ankle/foot problems.I have ankle weakness due to a spinal cord injury or brain condition.I can walk at a slow to moderate pace.I have visual or hearing issues that affect my walking or following instructions.My pain is more than 8 out of 10 when I walk.I have weakness in my ankle when trying to point my toes down.My BMI is over 45.I am expecting surgery on my limb within the next 6 months.I can walk 50 feet without needing a cane or crutch.I experience significant pain in my foot when putting weight on it.I had a serious injury below my knee over two years ago that still affects my mobility.I do not have severe health issues that would stop me from undergoing tests.I have had or am a candidate for ankle or hindfoot fusion surgery.I have a condition that limits the use of my opposite limb.
Research Study Groups:
This trial has the following groups:- Group 1: AB
- Group 2: BA
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.
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