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Orthotic Device
Auto Adjusting Dynamic AFO for Foot and Ankle Injuries
N/A
Recruiting
Led By Joan E Sanders, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Use prescribed offloading AFO at least 20 hours per week
prescribed an offloading Ankle-Foot Orthosis (AFO) for walking/running
Timeline
Screening 3 weeks
Treatment Varies
Follow Up calculated across all days of data collection (up to 4 weeks).
Awards & highlights
Study Summary
This trial is testing a new, adjustable ankle-foot brace that may help people with lower-limb reconstruction regain mobility while reducing long-term damage to joints.
Who is the study for?
This trial is for individuals who use an offloading Ankle-Foot Orthosis (AFO) at least 20 hours a week, have had major lower-limb surgery and are at least six months post-operation. Participants must be able to run for one minute continuously and have been prescribed an AFO with a strut length of at least 200 mm.Check my eligibility
What is being tested?
The study is testing a new type of dynamic brace called Variable Stiffness AFO, designed to adjust its stiffness based on the user's activity level. The goal is to improve mobility while protecting the injury site and nearby joints from long-term damage.See study design
What are the potential side effects?
Since this trial involves a physical device rather than medication, side effects may include discomfort or skin irritation where the brace contacts the body, potential strain on adjacent joints due to altered walking patterns, or issues related to improper fit.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I use my prescribed ankle-foot orthosis for over 20 hours a week.
Select...
I use a special brace for my ankle and foot to help me walk or run.
Select...
I had surgery for a major leg injury over 6 months ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ calculated across all days of data collection (up to 4 weeks).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~calculated across all days of data collection (up to 4 weeks).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Extended Figure-of-8 Test
Longest Running Bout Duration
Orthotic Evaluation Questionnaire (OEQ)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Aim 3Experimental Treatment1 Intervention
Participants will be asked to take the Dynamic AFO home and wear the device for up to 4 weeks. The device will be set in either an adjustment-capable mode, or a "locked" mode that functions similar to their own orthotic--the order in which they are tested will be randomized.
Group II: Aim 2Experimental Treatment1 Intervention
Participants will carry out a protocol comprised of treadmill walking in a laboratory setting while wearing the Dynamic AFO device.
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Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,744 Total Patients Enrolled
United States Department of DefenseFED
865 Previous Clinical Trials
327,677 Total Patients Enrolled
Joan E Sanders, PhDPrincipal InvestigatorUniversity of Washington
4 Previous Clinical Trials
372 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have a leg brace that is at least 200 mm long.I use my prescribed ankle-foot orthosis for over 20 hours a week.I use a special brace for my ankle and foot to help me walk or run.Requirements for all other people who want to participate in the study.I had surgery for a major leg injury over 6 months ago.You can run for 1 minute without stopping.You can run for 1 minute without stopping.
Research Study Groups:
This trial has the following groups:- Group 1: Aim 2
- Group 2: Aim 3
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.
Is this research venture open to recruitment?
"According to the clinicaltrials.gov database, this particular medical study is not searching for participants at present time. Initially posted on November 30th 2020, and last updated April 1st 2022; however 11 other trials are actively taking in patient recruits as we speak."
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