Adaptive, lightweight AFO that changes stiffness with activity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial will evaluate a variable-stiffness, auto-adjusting ankle-foot orthosis designed to reduce loading at the injury site while supporting gait. The device aims to adapt to different activities and user effort, potentially improving function without increasing joint stress proximally. Participants include individuals who already use prescribed offloading AFOs and meet safety requirements, with testing conducted at the University of Washington in collaboration with the Department of Defense. Outcomes will focus on device performance, user comfort, and ability to walk or run with the new brace. The study is conducted in a controlled lab setting with treadmill-based assessments to simulate real-world activity.

Why it matters

Who can join: the full rules

Inclusion Criteria (Healthy Volunteers):

-able to run continuously for 1 minute

Inclusion Criteria (All Other Volunteers)

* prescribed an offloading Ankle-Foot Orthosis (AFO) for walking/running
* Use prescribed offloading AFO at least 20 hours per week
* Prescribed AFO strut length of at least 200 mm
* Able to run continuously for 1 minute

Exclusion Criteria (Healthy Volunteers):

* limited sensation in the lower limbs
* use an assistive device

Exclusion Criteria (All Other Volunteers):

* Unable to ambulate (walk/run) continuously with AFO for at least 1 minute
* Unable to sit, stand, or negotiate a step onto lab treadmill

Where it's running

• University of Washington, Dept. of Bioengineering
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Joan E Sanders, PhD — University of Washington
• Study coordinator: Joan Sanders, PhD
• Email: jsanders@uw.edu
• Phone: 206-221-5872

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.