Actively Recruiting
Characterization and Clinical Trial of a Variable Friction Shoe
Led by Shirley Ryan AbilityLab · Updated on 2026-05-11
50
Participants Needed
1
Research Sites
164 weeks
Total Duration
On this page
Sponsors
S
Shirley Ryan AbilityLab
Lead Sponsor
U
University of California, Santa Barbara
Collaborating Sponsor
AI-Summary
What this Trial Is About
More than one million Americans present with foot drop after stroke. As the aging population grows in the United States and across the world, incidence of stroke will grow as age is a key risk factor, thus there will be a need for low-cost, easy-to-use, and scalable solutions to administer proper therapy to promote recovery. This study will evaluate a Variable Friction shoe (VF shoe), a new low-cost medical device, for foot drop in an at-home setting.
CONDITIONS
Official Title
Characterization and Clinical Trial of a Variable Friction Shoe
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 3 months poststroke
- Age 18 or older
- Possess a prescribed AFO or be a potential candidate for use of an AFO
- Can ambulate at least 10 meters with or without an assistive device such as a cane or walker
- Medically stable as determined by physician medical clearance
- No expected change in medications for at least 3 months
- Adequate stability at the ankle during stance
- Ability to hear clicking noise made by the VF shoe
- Physician approval
- Ability to give informed consent
- Able to sit unsupported and follow a three-step command
- No unhealed or unresolved orthopedic injury to upper or lower extremities and no history of severe back pain
- English speaking
- Willing to follow an exercise program with both devices for at least 30 minutes per day, at least 5 days per week for 6 months
You will not qualify if you...
- History of falling more than once a week prior to the stroke
- Gait speed (self-selected velocity) greater than 1.2 m/s
- Inability to operate the devices safely without caregiver assistance
- Morbid obesity (body mass index greater than 40 kg/m2)
- Serious cardiac conditions, myocardial infarction, congestive heart failure, demand pacemaker, seizures, excessive dysesthetic pain, or severe lower extremity pathology interfering with device use
- Severe cognitive or communication deficits
- Pregnant women (self-reported)
- Co-morbidities interfering with the study such as significant arthritis, joint problems, back injury, neuromuscular disorders, epilepsy
- Severe osteoporosis (self-reported)
- Prisoners
- Currently receiving botox injections in the lower extremities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
J
Joe Harris, DPT
CONTACT
J
Jennifer Bartloff, DPT, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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