Characterization and Clinical Trial of a Variable Friction Shoe
Recruiting now · Not applicable
Conditions studied: Stroke
In brief
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.
Key facts
- Study ID
- NCT06234124
- Run by
- Shirley Ryan AbilityLab
- People needed
- 50
- Starts
- 2024-04-03
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 10m 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 be able to follow a three-step command
- No unhealed/unresolved orthopedic injury to either upper or lower extremity 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 the full length of the program (6 months)
You may not qualify if…
- History of falling more than once a week prior to the stroke
- Gait speed: self-selected velocity (SSV) greater than 1.2 m/s
- Inability to operate in the devices safely and no caregiver assistance available
- Morbid obesity (body mass index >40 kg/m2)
- Preexisting conditions such as serious cardiac conditions, myocardial infarction, congestive heart failure, demand pacemaker, seizures, excessive dysesthetic pain, and severe lower extremity pathology that would interfere with fit or use of the shoe.
- Severe deficits in cognition or communication
- Pregnant women (status determined by self-reporting).
- Co-morbidity that interferes with the study (e.g. significant arthritis or joint problems, history of back injury, neuromuscular disorders, epilepsy, etc.).
- Severe Osteoporosis (status determined by self-reporting).
- Prisoners
- Not currently receiving botox to the lower extremities.
Where it is running
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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