NCT06234124Recruiting
Characterization and Clinical Trial of a Variable Friction Shoe
Characterization and Clinical Trial of a Variable Friction Shoe, a New Paradigm of Reduced-constraint Locomotor Therapy for People Exhibiting Foot Drop Due to Stroke
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 22 Jan 2024
- Start date
- 3 Apr 2024
- Primary completion date
- Jan 2027
- Lead sponsor
- Shirley Ryan AbilityLab
- Diseases
- Stroke
- NCT number
- NCT06234124
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 3 Apr 2024 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of falling more than once a week prior to the stroke
- Not currently receiving botox to the lower extremities.
Other illness
- 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.
- Co-morbidity that interferes with the study (e.g. significant arthritis or joint problems, history of back injury, neuromuscular disorders, epilepsy, etc.).
Other
- 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)
- Severe deficits in cognition or communication
- Pregnant women (status determined by self-reporting).
- Severe Osteoporosis (status determined by self-reporting).
- Prisoners
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shirley Ryan AbilityLab Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.