Characterization and Clinical Trial of a Variable Friction Shoe

Launched by SHIRLEY RYAN ABILITYLAB · Jan 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new type of shoe called the Variable Friction shoe (VF shoe) designed to help people who have foot drop after a stroke. Foot drop is a common condition where individuals have difficulty lifting their foot, which can make walking challenging. The trial aims to see how well this affordable shoe works for helping patients regain their ability to walk more easily, all while they are at home.

To participate, you must be at least 18 years old and have had a stroke between three months and one year ago. You should be able to walk at least 10 meters, either with or without a walking aid like a cane or walker, and be medically cleared by your doctor. If you join the trial, you’ll wear the VF shoe and follow a simple exercise program for six months to help improve your walking. It's important to note that participants should be English-speaking and able to follow basic instructions. Overall, this trial hopes to provide a practical solution for many stroke survivors looking to improve their mobility.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. At least 3 months poststroke
• • 2. Age 18 or older
• • 3. Possess a prescribed AFO or be a potential candidate for use of an AFO
• • 4. Can ambulate at least 10m with or without an assistive device such as a cane or walker
• • 5. Medically stable as determined by physician medical clearance
• • 6. No expected change in medications for at least 3 months
• • 7. Adequate stability at the ankle during stance
• • 8. Ability to hear clicking noise made by the VF shoe
• • 9. Physician approval
• • 10. Ability to give informed consent
• • 11. Able to sit unsupported and be able to follow a three-step command
• • 12. No unhealed/unresolved orthopedic injury to either upper or lower extremity and no history of severe back pain
• • 13. English speaking
• • 14. 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)
• Exclusion Criteria:
• • 1. History of falling more than once a week prior to the stroke
• • 2. Gait speed: self-selected velocity (SSV) greater than 1.2 m/s
• • 3. Inability to operate in the devices safely and no caregiver assistance available
• • 4. Morbid obesity (body mass index \>40 kg/m2)
• • 5. 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.
• • 6. Severe deficits in cognition or communication
• • 7. Pregnant women (status determined by self-reporting).
• • 8. Co-morbidity that interferes with the study (e.g. significant arthritis or joint problems, history of back injury, neuromuscular disorders, epilepsy, etc.).
• • 9. Severe Osteoporosis (status determined by self-reporting).
• • 10. Prisoners
• • 11. Not currently receiving botox to the lower extremities.

Trial Officials