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Characterization and Clinical Trial of a Variable Friction Shoe

Sponsored by Shirley Ryan AbilityLab

About this study

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.

The investigators propose an alternative strategy that addresses the hazard of tripping even while allowing full volitional control of the ankle: an inexpensive Variable Friction (VF) shoe. Its outsole is high-friction during the stance phase of gait and low friction during swing; further, it produces a "click" when a scuff occurs. The investigator's central hypothesis is that allowing volitional motion of the ankle while mitigating the hazard of tripping coupled with gait-phased auditory biofeedback will result in improved gait for subjects with drop foot. Specifically, the investigators hypothesize that the VF shoe will show significantly greater therapeutic effects than an AFO, yet maintain the desirable orthotic effect of the AFO. The study is arranged in two Aims. Exploratory Aim: I…

Where this study is enrolling

Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.