Characterization and Clinical Trial of a Variable Friction Shoe
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShirley Ryan AbilityLab
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Variable Friction Shoe Training
- Ankle Foot Orthosis (AFO) Training
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Shirley Ryan AbilityLab
Lead sponsor
University of California, Santa Barbara
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov