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Characterization and Clinical Trial of a Variable Friction Shoe
Sponsor: Shirley Ryan AbilityLab
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-04-03
Completion Date
2027-06
Last Updated
2024-11-25
Healthy Volunteers
No
Conditions
Interventions
Variable Friction Shoe Training
The experimental group (A) will be given a pair of VF shoes and instructed to use shoes on both feet. This group will be instructed to walk on hard surfaces to engage auditory feedback of the VF shoes. This group group will be monitored daily using actigraphy and will receive weekly check-up telephone calls by a member of the research team to record number of steps, walking time, a scale for self-identified effort and perceived safety levels.
Ankle Foot Orthosis (AFO) Training
The control group (B) will be provided an AFO to use on the paretic limb. This group will be instructed to walk on hard surfaces. This group group will be monitored daily using actigraphy and will receive weekly check-up telephone calls by a member of the research team to record number of steps, walking time, a scale for self-identified effort and perceived safety levels.
Locations (1)
Shirley Ryan AbilityLab
Chicago, Illinois, United States