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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Illinois
Shirley Ryan AbilityLab
RECRUITING
Chicago
Contact Information
Primary
Joe Harris, DPT
jharris2@sralab.org
312-238-8425
Backup
Jennifer Bartloff, DPT, PhD
jbartloff@sralab.org
312-238-1562
Time Frame
Start Date: 2024-04-03
Estimated Completion Date: 2027-06
Participants
Target number of participants: 50
Treatments
Experimental: Arm AB: Variable Friction Shoe Training, AFO Training
Baseline (T0), 12 weeks Variable Friction Shoe Training, Follow-up (T1), 2-week washout, Follow-up (T2), 12 weeks AFO Training, Follow-up (T3)
Experimental: Arm BA: Ankle Foot Orthosis (AFO) Training, Variable Friction Shoe Training
Baseline (T0), 12 weeks AFO Training, Follow-up (T1), 2-week washout, Follow-up (T2), 12 weeks Variable Friction Shoe Training, Follow-up (T3)
Related Therapeutic Areas
Sponsors
Leads: Shirley Ryan AbilityLab
Collaborators: University of California, Santa Barbara, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov