Characterization and Clinical Trial of a Variable Friction Shoe

Description

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.

Conditions

Stroke

Study Overview

Study Details

Study overview

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.

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

Characterization and Clinical Trial of a Variable Friction Shoe

Condition
Stroke
Intervention / Treatment

-

Contacts and Locations

Chicago

Shirley Ryan AbilityLab, Chicago, Illinois, United States, 60611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Shirley Ryan AbilityLab,

Arun H Jayaraman, DPT, PhD, PRINCIPAL_INVESTIGATOR, Shirley Ryan AbilityLab

Study Record Dates

2027-06