Evaluation of a Variable Friction Shoe for Foot Drop After Stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a new low-cost medical device, the Variable Friction (VF) shoe, designed to assist individuals with foot drop following a stroke. The VF shoe features a high-friction outsole during the stance phase of gait and low friction during the swing phase, along with an auditory feedback mechanism to enhance gait safety and control. The study aims to characterize the shoe's effectiveness in reducing scuff-force and improving gait in chronic stroke patients, with participants undergoing training and assessments over a 12-week period. The research will also explore optimal fitting and training methods for the device in both clinical and home settings.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shirley Ryan AbilityLab
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Arun H Jayaraman, DPT, PhD — Shirley Ryan AbilityLab
• Study coordinator: Joe Harris, DPT
• Email: jharris2@sralab.org
• Phone: 312-238-8425

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

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• Dual-task balance training plus computer-based cognitive training after stroke

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.