Evaluation of a Variable Friction Shoe for Foot Drop After Stroke
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
NA · Shirley Ryan AbilityLab · NCT06234124
This study is testing a new shoe designed to help people with foot drop after a stroke walk better and feel more stable.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06234124 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older who are at least three months post-stroke and can ambulate at least 10 meters with or without an assistive device.
Not a fit: Patients with a history of frequent falls prior to their stroke or those with unresolved orthopedic injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mobility and reduce the risk of falls for stroke survivors with foot drop.
How similar studies have performed: While the concept of using variable friction devices is innovative, similar studies have shown promise in improving mobility for patients with gait impairments.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke