NCT06234124 Characterization and Clinical Trial of a Variable Friction Shoe
| NCT ID | NCT06234124 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shirley Ryan AbilityLab |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-04-03 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-04-03 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Arun H Jayaraman, DPT, PhD
PRINCIPAL INVESTIGATOR
Shirley Ryan AbilityLab
Frequently Asked Questions
Who can join the NCT06234124 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06234124 currently recruiting?
Yes, NCT06234124 is actively recruiting participants. Contact the research team at jharris2@sralab.org for enrollment information.
Where is the NCT06234124 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06234124 clinical trial?
NCT06234124 is sponsored by Shirley Ryan AbilityLab. The principal investigator is Arun H Jayaraman, DPT, PhD at Shirley Ryan AbilityLab. The trial plans to enroll 50 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.