NCT07447934 Trial to Test the Effectiveness of Vibrotactile Stimulation for Lower Limb Spasticity
| NCT ID | NCT07447934 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Lower Limb Spasticity |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-04-30 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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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 25 participants in total. It began in 2026-04-30 with a primary completion date of 2027-06-30.
⚠ 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
The goal of this clinical trial is to find out if Vibrotactile Stimulation (VTS) can help improve mobility and reduce spasticity (muscle stiffness) in people with lower limb spasticity. The study will also look at how VTS affects walking speed. The main questions it aims to answer are: * Which areas of the body are the best for applying VTS? * Does VTS help improve walking speed in people with lower limb spasticity? Participants will: * Receive 15 minutes of VTS treatment on different parts of the body * Use the VTS device for 60 minutes during supervised lab sessions and at home (at rest and while walking) * Complete a daily log of how much time the device was used for and note any issues or difficulties the participant experience * Complete assessments after the treatment to measure change in mobility * Complete surveys about how comfortable the device is to use
Eligibility Criteria
Inclusion Criteria: * ≥6 months following neurologic diagnosis leading to spasticity * Modified Ashworth Scale (MAS) score of 3 or lower on ankle plantar flexor. * Ability to stand (with or without assistance) and lie supine. * Able to understand and comply with study procedures. Exclusion Criteria: * Uncontrolled systemic illness or serious medical conditions that could interfere with study procedures. * Previous surgery to treat spasticity in the affected lower limb. * Prior Botulinum Toxin (BoNT) therapy in the target limb within 4 months. * Unstable medication regimens for spasmolysis or muscle relaxation. * Participation in tone-related treatments (e.g., physiotherapy, TENS, acupuncture) within 4 weeks prior to baseline. If ongoing treatment started more than 4 weeks before baseline, it should remain consistent throughout the study
Contact & Investigator
Joan Stilling, M.D., M.S.
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT07447934 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Lower Limb Spasticity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07447934 currently recruiting?
Yes, NCT07447934 is actively recruiting participants. Visit ClinicalTrials.gov or contact Weill Medical College of Cornell University to inquire about joining.
Where is the NCT07447934 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07447934 clinical trial?
NCT07447934 is sponsored by Weill Medical College of Cornell University. The principal investigator is Joan Stilling, M.D., M.S. at Weill Medical College of Cornell University. The trial plans to enroll 25 participants.