Trial to Test the Effectiveness of Vibrotactile Stimulation for Lower Limb Spasticity

Recruiting now · Not applicable

Conditions studied: Lower Limb Spasticity

In brief

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

Key facts

Study ID

NCT07447934

Run by

Weill Medical College of Cornell University

People needed

25

Starts

2026-04-30

Expected to finish

2027-10-31

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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.

You may not qualify if…

• 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

Where it is running

• Department of Rehabilitation Medicine — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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