NCT07447934NARecruiting

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

Weill Medical College of Cornell University

Start Date

4/30/2026

Completion Date

10/31/2027

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

Detailed Description

This study will investigate both the neurophysiological mechanisms and clinical effects of VTS in individuals with poststroke lower limb spasticity. Aim 1 will assess how different anatomical placements of VTS impact neuromuscular activity and spasticity. Aim 2 will test the feasibility and efficacy of VTS during both static and dynamic gait contexts using a randomized crossover design.

Eligibility Criteria

Age Range: 18 years to 85 years

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

Interventions

DEVICE

Vibrotactile Stimulation (Static Use)

DEVICE

Vibrotactile Stimulation (Dynamic Use)

DEVICE

Vibrotactile Stimulation (Neurophysiological Mechanism)

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Conditions

Lower Limb Spasticity

Locations

Department of Rehabilitation Medicine

New York, New York 10065

United States