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NOT YET RECRUITING
NCT07447934
NA

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

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

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

Official title: Vibrotactile Stimulation for Lower Limb Spasticity

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2026-04-01

Completion Date

2027-10-31

Last Updated

2026-03-24

Healthy Volunteers

No

Interventions

DEVICE

Vibrotactile Stimulation (Static Use)

The Vibrotactile Stimulation (VTS) device is a wearable, non-invasive therapeutic system designed to reduce spasticity and improve motor function in individuals with neurological impairments leading to lower limb spasticity. The device consists of a compact vibratory motor housed in a soft, adjustable strap that can be worn over targeted muscle groups (e.g., gastrocnemius/soleus complex). The stimulation is delivered at a predefined frequency and amplitude, optimized based on prior research to modulate spinal reflex pathways and reduce motoneuron hyperexcitability. The device will be worn during static conditions (e.g., standing or seated) and is intended for daily use at home or in-clinic.

DEVICE

Vibrotactile Stimulation (Dynamic Use)

The Vibrotactile Stimulation (VTS) device is a wearable, non-invasive therapeutic system designed to reduce spasticity and improve motor function in individuals with neurological impairments leading to lower limb spasticity. The device consists of a compact vibratory motor housed in a soft, adjustable strap that can be worn over targeted muscle groups (e.g., gastrocnemius/soleus complex). The stimulation is delivered at a predefined frequency and amplitude, optimized based on prior research to modulate spinal reflex pathways and reduce motoneuron hyperexcitability. The device will be used in dynamic conditions (e.g., walking) and is intended for daily use at home or in-clinic.

DEVICE

Vibrotactile Stimulation (Neurophysiological Mechanism)

The Vibrotactile Stimulation (VTS) device is a wearable, non-invasive therapeutic system designed to reduce spasticity and improve motor function in individuals with neurological impairments leading to lower limb spasticity. The device consists of a compact vibratory motor housed in a soft, adjustable strap that can be worn over targeted muscle groups (e.g., gastrocnemius/soleus complex). The stimulation is delivered at a predefined frequency and amplitude, optimized based on prior research to modulate spinal reflex pathways and reduce motoneuron hyperexcitability. The device will be used to investigate the neurophysiological mechanisms through which VTS modulates spasticity at different anatomical sites and its effectiveness on improving mobility. investigate the underlying neurophysiological mechanisms through which VTS modulates spasticity and muscle tone at different anatomical locations (i.e. muscle belly, origin, and insertion) around the leg and ankle.

Locations (1)

Department of Rehabilitation Medicine

New York, New York, United States