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
≥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.
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.
Crossover
Vibrotactile Stimulation (Static Use)
DeviceThe 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.
Vibrotactile Stimulation (Dynamic Use)
DeviceThe 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.
Vibrotactile Stimulation (Neurophysiological Mechanism)
DeviceThe 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.
H-reflex amplitude Baseline (Aim 1)
Assesses spinal reflex excitability as a neurophysiological indicator of spasticity modulation. μV amplitude; no fixed range.
H-reflex amplitude After Intervention (Aim 1)
Assesses spinal reflex excitability as a neurophysiological indicator of spasticity modulation. μV amplitude; no fixed range.
Surface EMG activity of gastrocnemius/soleus Baseline (Aim 1)
Measures muscle activation patterns in gastrocnemius/soleus to evaluate VTS effects. μV amplitude; no fixed range.
Surface EMG activity of gastrocnemius/soleus After Intervention (Aim 1)
Measures muscle activation patterns in gastrocnemius/soleus to evaluate VTS effects. μV amplitude; no fixed range.
Timed up and go (TUG) at Baseline (Aim 2)
Assesses walking endurance and functional mobility over a longer duration.Distance in meters; higher is better.
Timed up and go (TUG) After Intervention (Aim 2)
Assesses walking endurance and functional mobility over a longer duration.Distance in meters; higher is better.
Two minute walk test (TMWT) at Baseline (Aim 2)
Assesses functional mobility, balance, and fall risk. Time (s); lower is better.
Two minute walk test (TMWT) After Intervention (Aim 2)
Assesses functional mobility, balance, and fall risk. Time (s); lower is better.
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Weill Medical College of Cornell University
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
