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

Conditions

• Lower Limb Spasticity

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Vibrotactile Stimulation (Static Use) — DEVICE
  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.
• Vibrotactile Stimulation (Dynamic Use) — DEVICE
  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.
• Vibrotactile Stimulation (Neurophysiological Mechanism) — DEVICE
  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.

Study Details

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 Dates

Start date

Apr 1, 2026

Status verified

Mar 2026

Primary completion

Jun 30, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

25 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: VTS Static Use, then Dynamic Use (Aim 2)
  The participant will first use the VTS device for 60 minutes daily for three consecutive days while in a static position. After a washout period of 1 week, the participant will use the VTS device for 60 minutes daily for three consecutive days during active gait training.
• Experimental: VTS Dynamic Use, then Static Use (Aim 2)
  The participant will first use the VTS device for 60 minutes daily for three consecutive days during active gait training. After a washout period of 1 week, the participant will use the VTS device for 60 minutes daily for three consecutive days while in a static position.
• Other: VTS Neurophysiological Mechanism (Aim 1)
  The participant will use the VTS device for three 15-minutes sessions, once for each anatomical locations (i.e. muscle belly, origin, and insertion) around the leg and ankle.

Primary Outcome Measure

H-reflex amplitude Baseline (Aim 1) [ Time Frame: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1 ]

Locations (1)

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