An interventional study of Vibrotactile Stimulation (Static Use) and Vibrotactile Stimulation (Dynamic Use) in Lower Limb Spasticity, sponsored by Weill Medical College of Cornell University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's planned enrollment of 25 is below the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
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Exclusion Criteria:
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.
Device: Vibrotactile Stimulation (Static Use)
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.
Device: Vibrotactile Stimulation (Dynamic Use)
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.
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 worn during static conditions (e.g., standing or seated) and is intended for daily use at home or in-clinic.
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.
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.
H-reflex amplitude Baseline (Aim 1)
Assesses spinal reflex excitability as a neurophysiological indicator of spasticity modulation. μV amplitude; no fixed range.
Time frame: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1
H-reflex amplitude After Intervention (Aim 1)
Assesses spinal reflex excitability as a neurophysiological indicator of spasticity modulation. μV amplitude; no fixed range.
Time frame: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1
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.
Time frame: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1
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.
Time frame: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Modified Ashworth Scale at Screening
Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).
Time frame: Screening Visit (-0 to 7 days prior to Aim 1 intervention)
Modified Ashworth Scale at Baseline (Aim 1)
Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).
Time frame: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Modified Ashworth Scale After Intervention (Aim 1)
Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).
Time frame: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Modified Ashworth Scale at Baseline (Aim 2)
Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).
Time frame: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Modified Ashworth Scale After Intervention (Aim 2)
Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).
Time frame: Immediately after intervention for 3 consecutive days for Aim 2
Passive range of motion at the ankle at Screening
Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility
Time frame: Screening Visit (-0 to 7 days prior to Aim 1 intervention)
Passive range of motion at the ankle at Baseline (Aim 1)
Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility
Time frame: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Passive range of motion at the ankle After Intervention (Aim 1)
Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility
Time frame: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Passive range of motion at the ankle at Baseline (Aim 2)
Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility
Time frame: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Passive range of motion at the ankle After Intervention (Aim 2)
Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility
Time frame: Immediately after intervention for 3 consecutive days for Aim 2
10 meter walk test at Baseline (Aim 2)
Measures gait speed over a short distance; primary measure of functional mobility. Time is in seconds; lower is better.
Time frame: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
10 meter walk test at Baseline After Intervention (Aim 2)
Measures gait speed over a short distance; primary measure of functional mobility. Time is in seconds; lower is better.
Time frame: Immediately after intervention for 3 consecutive days for Aim 2
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.
Time frame: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
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.
Time frame: Immediately after intervention for 3 consecutive days for Aim 2
Two minute walk test (TMWT) at Baseline (Aim 2)
Assesses functional mobility, balance, and fall risk. Time (s); lower is better.
Time frame: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Two minute walk test (TMWT) After Intervention (Aim 2)
Assesses functional mobility, balance, and fall risk. Time (s); lower is better.
Time frame: Immediately after intervention for 3 consecutive days for Aim 2
Berg Balance Scale (BBS) at Baseline (Aim 2)
Evaluates balance performance using a 14-item scale. Range: 0 to 56; higher scores indicate better balance.
Time frame: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Berg Balance Scale (BBS) After Intervention (Aim 2)
Evaluates balance performance using a 14-item scale. Range: 0 to 56; higher scores indicate better balance.
Time frame: Immediately after intervention for 3 consecutive days for Aim 2
Global Impression of Change Scale (GICS) at Baseline (Aim 2)
Self-reported measure of overall perceived improvement. Range: 1 (very much worse) to 7 (very much improved.
Time frame: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Global Impression of Change Scale (GICS) After Intervention (Aim 2)
Self-reported measure of overall perceived improvement. Range: 1 (very much worse) to 7 (very much improved.
Time frame: Immediately after intervention for 3 consecutive days for Aim 2
Short form 12 (SF12) at Baseline (Aim 2)
Assesses health-related quality of life across physical and mental domains. Range: 0 to 100 per domain; higher is better
Time frame: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Short form 12 (SF12) After Intervention (Aim 2)
Assesses health-related quality of life across physical and mental domains. Range: 0 to 100 per domain; higher is better
Time frame: Immediately after intervention for 3 consecutive days for Aim 2
Plan to share: Yes — De-identified participant-level data including demographic information, baseline and post-intervention assessments of spasticity, EMG/H-reflex measures, and functional outcomes (e.g., 10-Meter Walk Test, Modified Ashworth Scale). No direct identifiers or protected health information will be included.
Supporting information: Study protocol, Icf
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Weill Medical College of Cornell University