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

June 15, 2026 updated by: Weill Medical College of Cornell University

Vibrotactile Stimulation for Lower Limb Spasticity

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Department of Rehabilitation Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Assesses spinal reflex excitability as a neurophysiological indicator of spasticity modulation. μV amplitude; no fixed range.
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)
Time Frame: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Assesses spinal reflex excitability as a neurophysiological indicator of spasticity modulation. μV amplitude; no fixed range.
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)
Time Frame: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Measures muscle activation patterns in gastrocnemius/soleus to evaluate VTS effects. μV amplitude; no fixed range.
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)
Time Frame: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Measures muscle activation patterns in gastrocnemius/soleus to evaluate VTS effects. μV amplitude; no fixed range.
Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Modified Ashworth Scale at Screening
Time Frame: Screening Visit (-0 to 7 days prior to Aim 1 intervention)
Assesses muscle tone and spasticity, especially in ankle plantarflexors.Total score ranges from: 0 (no increase in tone) to 4 (rigid in flexion/extension).
Screening Visit (-0 to 7 days prior to Aim 1 intervention)
Modified Ashworth Scale at Baseline (Aim 1)
Time Frame: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for 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).
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)
Time Frame: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for 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).
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)
Time Frame: Baseline measurement immediately before intervention for 3 consecutive days for 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).
Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Modified Ashworth Scale After Intervention (Aim 2)
Time Frame: Immediately after intervention for 3 consecutive days for 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).
Immediately after intervention for 3 consecutive days for Aim 2
Passive range of motion at the ankle at Screening
Time Frame: Screening Visit (-0 to 7 days prior to Aim 1 intervention)
Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility
Screening Visit (-0 to 7 days prior to Aim 1 intervention)
Passive range of motion at the ankle at Baseline (Aim 1)
Time Frame: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility
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)
Time Frame: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1
Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility
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)
Time Frame: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility
Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Passive range of motion at the ankle After Intervention (Aim 2)
Time Frame: Immediately after intervention for 3 consecutive days for Aim 2
Evaluates joint flexibility, particularly at the ankle. Range:Degrees; higher indicates greater flexibility
Immediately after intervention for 3 consecutive days for Aim 2
10 meter walk test at Baseline (Aim 2)
Time Frame: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Measures gait speed over a short distance; primary measure of functional mobility. Time is in seconds; lower is better.
Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
10 meter walk test at Baseline After Intervention (Aim 2)
Time Frame: Immediately after intervention for 3 consecutive days for Aim 2
Measures gait speed over a short distance; primary measure of functional mobility. Time is in seconds; lower is better.
Immediately after intervention for 3 consecutive days for Aim 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Timed up and go (TUG) at Baseline (Aim 2)
Time Frame: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Assesses walking endurance and functional mobility over a longer duration.Distance in meters; higher is better.
Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Timed up and go (TUG) After Intervention (Aim 2)
Time Frame: Immediately after intervention for 3 consecutive days for Aim 2
Assesses walking endurance and functional mobility over a longer duration.Distance in meters; higher is better.
Immediately after intervention for 3 consecutive days for Aim 2
Two minute walk test (TMWT) at Baseline (Aim 2)
Time Frame: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Assesses functional mobility, balance, and fall risk. Time (s); lower is better.
Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Two minute walk test (TMWT) After Intervention (Aim 2)
Time Frame: Immediately after intervention for 3 consecutive days for Aim 2
Assesses functional mobility, balance, and fall risk. Time (s); lower is better.
Immediately after intervention for 3 consecutive days for Aim 2
Berg Balance Scale (BBS) at Baseline (Aim 2)
Time Frame: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Evaluates balance performance using a 14-item scale. Range: 0 to 56; higher scores indicate better balance.
Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Berg Balance Scale (BBS) After Intervention (Aim 2)
Time Frame: Immediately after intervention for 3 consecutive days for Aim 2
Evaluates balance performance using a 14-item scale. Range: 0 to 56; higher scores indicate better balance.
Immediately after intervention for 3 consecutive days for Aim 2
Global Impression of Change Scale (GICS) at Baseline (Aim 2)
Time Frame: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Self-reported measure of overall perceived improvement. Range: 1 (very much worse) to 7 (very much improved.
Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Global Impression of Change Scale (GICS) After Intervention (Aim 2)
Time Frame: Immediately after intervention for 3 consecutive days for Aim 2
Self-reported measure of overall perceived improvement. Range: 1 (very much worse) to 7 (very much improved.
Immediately after intervention for 3 consecutive days for Aim 2
Short form 12 (SF12) at Baseline (Aim 2)
Time Frame: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Assesses health-related quality of life across physical and mental domains. Range: 0 to 100 per domain; higher is better
Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Short form 12 (SF12) After Intervention (Aim 2)
Time Frame: Immediately after intervention for 3 consecutive days for Aim 2
Assesses health-related quality of life across physical and mental domains. Range: 0 to 100 per domain; higher is better
Immediately after intervention for 3 consecutive days for Aim 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Advancing Translational Sciences (NCATS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joan Stilling, M.D., M.S., Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-07029051
  • UL1TR002384 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Following publication of the primary outcomes manuscript and completion of all planned analyses. Data will be available for up to 6 years after study completion.

IPD Sharing Access Criteria

Qualified investigators affiliated with academic, clinical, or non-profit research institutions who submit a scientifically sound proposal consistent with the aims of the original study. Data will be made available through a controlled access process. Interested researchers should contact the Principal Investigator via institutional email. Approved applicants must sign a Data Use Agreement outlining terms of use, data protection requirements, and agreement to destroy data after the completion of approved analyses.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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