RecruitingNot Applicable

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

United States25 participantsStarted 2026-04-30

Plain-language 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

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

H-reflex amplitude Baseline (Aim 1)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1

Modified Ashworth Scale at Screening

Timeframe: Screening Visit (-0 to 7 days prior to Aim 1 intervention)

Modified Ashworth Scale at Baseline (Aim 1)

Timeframe: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1

Trial details

NCT IDNCT07447934

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

View on ClinicalTrials.gov More Lower Limb Spasticity trials

Plain-language summary

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

H-reflex amplitude Baseline (Aim 1)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1

Modified Ashworth Scale at Screening

Timeframe: Screening Visit (-0 to 7 days prior to Aim 1 intervention)

Modified Ashworth Scale at Baseline (Aim 1)

Timeframe: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1