Recruiting

Vibrotactile Stimulation

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07447934

Conditions

Lower Limb Spasticity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Vibrotactile Stimulation (Static Use)

Vibrotactile Stimulation (Dynamic Use)

Vibrotactile Stimulation (Neurophysiological Mechanism)

Study Details

Brief 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

Conditions

Lower Limb Spasticity

Study ID

NCT07447934

Start date

Apr 30, 2026

Status verified date

Jun, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

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.

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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Modified Ashworth Scale at Screening [ Time Frame: 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 ]
  • 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 ]
  • Modified Ashworth Scale at Baseline (Aim 2) [ Time Frame: 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 ]
  • Passive range of motion at the ankle at Screening [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • Passive range of motion at the ankle After Intervention (Aim 2) [ Time Frame: 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 ]
  • 10 meter walk test at Baseline After Intervention (Aim 2) [ Time Frame: Immediately after intervention for 3 consecutive days for Aim 2 ]

Central Contacts and Locations

Locations

Department of Rehabilitation Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Joan Stilling, MD., MS.

212-746-1500qsi9001@med.cornell.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • mobility
  • lower limb
  • spasticity
  • walking endurance
  • home device
  • quality of life
  • vts
  • LLS
  • gait
  • stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-06-17.