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NCT Number: NCT07447934

Trial to Test the Effectiveness of 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

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Key information

Conditions

Lower Limb Spasticity Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation Medicine

New York, 10065, United States

Location status: Recruiting

Location contact

Joan Stilling, MD., MS.

CONTACT

[email protected]

212-746-1500

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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.

  16. 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.

Secondary outcomes

  1. 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.

  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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Vibrotactile Stimulation for Lower Limb Spasticity

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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