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

NCT07447934 | Recruiting FDA Device

• 2 other identifiers: 25-07029051UL1TR002384
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (16)

• H-reflex amplitude Baseline (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)

  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)

  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)

  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

  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)

  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)

  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)

  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)

  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

  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)

  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)

  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)

  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)

  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)

  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)

  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 Outcomes (10)

• Timed up and go (TUG) at Baseline (Aim 2)

  Baseline measurement immediately before intervention for 3 consecutive days for Aim 2

• Timed up and go (TUG) After Intervention (Aim 2)

  Immediately after intervention for 3 consecutive days for Aim 2

• Two minute walk test (TMWT) at Baseline (Aim 2)

  Baseline measurement immediately before intervention for 3 consecutive days for Aim 2

• Two minute walk test (TMWT) After Intervention (Aim 2)

  Immediately after intervention for 3 consecutive days for Aim 2

• Berg Balance Scale (BBS) at Baseline (Aim 2)

  Baseline measurement immediately before intervention for 3 consecutive days for Aim 2

Study Arms (3)

VTS Static Use, then Dynamic Use (Aim 2)

EXPERIMENTAL

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)

VTS Dynamic Use, then Static Use (Aim 2)

EXPERIMENTAL

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)

VTS Neurophysiological Mechanism (Aim 1)

OTHER

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)

Interventions

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.

VTS Static Use, then Dynamic Use (Aim 2)

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.

VTS Dynamic Use, then Static Use (Aim 2)

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.

VTS Neurophysiological Mechanism (Aim 1)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Department of Rehabilitation Medicine

New York, New York, 10065, United States

RECRUITING

Related Publications (12)

• Seo NJ, Woodbury ML, Bonilha L, Ramakrishnan V, Kautz SA, Downey RJ, Dellenbach BHS, Lauer AW, Roark CM, Landers LE, Phillips SK, Vatinno AA. TheraBracelet Stimulation During Task-Practice Therapy to Improve Upper Extremity Function After Stroke: A Pilot Randomized Controlled Study. Phys Ther. 2019 Mar 1;99(3):319-328. doi: 10.1093/ptj/pzy143.

  PMID: 30690609 BACKGROUND

• Seim CE, Wolf SL, Starner TE. Wearable vibrotactile stimulation for upper extremity rehabilitation in chronic stroke: clinical feasibility trial using the VTS Glove. J Neuroeng Rehabil. 2021 Jan 23;18(1):14. doi: 10.1186/s12984-021-00813-7.

  PMID: 33485371 BACKGROUND

• Seim CE, Ritter B, Starner TE, Flavin K, Lansberg MG, Okamura AM. Design of a Wearable Vibrotactile Stimulation Device for Individuals With Upper-Limb Hemiparesis and Spasticity. IEEE Trans Neural Syst Rehabil Eng. 2022;30:1277-1287. doi: 10.1109/TNSRE.2022.3174808. Epub 2022 May 17.

  PMID: 35552152 BACKGROUND

• Kodama K, Yasuda K, Kuznetsov NA, Hayashi Y, Iwata H. Balance Training With a Vibrotactile Biofeedback System Affects the Dynamical Structure of the Center of Pressure Trajectories in Chronic Stroke Patients. Front Hum Neurosci. 2019 Mar 12;13:84. doi: 10.3389/fnhum.2019.00084. eCollection 2019.

  PMID: 30914938 BACKGROUND

• Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.

  PMID: 29740561 BACKGROUND

• Fari G, Ranieri M, Marvulli R, Dell'Anna L, Fai A, Tognolo L, Bernetti A, Caforio L, Megna M, Losavio E. Is There a New Road to Spinal Cord Injury Rehabilitation? A Case Report about the Effects of Driving a Go-Kart on Muscle Spasticity. Diseases. 2023 Aug 22;11(3):107. doi: 10.3390/diseases11030107.

  PMID: 37754303 BACKGROUND

• Enders LR, Hur P, Johnson MJ, Seo NJ. Remote vibrotactile noise improves light touch sensation in stroke survivors' fingertips via stochastic resonance. J Neuroeng Rehabil. 2013 Oct 11;10:105. doi: 10.1186/1743-0003-10-105.

  PMID: 24112371 BACKGROUND

• Caliandro P, Celletti C, Padua L, Minciotti I, Russo G, Granata G, La Torre G, Granieri E, Camerota F. Focal muscle vibration in the treatment of upper limb spasticity: a pilot randomized controlled trial in patients with chronic stroke. Arch Phys Med Rehabil. 2012 Sep;93(9):1656-61. doi: 10.1016/j.apmr.2012.04.002. Epub 2012 Apr 13.

  PMID: 22507444 BACKGROUND

• Bark K, Hyman E, Tan F, Cha E, Jax SA, Buxbaum LJ, Kuchenbecker KJ. Effects of vibrotactile feedback on human learning of arm motions. IEEE Trans Neural Syst Rehabil Eng. 2015 Jan;23(1):51-63. doi: 10.1109/TNSRE.2014.2327229. Epub 2014 Jun 2.

  PMID: 25486644 BACKGROUND

• Alashram, A. and Annino, G. (2022). Focal muscle vibration reduces spasticity and improves functional level in incomplete spinal cord injury: a case report. Physikalische Medizin Rehabilitationsmedizin Kurortmedizin, 33(03), 162-165. https://doi.org/10.1055/a-1819-6874

  BACKGROUND

• Afzal MR, Pyo S, Oh MK, Park YS, Yoon J. Evaluating the effects of delivering integrated kinesthetic and tactile cues to individuals with unilateral hemiparetic stroke during overground walking. J Neuroeng Rehabil. 2018 Apr 16;15(1):33. doi: 10.1186/s12984-018-0372-0.

  PMID: 29661237 BACKGROUND

• Afzal MR, Lee H, Eizad A, Lee CH, Oh MK, Yoon J. Effects of Vibrotactile Biofeedback Coding Schemes on Gait Symmetry Training of Individuals With Stroke. IEEE Trans Neural Syst Rehabil Eng. 2019 Aug;27(8):1617-1625. doi: 10.1109/TNSRE.2019.2924682. Epub 2019 Jun 24.

  PMID: 31247557 BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Joan Stilling, M.D., M.S.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Given the nature of the intervention (wearable vibrotactile stimulation), full participant blinding is not feasible. However, bias will be minimized through the following: Outcome assessments (e.g., 10MWT, MAS, TUG) will be performed by blinded raters who are not involved in administering the intervention and will remain unaware of the VTS condition. Participants will be instructed not to disclose their condition to outcome assessors. Statistical analysis will be conducted by team members who are blinded to the intervention sequence.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Aim 1 is a within-subject, counterbalanced mechanistic study evaluating neurophysiological effects of VTS applied to three anatomical sites. Aim 2 is a randomized crossover trial comparing the effects of VTS during (a) static positioning and (b) dynamic gait training, each applied over 3 consecutive daily sessions with a one-week washout period between conditions. This study includes a randomized, two-period crossover design in Aim 2, in which each participant will undergo two VTS conditions: (1) static use (resting position) and (2) dynamic use (during gait training). The order of these two intervention phases will be randomized to minimize order effects and participant-specific bias. Participants will be randomized in a 1:1 ratio to one of two sequences: Sequence A: Static VTS → Washout → Gait VTS Sequence B: Gait VTS → Washout → Static VTS

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 4, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• 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.

Locations

US (1)