Lower Limb SpasticityNCT07447934
Trial to Test the Effectiveness of Vibrotactile Stimulation for Lower Limb Spasticity
A study testing Vibrotactile Stimulation (Static Use), Vibrotactile Stimulation (Dynamic Use) and Vibrotactile Stimulation (Neurophysiological Mechanism) in people with Lower Limb Spasticity, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lower Limb Spasticity
- What is being tested?
- Vibrotactile Stimulation (Static Use), Vibrotactile Stimulation (Dynamic Use) and Vibrotactile Stimulation (Neurophysiological Mechanism)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Medicine
New York, New York, 10065
Joan Stilling, MD., MS., 212-746-1500, qsi9001@med.cornell.edu
About this study
Official title: 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?
Read more
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
Read the 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.
- Conditions
- Lower Limb Spasticity
- Being tested
- Vibrotactile Stimulation (Static Use), Vibrotactile Stimulation (Dynamic Use), Vibrotactile Stimulation (Neurophysiological Mechanism)
- Keywords
- mobility, lower limb, spasticity, walking endurance, home device, quality of life, vts, LLS, gait, stroke
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Vibrotactile Stimulation (Neurophysiological Mechanism) |
What is being measured
The primary outcome is the main question the study is designed to answer.
H-reflex amplitude Baseline (Aim 1)
Assesses spinal reflex excitability as a neurophysiological indicator of spasticity modulation. μV amplitude; no fixed range.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Immediately after intervention for 3 consecutive days for Aim 2
Secondary outcomes (10)
Timed up and go (TUG) at Baseline (Aim 2)
Assesses walking endurance and functional mobility over a longer duration.Distance in meters; higher is better.
Measured: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Timed up and go (TUG) After Intervention (Aim 2)
Assesses walking endurance and functional mobility over a longer duration.Distance in meters; higher is better.
Measured: Immediately after intervention for 3 consecutive days for Aim 2
Two minute walk test (TMWT) at Baseline (Aim 2)
Assesses functional mobility, balance, and fall risk. Time (s); lower is better.
Measured: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Two minute walk test (TMWT) After Intervention (Aim 2)
Assesses functional mobility, balance, and fall risk. Time (s); lower is better.
Measured: Immediately after intervention for 3 consecutive days for Aim 2
Berg Balance Scale (BBS) at Baseline (Aim 2)
Evaluates balance performance using a 14-item scale. Range: 0 to 56; higher scores indicate better balance.
Measured: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Berg Balance Scale (BBS) After Intervention (Aim 2)
Evaluates balance performance using a 14-item scale. Range: 0 to 56; higher scores indicate better balance.
Measured: Immediately after intervention for 3 consecutive days for Aim 2
Global Impression of Change Scale (GICS) at Baseline (Aim 2)
Self-reported measure of overall perceived improvement. Range: 1 (very much worse) to 7 (very much improved.
Measured: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Global Impression of Change Scale (GICS) After Intervention (Aim 2)
Self-reported measure of overall perceived improvement. Range: 1 (very much worse) to 7 (very much improved.
Measured: Immediately after intervention for 3 consecutive days for Aim 2
Short form 12 (SF12) at Baseline (Aim 2)
Assesses health-related quality of life across physical and mental domains. Range: 0 to 100 per domain; higher is better
Measured: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2
Short form 12 (SF12) After Intervention (Aim 2)
Assesses health-related quality of life across physical and mental domains. Range: 0 to 100 per domain; higher is better
Measured: Immediately after intervention for 3 consecutive days for Aim 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start30 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Lower Limb SpasticityStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Joan Stilling, M.D., M.S., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447934
- Sponsor's protocol ID
- 25-07029051
- Other IDs
- UL1TR002384
- Status last verified
- Jun 2026
- First submitted
- 25 Feb 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 30690609Seim 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.
PubMed 33485371Seim 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.
PubMed 35552152Kodama 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.
PubMed 30914938Khalifeloo 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.
PubMed 29740561Fari 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.
PubMed 37754303Enders 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.
PubMed 24112371Caliandro 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.
PubMed 22507444Bark 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.
PubMed 25486644Alashram, 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
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.
PubMed 29661237Afzal 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.
PubMed 31247557
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibrotactile Stimulation for Lower Limb Spasticity
- ClinicalTrials.gov ID
- NCT07447934
- Acronym / sponsor ID
- 25-07029051
- Conditions
- Lower Limb Spasticity
- Keywords
- mobility, lower limb, spasticity, walking endurance, home device, quality of life, vts, LLS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| VTS Static Use, then Dynamic Use (Aim 2) | Experimental | Device: Vibrotactile Stimulation (Static Use)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. |
| VTS Dynamic Use, then Static Use (Aim 2) | Experimental | Device: Vibrotactile Stimulation (Dynamic Use)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. |
| VTS Neurophysiological Mechanism (Aim 1) | Other | Device: Vibrotactile Stimulation (Neurophysiological Mechanism)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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | VTS Static Use, then Dynamic Use (Aim 2) |
| 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. | Device | VTS Dynamic Use, then Static Use (Aim 2) |
| 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. | Device | VTS Neurophysiological Mechanism (Aim 1) |
Primary outcome
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.
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.
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.
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.
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).
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).
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).
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).
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).
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
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
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
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
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
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.
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.
10 secondary outcomes
Timed up and go (TUG) at Baseline (Aim 2)
Time frame: 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
Two minute walk test (TMWT) at Baseline (Aim 2)
Time frame: 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
Berg Balance Scale (BBS) at Baseline (Aim 2)
Time frame: 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
Global Impression of Change Scale (GICS) at Baseline (Aim 2)
Time frame: 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
Short form 12 (SF12) at Baseline (Aim 2)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 30690609Seo 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.
- Background: PubMed 33485371Seim 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.
- Background: PubMed 35552152Seim 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.
- Background: PubMed 30914938Kodama 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.
- Background: PubMed 29740561Khalifeloo 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.
- Background: PubMed 37754303Fari 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.
- Background: PubMed 24112371Enders 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.
- Background: PubMed 22507444Caliandro 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.
- Background: PubMed 25486644Bark 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.
- BackgroundAlashram, 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: PubMed 29661237Afzal 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.
- Background: PubMed 31247557Afzal 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joan Stilling, M.D., M.S. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrotactile Stimulation (Static Use), Vibrotactile Stimulation (Dynamic Use) and Vibrotactile Stimulation (Neurophysiological Mechanism) in people with Lower Limb Spasticity, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07447934, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.