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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR002384 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline measurement immediately before intervention for 3 consecutive days for Aim 2 |
| Timed up and go (TUG) After Intervention (Aim 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan Stilling, M.D., M.S. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rehabilitation Medicine | Recruiting | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30690609 | Background | 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. | |
| 33485371 | 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. |
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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.
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.
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.
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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
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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.
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| 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. |
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| 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. |
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| 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 |
Assesses walking endurance and functional mobility over a longer duration.Distance in meters; higher is better. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | Immediately after intervention for 3 consecutive days for Aim 2 |
| 35552152 | 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. |
| 30914938 | 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. |
| 29740561 | 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. |
| 37754303 | 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. |
| 24112371 | 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. |
| 22507444 | 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. |
| 25486644 | 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. |
| 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 |
| 29661237 | 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. |
| 31247557 | 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. |
| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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