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

Official title

Vibrotactile Stimulation for Lower Limb Spasticity

Overview

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.

Interventions

• Device 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
• Device 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
• Device 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 m

Primary outcome measures

• H-reflex amplitude Baseline (Aim 1) [Time frame: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1]
• H-reflex amplitude After Intervention (Aim 1) [Time frame: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1]
• Surface EMG activity of gastrocnemius/soleus Baseline (Aim 1) [Time frame: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1]
• Surface EMG activity of gastrocnemius/soleus After Intervention (Aim 1) [Time frame: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1]
• Modified Ashworth Scale at Screening [Time frame: Screening Visit (-0 to 7 days prior to Aim 1 intervention)]
• Modified Ashworth Scale at Baseline (Aim 1) [Time frame: Baseline measurement immediately before three 15-minutes intervention periods within a single session (Day 1) for Aim 1]
• Modified Ashworth Scale After Intervention (Aim 1) [Time frame: Immediately after each of three 15-minutes intervention periods within a single session (Day 1) for Aim 1]
• Modified Ashworth Scale at Baseline (Aim 2) [Time frame: Baseline measurement immediately before intervention for 3 consecutive days for Aim 2]
• Modified Ashworth Scale After Intervention (Aim 2) [Time frame: Immediately after intervention for 3 consecutive days for Aim 2]
• Passive range of motion at the ankle at Screening [Time frame: Screening Visit (-0 to 7 days prior to Aim 1 intervention)]

Secondary outcome measures (10)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Department of Rehabilitation Medicine — New York

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. PMID 30690609
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07447934 · 25-07029051 · UL1TR002384

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗