Print

Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention 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
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VTS Static Use, then Dynamic Use (Aim 2) 		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)
    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.
Experimental
VTS Dynamic Use, then Static Use (Aim 2) 		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)
    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.
Other
VTS Neurophysiological Mechanism (Aim 1) 		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)
    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.

Recruiting Locations

Department of Rehabilitation Medicine
New York, New York 10065
Contact:
Joan Stilling, MD., MS.
212-746-1500
qsi9001@med.cornell.edu

More Details

Status
Recruiting
Sponsor
Weill Medical College of Cornell University

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.