Vibrotactile Stimulation for Muscle Spasticity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether Vibrotactile Stimulation (VTS), a device that gently vibrates, can help individuals with lower limb spasticity (muscle stiffness) improve mobility and increase walking speed. Researchers aim to identify the optimal body locations for VTS application and determine its effectiveness in easing walking. Participants will use the VTS device during short sessions both at rest and while walking, and they will track their experiences. This trial may suit individuals who have experienced muscle stiffness for at least six months due to a neurological condition and can stand with or without assistance. As an unphased trial, it offers a unique opportunity to contribute to pioneering research that could enhance mobility solutions for many.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but if you are on medications for muscle relaxation, your regimen should be stable. If you are receiving other treatments like physiotherapy, they should have started more than 4 weeks before the trial and remain consistent.
What prior data suggests that this device is safe for use in people with lower limb spasticity?
Research has shown that Vibrotactile Stimulation (VTS) is generally safe and easy to use. Studies have found that short-term use of VTS with wearable devices does not cause harm and feels comfortable. No reports of serious side effects or health problems from VTS have emerged. This makes it a safe choice for those looking to reduce muscle stiffness and improve movement. However, users should monitor for any personal discomfort or issues while using the device.12345
Why are researchers excited about this trial?
Researchers are excited about vibrotactile stimulation (VTS) for muscle spasticity because it offers a non-invasive approach that could provide immediate relief. While most treatments for muscle spasticity, like oral medications or injections, often come with side effects or require time to take effect, VTS uses gentle vibrations to target specific muscles and might show benefits within days. This technique could be especially promising for improving mobility and comfort without the drawbacks of traditional therapies. Additionally, VTS's potential to be used both during rest and active movement offers flexible treatment options tailored to individual needs.
What evidence suggests that Vibrotactile Stimulation is effective for reducing muscle spasticity?
Research has shown that Vibrotactile Stimulation (VTS) can greatly reduce muscle stiffness. Studies have found that VTS relieves stiffness and high muscle tone for many people, even those who have tried other treatments like BTX-A. This type of stimulation decreases unwanted muscle spasms in various conditions. For example, VTS effectively reduces neck pain in people with cervical dystonia, a condition that causes neck muscle spasms. Overall, VTS shows promise for improving movement and reducing stiffness, making it a potential option for managing muscle stiffness. Participants in this trial will experience different applications of VTS, including static and dynamic use, to further explore its effectiveness.13467
Who Is on the Research Team?
Joan Stilling, M.D., M.S.
Principal Investigator
Weill Medical College of Cornell University
Are You a Good Fit for This Trial?
This trial is for adults with muscle stiffness in the leg due to a neurological condition (like stroke) that started at least 6 months ago. Participants must be able to stand or lie down, have moderate spasticity, and be able to follow study instructions. Recent botox treatment, surgery for spasticity, or unstable health conditions will exclude participation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
VTS Neurophysiological Mechanism
Participants use the VTS device for three 15-minute sessions at different anatomical locations to assess neurophysiological mechanisms.
VTS Static and Dynamic Use
Participants use the VTS device for 60 minutes daily for three consecutive days in static and dynamic contexts, with a 1-week washout period between.
Follow-up
Participants are monitored for safety and effectiveness after treatment.
What Are the Treatments Tested in This Trial?
Interventions
- Vibrotactile Stimulation
Trial Overview
The study tests different ways of using a vibrotactile stimulation (VTS) device on various body parts to see if it can reduce leg muscle stiffness and improve walking speed. Participants use the VTS device during lab sessions and at home while resting or walking.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Citations
Daily Vibrotactile Stimulation Exhibits Equal or Greater ...
Daily stimulation from the VTS Glove provides relief of spasticity and hypertonia. For more than half of the participants who had regularly used BTX-A, the VTS ...
Daily vibrotactile stimulation from a wearable device exhibits ...
Conclusions: Daily stimulation from the VTS Glove provides relief of spasticity and hypertonia. For more than half of participants who had ...
Trial to Test the Effectiveness of Vibrotactile Stimulation for ...
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 ...
4.
frontiersin.org
frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2023.1206027/fullRelief of post-stroke spasticity with acute vibrotactile ...
Cutaneous vibrotactile stimulation of the hand provides significant reductions in spastic hypertonia, compared to muscle stimulation.
Relief of post-stroke spasticity with acute vibrotactile stimulation
Cutaneous vibrotactile stimulation of the hand provides significant reductions in spastic hypertonia, compared to muscle stimulation.
Daily Vibrotactile Stimulation Exhibits Equal or Greater ...
The VTS Glove was associated with greater average improvement in spasticity and hypertonia than Botox injection.
Vibrotactile Stimulation for Muscle Spasticity
The goal of this clinical trial is to find out if Vibrotactile Stimulation (VTS) can help improve mobility and reduce spasticity (muscle ...
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