Vibrotactile Stimulation for Muscle Spasticity

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Must not be taking: Botulinum Toxin

Disqualifiers: Uncontrolled illness, Surgery, Unstable medications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

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

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?

Inclusion Criteria

I can understand and follow the study instructions.

It has been at least 6 months since my diagnosis that caused spasticity.

My ankle muscle tightness is moderate or less.

Exclusion Criteria

I have had Botulinum Toxin treatment in my affected limb within the last 4 months.

I do not have any serious or uncontrolled illnesses that could affect my participation.

I have had surgery to treat spasticity in my affected leg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

0 to 1 week

VTS Neurophysiological Mechanism

Participants use the VTS device for three 15-minute sessions at different anatomical locations to assess neurophysiological mechanisms.

1 day

1 visit (in-person)

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.

3 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vibrotactile Stimulation

How Is the Trial Designed?

Group I: VTS Static Use, then Dynamic Use (Aim 2) Experimental Treatment 1 Intervention

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.

Group II: VTS Neurophysiological Mechanism (Aim 1) Experimental Treatment 1 Intervention

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.

Group III: VTS Dynamic Use, then Static Use (Aim 2) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+