Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:11 PM
Study NCT ID:
NCT07447934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Test the Effectiveness of Vibrotactile Stimulation for Lower Limb Spasticity
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
Vibrotactile Stimulation for Lower Limb Spasticity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
* 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UL1TR002384 | NIH | None | https://reporter.nih.gov/quic… | View |