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Clinical Trial Summary

This is a device study that will evaluate the effect of an implanted stimulator on improving walking in stroke survivors. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) Implantation, controller development, and evaluation - this phase includes installing the device and setting the individual up for home use, creating advanced controllers for walking and evaluating the effect of the device over several months.


Clinical Trial Description

The purpose of this study is to evaluate the effects of neural stimulation for improving walking after stroke. Participants will undergo surgery to implant a stimulator and electrodes to activate muscles used during walking. The device delivers electrical pulses to the nerves causing the muscles to contract to perform functional movements. The system coordinates assistance based on external sensors. After receiving the implanted device, participants undergo training to use the device to assist walking. Evaluations are completed prior to surgery as well after training and at later follow up sessions. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05740540
Study type Interventional
Source MetroHealth Medical Center
Contact Lisa Lombardo, MPT
Phone 216-791-3800
Email lisa.lombardo2@va.gov
Status Recruiting
Phase N/A
Start date May 16, 2023
Completion date March 31, 2027

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