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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
6
Implanted Receiver Stimulator (IRS) delivering 8 channels of stimulation. Appropriate for muscle-based (intramuscular or epimysial) electrodes only
Implantable Stimulator Telemeter (IST) that provides 12 independent channels of stimulation with the option of 2 channels of bipolar myoelectric signal recording, or 16 independent stimulus channels. Suitable for muscle-based or nerve cuff electrodes such as the CWRU Spiral, Flat Interface Nerve Electrode (FINE) or Composite-Flat Interface Nerve Electrode (C-FINE).
Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohio, United States
RECRUITINGMetroHealth Medical Center
Cleveland, Ohio, United States
NOT_YET_RECRUITINGDifference in Gait speed
The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance. Gait speed is how we're evaluating whether the advanced controller works better than a simple generic triggering approach.
Time frame: baseline, ~18 weeks post implant, ~44 week post implant
Difference in Usability Rating Scale (URS)
participants will rate the task on a seven-point scale from "very easy" (3) to "very difficult" (-3). Difficulty will be assessed after the 10 m walk test
Time frame: baseline, ~18 weeks post implant, ~44-week post implant
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