Customizable Cooperative Multi-joint Control to Enhance Walking Mobility After Stroke
MetroHealth Medical Center
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.
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 ses…
Eligibility
- Age range
- 21–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * At least 6-months post stroke * Age 21 to 75 years old * Able to ambulate, but does not require the assistance of more than one person * Walk slower than 0.8m/s during a 10m walk test * Lower extremity Fugl-Meyer Motor Assessment (FMA) \<= 20 * Reduced peak hip, knee and/or ankle range of motion during stance or swing phases * Modified Ashworth Scale (MAS) \<= 2 at the above joints during passive flexion and extension * Innervated and excitable lower extremity and trunk musculature * Appropriate body habitus (height and weight within acceptable limits as determined by st…
Interventions
- DeviceIRS-8
Implanted Receiver Stimulator (IRS) delivering 8 channels of stimulation. Appropriate for muscle-based (intramuscular or epimysial) electrodes only
- DeviceIST 12 & IST 16
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).
Locations (2)
- Louis Stokes Cleveland Veterans Affairs Medical CenterCleveland, Ohio
- MetroHealth Medical CenterCleveland, Ohio