Gait, Hemiplegic, Hemiplegia, Stroke
Conditions
Brief 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.
Detailed 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.
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).
Sponsors
MetroHealth Medical Center
Case Western Reserve University
Louis Stokes VA Medical Center
Cleveland State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
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 study physician) * Adequate social support and stability * Willingness to comply with follow-up procedures * Neurologically stable as determined by a physician
Exclusion criteria
* Non-English speaking * Significant range of motion limitations (lacking hip extension, etc.) * History of spontaneous fractures or other evidence of excessively low bone density * Acute orthopedic problems (severe scoliosis, joint dislocations, etc.) * Medical complications (cardiac abnormalities, skin breakdowns, uncontrolled seizures, immunological/pulmonary/renal/circulatory compromise, additional neurologic conditions etc.) * Cardiovascular or pulmonary disease * Uncontrolled diabetes or hypertension * Presence of a demand pacemaker or cardiac defibrillator * Pregnancy * Complications of stroke that result in an increased risk of falls (apraxia, uncompensated hemineglect, hemianopsia etc.) * Significant history of repeated falls * Severely impaired cognition and communication * Any other medical or psychological condition that would be a contraindication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Gait speed | baseline, ~18 weeks post implant, ~44 week post implant | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Usability Rating Scale (URS) | baseline, ~18 weeks post implant, ~44-week post implant | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNathan Makowski, PhD
MetroHealth System, Ohio
Outcome results
None listed