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Implant for Walking After Stroke

Active Not RecruitingNA

Sponsor: MetroHealth Medical Center

Conditions: Stroke, Hemiplegia, Gait, Hemiplegic

Interventions: IRS-8, IST 12 & IST 16

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 21 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (2)

Cleveland, Ohio, United States
Cleveland, Ohio, United States