A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the ReWalk ReStore device in subjects with hemiplegia/hemiparesis due to ischemic or hemorrhagic stroke.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
40
The ReWalk ReStore device is intended to be used to perform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke.
Shirley Ryan AbilityLab
Chicago, Illinois, United States
Spaulding Rehabilitation Institute
Boston, Massachusetts, United States
Kessler Foundation
West Orange, New Jersey, United States
Moss Rehab
Elkins Park, Pennsylvania, United States
Incidence of device-related adverse events [Safety]
Safety will be evaluated on the basis of the number of device-related adverse events reported for subjects during their participation in the study.
Time frame: duration of study participation for each subject, estimated 4 weeks
Incidence of device malfunctions during study procedures [Device Reliability]
Device reliability will be evaluated on the basis of the number of device malfunctions reported by research study staff for the duration of study procedures at each study site.
Time frame: duration of study completion for each site, estimated 4 months
Incidence of injury to physical therapist caused by device [PT safety]
PT safety will be evaluated on the basis of the number of device-related injuries reported by study physical therapists for the duration of study procedures at each study site.
Time frame: duration of study completion for each site, estimated 4 months
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TIRR Memorial Hermann
Houston, Texas, United States