A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the Keeogo™ Dermoskeleton in subjects with hemiparesis due to ischemic or hemorrhagic stroke.
Stroke affects thousands of individuals annually, leading to considerable physical impairment and functional disability. Gait is one of the most important activities of daily living affected in this patient population. Recent technological developments in passively powered dermoskeleton can create powerful adjunctive tools for rehabilitation and potentially accelerate functional recovery. Here, the investigators present the development and evaluation of a lower limb dermoskeleton, namely Keeogo™ (B-Temia), for use in rehabilitation institutions to assist individuals with hemiparesis due to stroke who are able to stand and initiate a step in performing ambulatory functions. Keeogo™ Dermoskeleton is a low-profile, assistive exoskeleton (or 'dermoskeleton') that orthotically fits to the lower limbs. Keeogo™ is worn on the user's lower body using a belt and contact areas attached around the thighs and calves.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
This device is intended for use in rehabilitation institutions to assist individuals with hemiparesis due to stroke who are able to stand and initiate a step in performing ambulatory functions.
Shirley Ryan Ability Lab (SRA)
Chicago, Illinois, United States
Human Performance and Engineering Research (HPER)
West Orange, New Jersey, United States
James J Peters VA Medical Center - Center for the Medical Consequences of Spinal Cord Injury
The Bronx, New York, United States
Assistive Technology Clinic (ATC)
Toronto, Ontario, Canada
Incidence of device-related adverse events [Safety]
Safety will be evaluated on the basis of the number of device-related serious adverse events reported for subjects during their participation in the study.
Time frame: Duration of study participation for each subject, estimated 3-5 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 3-5 weeks
Incidence of injury to Physical Therapist (PT) caused by device [PT safety]
PT safety will be evaluated on the basis of the number of serious 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 3-5 weeks
Device, Effectiveness
Clinician and Patient Reported Outcomes (surveys) will be used to assess the effectiveness of the device in assisting gait. The surveys will rate subject performance in walking based on clinician observed deviations and subject perception of mobility limitation due to the stroke. * Device effectiveness will be measured based on statistical analysis of the survey data between conditions (baseline compared to device-use) Ratings by the surveys will be validated using instrumented walkway and image data collected during walking.
Time frame: Duration of study participation for each subject, estimated 3-5 weeks
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