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Completed
NCT03986320
Evaluation of the Effectiveness and Safety of Keeogo™ Dermoskeleton in Subjects With Mobility Impairments Due to Stroke
Conditions: Stroke, Ischemic, Stroke Hemorrhagic, Stroke, Hemiparesis, Cerebral Vascular Accident
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: B-Temia, Inc.
Location: Shirley Ryan Ability Lab (SRA) Chicago Illinois
Summary
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.
Eligibility Criteria
Inclusion Criteria:
To be eligible to participate in this study, an individual must meet all of the following criteria:
* Provide signed and dated informed consent form;
* Willing to comply with all study procedures and be available for the duration of the study \[2-3 days per week, 3-5 consecutive weeks\];
* Adults 18 years of age and older;
* Confirmed Cerebrovascular Accident (CVA) with hemiparesis;
* Stable stroke (≥ 6 months post-incident)
* Sufficient cognition to follow simple instructions and understand the content and purpose of the study (MMSE \> 20);
* Capable of standing and walking independently for an extended period of time (MMT
* 3 hip flexors and extensors, and ≥ 2 knee flexors and extensors with BBS ≥ 45);
* Presence of any gait deficit, as defined by one or more of the following clinical observations:
* Hip hike
* Hip circumduction
* Knee spasticity (MAS 2 to 3) as per Modified Ashworth Scale (MAS)
* Mid-foot striking (aka 'flat foot landing')
* Poor foot clearance (toe/foot drop or foot drag)
* Narrow steps (\< 1 shoe-width or \< 8 cm)
* Manual Muscle Test (MMT) of 4/5 for the unaffected upper extremity;
* Able to sit on a bench for more than 5 minutes;
* Is physically and mentally compatible with device to demonstrate ability to safely activate the Keeogo™ user interface;
* Able to understand and follow instructions with assistance if needed.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
* Legally blind
* Pregnant, lactating, or postpartum sacroiliac joint recovery is ongoing (recent childbirth, not yet cleared for vigorous exercise)
* Skin condition that contraindicates use of orthotics or support braces
* Recent (\
Source: ClinicalTrials.gov (NCT03986320). StuddyBuddy aggregates publicly available trial information.