Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
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 (\

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03986320). StuddyBuddy aggregates publicly available trial information.