Evaluation of the Effectiveness and Safety of Keeogo™ Dermoskeleton in Subjects With Mobility Impairments Due to Stroke

Status unconfirmed · Not applicable

Conditions studied: Stroke, Ischemic, Stroke Hemorrhagic, Stroke, Hemiparesis, Cerebral Vascular Accident

In brief

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.

Key facts

Study ID

NCT03986320

Run by

B-Temia, Inc.

People needed

60

Starts

2019-07-22

Expected to finish

2020-09-01

Last updated by the study team

2019-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 (<6 mo) lower-body hospitalizations or active treatments due to a joint, muscle, bone, nerve or vascular injury or condition
• Scheduled for major surgery within next 4 months
• Lower-extremity amputation above or below the knee
• Have uncontrolled hypertension
• Recent (<1 year) heart attack
• Have uncontrolled diabetes
• Diagnosed with other health condition(s) that affect mobility and balance; chronic obstructive pulmonary disease; peripheral arterial disease; vestibular disorders; cerebellar disease; cerebral palsy; muscular dystrophy spinal cord injury; other brain injury aside from the reported CVA;

Where it is running

• 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

Full record on ClinicalTrials.gov

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