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

This is an interventional supportive care trial for Stroke, Ischemic focused on measuring Keeogo™, Dermoskeleton, Powered dermoskeleton, Lower limb dermoskeleton, Assistive exoskeleton, Orthotic dermoskeleton Read More

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 (<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;