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

B-Temia

Status

Unknown

Conditions

Cerebral Vascular Accident

Stroke

Stroke Hemorrhagic

Hemiparesis

Stroke, Ischemic

Treatments

Device: Keeogo™ Dermoskeleton

Study type

Interventional

Funder types

Industry

Identifiers

NCT03986320

KEOG-SE-002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;