A Multi-site, Interventional, Comparative, Single-arm Trial to Evaluate the Safety and Effectiveness of Keeogo™ Dermoskeleton in Subjects With Hemiparesis Due to Ischemic or Hemorrhagic Stroke.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- B-Temia, Inc.
- Enrollment
- 60
- Locations
- 8
- Primary Endpoint
- Incidence of device-related adverse events [Safety]
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
Sites will enroll participants in order of recruitment. No other randomization procedure will be applied.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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;
Arms & Interventions
Keeogo™ Dermoskeleton
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.
Intervention: Keeogo™ Dermoskeleton (Device)
Outcomes
Primary Outcomes
Incidence of device-related adverse events [Safety]
Time Frame: Duration of study participation for each subject, estimated 3-5 weeks
Safety will be evaluated on the basis of the number of device-related serious adverse events reported for subjects during their participation in the study.
Secondary Outcomes
- Incidence of device malfunctions during study procedures [Device Reliability](Duration of study completion for each site, estimated 3-5 weeks)
- Device, Effectiveness(Duration of study participation for each subject, estimated 3-5 weeks)
- Incidence of injury to Physical Therapist (PT) caused by device [PT safety](Duration of study completion for each site, estimated 3-5 weeks)