Cerebral Vascular Accident, Hemiparesis, Stroke, Stroke Hemorrhagic, Stroke, Ischemic
Conditions
Keywords
Keeogo™, Dermoskeleton, Powered dermoskeleton, Lower limb dermoskeleton, Assistive exoskeleton, Orthotic dermoskeleton
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.
Interventions
DEVICEKeeogo™ Dermoskeleton
This device is intended 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.
Sponsors
B-Temia, Inc.
Study design
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.
Intervention model description
Device: Keeogo™ Dermoskeleton This device is intended 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device-related adverse events [Safety] | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device malfunctions during study procedures [Device Reliability] | Duration of study completion for each site, estimated 3-5 weeks | Device reliability will be evaluated on the basis of the number of device malfunctions reported by research study staff for the duration of study procedures at each study site. |
| Incidence of injury to Physical Therapist (PT) caused by device [PT safety] | Duration of study completion for each site, estimated 3-5 weeks | PT safety will be evaluated on the basis of the number of serious device-related injuries reported by study physical therapists for the duration of study procedures at each study site. |
| Device, Effectiveness | Duration of study participation for each subject, estimated 3-5 weeks | Clinician and Patient Reported Outcomes (surveys) will be used to assess the effectiveness of the device in assisting gait. The surveys will rate subject performance in walking based on clinician observed deviations and subject perception of mobility limitation due to the stroke. * Device effectiveness will be measured based on statistical analysis of the survey data between conditions (baseline compared to device-use) Ratings by the surveys will be validated using instrumented walkway and image data collected during walking. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Timed Stair Test | Duration of study completion for each site, estimated 3-5 weeks | Subjects start with both feet on the bottom landing then ascend and descend a set number of stairs as quickly as possible in a safe manner using a rail only if needed. Time is recorded from ascent through descent. Patient and Clinician reported outcomes are assessed for this measure via a stair ascent/descent question on the survey given for the secondary effectiveness endpoint. |
| Patient and Clinician Reported Outcomes (surveys) | Duration of study completion for each site, estimated 3-5 weeks | Questionnaires provide patient and clinician-centric view of treatment of gait deficit. |
| 30-Second Chair Stand Test | Duration of study completion for each site, estimated 3-5 weeks | Subjects sit in the middle of chair and place hands on opposite shoulder crossed at wrists. Keeping feet flat on floor, back straight, arms against chest, subjects rise to full standing position when told go followed by sit down, the start position. This movement is repeated for as many times as possible for 30 seconds. Additionally, the test is repeated for a total of 5 cycles with short rest (≤ 90 seconds) between sets. Patient and Clinician reported outcomes are assessed for this measure via a sit-to-stand-to-sit question on the survey given for the secondary effectiveness endpoint. |
Countries
Canada, United States
Outcome results
None listed