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

Not Applicable

• Conditions: Stroke Hemorrhagic; Stroke; Cerebral Vascular Accident; Stroke, Ischemic; Hemiparesis
• Interventions: Device: Keeogo™ Dermoskeleton

• Registration Number: NCT03986320
• Lead Sponsor: B-Temia, Inc.

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 Timeline

• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-14
• Study Start: 2019-07-22
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-10-29
• Primary Completion: 2020-03
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Keeogo™ Dermoskeleton	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (4)

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; 🇺🇸 Bronx, New York, United States

Assistive Technology Clinic (ATC); 🇨🇦 Toronto, Ontario, Canada