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

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ClinicalTrials.gov Identifier: NCT03986320
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Stroke Hemorrhagic Stroke Hemiparesis Cerebral Vascular Accident Device: Keeogo™ Dermoskeleton Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Masking Description: Sites will enroll participants in order of recruitment. No other randomization procedure will be applied.
Primary Purpose: Supportive Care
Official Title: 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.
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. 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 adverse events reported for subjects during their participation in the study.


Secondary Outcome Measures :
  1. Incidence of device malfunctions during study procedures [Device Reliability] [ Time Frame: 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.

  2. Incidence of injury to Physical Therapist (PT) caused by device [PT safety] [ Time Frame: Duration of study completion for each site, estimated 3-5 weeks ]
    PT safety will be evaluated on the basis of the number of device-related injuries reported by study physical therapists for the duration of study procedures at each study site.

  3. Device, Effectiveness [ Time Frame: 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 Outcome Measures:
  1. 30-Second Chair Stand Test [ Time Frame: 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.


  2. Timed Stair Test [ Time Frame: 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986320


Contacts
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Contact: David Castelo 514-267-4934 david.castelo@b-temia.com
Contact: Alexandre Jokic 418-653-1010 ext 248 alexandre.jokic@b-temia.com

Locations
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United States, Illinois
Shirley Ryan Ability Lab (SRA) Enrolling by invitation
Chicago, Illinois, United States, 60611
United States, New Jersey
Human Performance and Engineering Research (HPER)
West Orange, New Jersey, United States, 07052
United States, New York
James J Peters VA Medical Center - Center for the Medical Consequences of Spinal Cord Injury
Bronx, New York, United States, 10468
Canada, Ontario
Assistive Technology Clinic (ATC) Enrolling by invitation
Toronto, Ontario, Canada, M6A 2E1
Sponsors and Collaborators
B-Temia, Inc.
Investigators
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Principal Investigator: Arun Jayaraman, PT, PhD. Shirley Ryan Ability Lab (SRA)

Additional Information:
Publications:
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Responsible Party: B-Temia, Inc.
ClinicalTrials.gov Identifier: NCT03986320     History of Changes
Other Study ID Numbers: KEOG-SE-002
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by B-Temia, Inc.:
Keeogo™
Dermoskeleton
Powered dermoskeleton
Lower limb dermoskeleton
Assistive exoskeleton
Orthotic dermoskeleton

Additional relevant MeSH terms:
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Stroke
Ischemia
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms