Condition or disease | Intervention/treatment | Phase |
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Stroke, Ischemic Stroke Hemorrhagic Stroke Hemiparesis Cerebral Vascular Accident | Device: Keeogo™ Dermoskeleton | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
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. |
Actual Study Start Date : | July 22, 2019 |
Estimated Primary Completion Date : | March 2020 |
Estimated Study Completion Date : | September 2020 |
Arm | Intervention/treatment |
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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.
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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.
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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.
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.
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be eligible to participate in this study, an individual must meet all of the following criteria:
Capable of standing and walking independently for an extended period of time (MMT
Presence of any gait deficit, as defined by one or more of the following clinical observations:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
United States, Illinois | |
Shirley Ryan Ability Lab (SRA) | |
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) | |
Toronto, Ontario, Canada, M6A 2E1 |
Principal Investigator: | Arun Jayaraman, PT, PhD. | Shirley Ryan Ability Lab (SRA) |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 6, 2019 | ||||||||
First Posted Date ICMJE | June 14, 2019 | ||||||||
Last Update Posted Date | October 29, 2019 | ||||||||
Actual Study Start Date ICMJE | July 22, 2019 | ||||||||
Estimated Primary Completion Date | March 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
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.
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||||||
Brief Title ICMJE | Evaluation of the Effectiveness and Safety of Keeogo™ Dermoskeleton in Subjects With Mobility Impairments Due to Stroke | ||||||||
Official Title ICMJE | 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. | ||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A 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
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Condition ICMJE |
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Intervention ICMJE | 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.
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Study Arms ICMJE | 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.
Intervention: Device: Keeogo™ Dermoskeleton
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Enrolling by invitation | ||||||||
Estimated Enrollment ICMJE |
60 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | September 2020 | ||||||||
Estimated Primary Completion Date | March 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria: To be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Listed Location Countries ICMJE | Canada, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03986320 | ||||||||
Other Study ID Numbers ICMJE | KEOG-SE-002 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | B-Temia, Inc. | ||||||||
Study Sponsor ICMJE | B-Temia, Inc. | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | B-Temia, Inc. | ||||||||
Verification Date | October 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |