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出境医 / 临床实验 / Evaluation of the Effectiveness and Safety of Keeogo™ Dermoskeleton in Subjects With Mobility Impairments Due to Stroke

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

Study Description
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.

Study Design
Layout table for study information
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
Arms and Interventions
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.

Outcome Measures
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 serious 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 serious 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.


  3. Patient and Clinician Reported Outcomes (surveys) [ Time Frame: Duration of study completion for each site, estimated 3-5 weeks ]
    Questionnaires provide patient and clinician-centric view of treatment of gait deficit.


Eligibility Criteria
Layout table for eligibility information
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;
Contacts and Locations

Locations
Layout table for location information
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
Sponsors and Collaborators
B-Temia, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Arun Jayaraman, PT, PhD. Shirley Ryan Ability Lab (SRA)
Tracking Information
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
 (submitted: October 25, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2019)
  • 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.
  • 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 serious device-related injuries reported by study physical therapists for the duration of study procedures at each study site.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: October 25, 2019)
  • 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.
  • 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.
  • Patient and Clinician Reported Outcomes (surveys) [ Time Frame: Duration of study completion for each site, estimated 3-5 weeks ]
    Questionnaires provide patient and clinician-centric view of treatment of gait deficit.
Original Other Pre-specified Outcome Measures
 (submitted: June 13, 2019)
  • 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.
  • 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.
 
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.

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
Condition  ICMJE
  • Stroke, Ischemic
  • Stroke Hemorrhagic
  • Stroke
  • Hemiparesis
  • Cerebral Vascular Accident
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.
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
Publications *
  • Buesing C, Fisch G, O'Donnell M, Shahidi I, Thomas L, Mummidisetty CK, Williams KJ, Takahashi H, Rymer WZ, Jayaraman A. Effects of a wearable exoskeleton stride management assist system (SMA®) on spatiotemporal gait characteristics in individuals after stroke: a randomized controlled trial. J Neuroeng Rehabil. 2015 Aug 20;12:69. doi: 10.1186/s12984-015-0062-0.
  • Xu J, Murphy SL, Kochanek KD, Bastian B, Arias E. Deaths: Final Data for 2016. Natl Vital Stat Rep. 2018 Jul;67(5):1-76.
  • He Y, Eguren D, Luu TP, Contreras-Vidal JL. Risk management and regulations for lower limb medical exoskeletons: a review. Med Devices (Auckl). 2017 May 9;10:89-107. doi: 10.2147/MDER.S107134. eCollection 2017. Review.
  • Lee SH, Lee HJ, Chang WH, Choi BO, Lee J, Kim J, Ryu GH, Kim YH. Gait performance and foot pressure distribution during wearable robot-assisted gait in elderly adults. J Neuroeng Rehabil. 2017 Nov 28;14(1):123. doi: 10.1186/s12984-017-0333-z.
  • Morawietz C, Moffat F. Effects of locomotor training after incomplete spinal cord injury: a systematic review. Arch Phys Med Rehabil. 2013 Nov;94(11):2297-308. doi: 10.1016/j.apmr.2013.06.023. Epub 2013 Jul 9. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 13, 2019)
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:

  • 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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party B-Temia, Inc.
Study Sponsor  ICMJE B-Temia, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arun Jayaraman, PT, PhD. Shirley Ryan Ability Lab (SRA)
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