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

October 25, 2019 updated by: B-Temia, Inc.

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6A 2E1
        • Assistive Technology Clinic (ATC)
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Shirley Ryan Ability Lab (SRA)
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Human Performance and Engineering Research (HPER)
    • New York
      • Bronx, New York, United States, 10468
        • James J Peters VA Medical Center - Center for the Medical Consequences of Spinal Cord Injury

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Duration of study participation for each subject, estimated 3-5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Duration of study completion for each site, estimated 3-5 weeks
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.
Duration of study completion for each site, estimated 3-5 weeks
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.
Duration of study participation for each subject, estimated 3-5 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Duration of study completion for each site, estimated 3-5 weeks
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.
Duration of study completion for each site, estimated 3-5 weeks
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.
Duration of study completion for each site, estimated 3-5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B-Temia, Inc.

Investigators

  • Principal Investigator: Arun Jayaraman, PT, PhD., Shirley Ryan Ability Lab (SRA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2019

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

June 6, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (Actual)

June 14, 2019

Study Record Updates

Last Update Posted (Actual)

October 29, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEOG-SE-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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