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Evaluation of a Novel Gait Training Device to Support Body Weight

Primary Purpose

Stroke, Brain Injuries, Traumatic, Spinal Cord Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lite Run Gait Trainer
Current Harness System
Sponsored by
Lite Run Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Gait Therapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Veterans age: 18-90 years, male or female,
  • Who are receiving physical therapy as an inpatient at MVAHCS,
  • Have Functional Independence Measure (FIM) scores of 0 or 1 (out of 7) in at least one of the five domains of motor tasks: 1) bed, chair, and wheelchair transfers, 2) toilet transfers, 3) tub/shower transfers, 4) walk/wheelchair locomotion, 5) stair locomotion,
  • Who are determined by VA standards to require at least 35 pounds of physical support, such that 2 or more physical therapists and/or aides are needed during therapy, and
  • Are able to understand informed consent.

Exclusion Criteria:

  • Patients who have active clostridium difficile,
  • An acute diagnosis of deep vein thrombosis, chronic deep vein thrombosis, or phlebitis (unless cleared by clinician to participate in the study),
  • A lower body pressure ulcer worse than grade one (EPUAP), or an open wound,
  • A history of any drug-resistant pathogen, such as Methicillin-resistant Staphylococcus aureus (MRSA) or Vancomycin-resistant enterococci (VRE), ESBL producing gram-negative bacilli, or others,
  • Weigh more than 350 lbs.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Start with Lite Run Gait Trainer

    Start with Current Harness System

    Arm Description

    Patients start therapy with the Lite Run Gait Trainer device, followed by a Current Harness System in an ABAB design.

    Patients start therapy with a Current Harness System, followed by the Lite Run Gait Trainer in an ABAB design.

    Outcomes

    Primary Outcome Measures

    Number of therapists and/or aides required for a therapy session
    Count of therapists and/or aides involved in therapy
    Total therapist and/or aide time involved in a session
    Total cumulative time (min) for all therapists and aides involved in a therapy session

    Secondary Outcome Measures

    Total time spent by patient in an upright position during a therapy session
    Total time spent (min) by patient in an upright position
    Amount of unweighting
    The amount of unweighting (pounds of body support) will be measured using a scale
    Numerical pain rating scale
    Patient rating of pain (on a 0-10 numerical scale) will be assessed at the end of each therapy session
    Patient Satisfaction
    The first 8 questions of the Modified Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) will be given
    Therapist Satisfaction
    The first 8 questions of the Modified Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) will be given

    Full Information

    First Posted
    May 24, 2017
    Last Updated
    May 30, 2017
    Sponsor
    Lite Run Inc.
    Collaborators
    Minneapolis Veterans Affairs Medical Center, TREAT
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03171207
    Brief Title
    Evaluation of a Novel Gait Training Device to Support Body Weight
    Official Title
    Evaluation of a Novel Gait Training Device Using a Pressurized Lower Body Suit to Support Body Weight
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2017 (Anticipated)
    Primary Completion Date
    August 2017 (Anticipated)
    Study Completion Date
    September 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lite Run Inc.
    Collaborators
    Minneapolis Veterans Affairs Medical Center, TREAT

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A novel body weight support device that uses pressurized pants may provide advantages in delivering gait therapy. The objectives of this study are to test the following hypotheses that 1) the novel device will allow for increased body weight support while improving or maintaining the same level of patient comfort; 2) the novel device will yield greater patient satisfaction with gait therapy relative to current harness systems; 3) therapists will be more satisfied with the use of the novel device relative to current harness systems; 4) the use of the novel device will require less total therapist time than a harness comparator; 5) the use of the novel device will increase therapeutic treatment time when compared with current harness systems.
    Detailed Description
    This is a single group repeated measures ABAB design. The study will include four sessions for each participant, with two sessions conducted using a novel Lite Run Gait Trainer device (Lite Run, Inc., Minneapolis, MN) and two sessions conducted using the comparator method of choice by the physical therapist (harness system). The initial condition (harness or Lite Run) will be randomized. The overall gait training physical therapy session will follow standard of care; the only factor that will change will be the assistive device used during therapy (harness or Lite Run). Participants will include 10 VA inpatients receiving physical therapy at the Minneapolis VA Health Care System (MVAHCS). Patients will be recruited from three VA rehabilitation units: Physical Medicine and Rehabilitation (PM&R), Spinal Cord Injury and Disease (SCI/D) Center, and Community Living Center (CLC). Participants will have a range of diagnoses: stroke, traumatic brain injury, spinal cord injury, wounds, obesity. The number of therapists and their time involvement will be tracked as a primary outcome measure in this study. The effectiveness of treatment will also be assessed for both assistive device methods. The total amount of therapeutic treatment time will be measured as the time spent by the patient in an upright position. At the end of each therapy session, participants will also be asked to rate their pain (comfort), perceived level of exertion, and will fill out a questionnaire about their experience with the Lite Run Gait Trainer. The physical therapists involved in the study will also provide their feedback.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Brain Injuries, Traumatic, Spinal Cord Injuries, Gait Disorders, Neurologic
    Keywords
    Gait Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Start with Lite Run Gait Trainer
    Arm Type
    Experimental
    Arm Description
    Patients start therapy with the Lite Run Gait Trainer device, followed by a Current Harness System in an ABAB design.
    Arm Title
    Start with Current Harness System
    Arm Type
    Experimental
    Arm Description
    Patients start therapy with a Current Harness System, followed by the Lite Run Gait Trainer in an ABAB design.
    Intervention Type
    Device
    Intervention Name(s)
    Lite Run Gait Trainer
    Intervention Description
    The Lite Run Gait Trainer is a novel device with pneumatic pants that can be used to assist with body support assisted gait therapy.
    Intervention Type
    Device
    Intervention Name(s)
    Current Harness System
    Intervention Description
    There are a variety of harness systems (e.g., ceiling lift, Lite Gait) that are currently used to assist with body support assisted gait therapy.
    Primary Outcome Measure Information:
    Title
    Number of therapists and/or aides required for a therapy session
    Description
    Count of therapists and/or aides involved in therapy
    Time Frame
    From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)
    Title
    Total therapist and/or aide time involved in a session
    Description
    Total cumulative time (min) for all therapists and aides involved in a therapy session
    Time Frame
    From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)
    Secondary Outcome Measure Information:
    Title
    Total time spent by patient in an upright position during a therapy session
    Description
    Total time spent (min) by patient in an upright position
    Time Frame
    From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)
    Title
    Amount of unweighting
    Description
    The amount of unweighting (pounds of body support) will be measured using a scale
    Time Frame
    Will be assessed during the first five minutes of each therapy session following fitting of harnessing system
    Title
    Numerical pain rating scale
    Description
    Patient rating of pain (on a 0-10 numerical scale) will be assessed at the end of each therapy session
    Time Frame
    Will be assessed at the end of each therapy session (approximately 60 minutes)
    Title
    Patient Satisfaction
    Description
    The first 8 questions of the Modified Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) will be given
    Time Frame
    Will be assessed after the last session in each study arm (i.e., after two therapy sessions lasting approximately 60 minutes each)
    Title
    Therapist Satisfaction
    Description
    The first 8 questions of the Modified Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) will be given
    Time Frame
    Will be assessed at the end of the study (i.e., after four therapy sessions lasting approximately 60 minutes each)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Veterans age: 18-90 years, male or female, Who are receiving physical therapy as an inpatient at MVAHCS, Have Functional Independence Measure (FIM) scores of 0 or 1 (out of 7) in at least one of the five domains of motor tasks: 1) bed, chair, and wheelchair transfers, 2) toilet transfers, 3) tub/shower transfers, 4) walk/wheelchair locomotion, 5) stair locomotion, Who are determined by VA standards to require at least 35 pounds of physical support, such that 2 or more physical therapists and/or aides are needed during therapy, and Are able to understand informed consent. Exclusion Criteria: Patients who have active clostridium difficile, An acute diagnosis of deep vein thrombosis, chronic deep vein thrombosis, or phlebitis (unless cleared by clinician to participate in the study), A lower body pressure ulcer worse than grade one (EPUAP), or an open wound, A history of any drug-resistant pathogen, such as Methicillin-resistant Staphylococcus aureus (MRSA) or Vancomycin-resistant enterococci (VRE), ESBL producing gram-negative bacilli, or others, Weigh more than 350 lbs.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    John Hauck, MSEE
    Phone
    651 336 7405
    Email
    john@literun.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sara R Koehler-McNicholas, PhD
    Phone
    612 467 4017
    Email
    sara.koehler@va.gov
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sara R Koehler-McNicholas, PhD
    Organizational Affiliation
    Minneapolis Veterans Affairs Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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