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
About this trial
This is an interventional treatment trial for Stroke focused on measuring Gait Therapy
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.
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
NCT ID
NCT03171207
First Posted
May 24, 2017
Last Updated
May 30, 2017
Sponsor
Lite Run Inc.
Collaborators
Minneapolis Veterans Affairs Medical Center, TREAT
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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Evaluation of a Novel Gait Training Device to Support Body Weight
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