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Evaluation of a Novel Gait Training Device to Support Body Weight

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ClinicalTrials.gov Identifier: NCT03171207
Recruitment Status : Not yet recruiting
First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Collaborators:
Minneapolis Veterans Affairs Medical Center
TREAT
Information provided by (Responsible Party):
Lite Run Inc.

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.

Condition or disease Intervention/treatment Phase
Stroke Brain Injuries, Traumatic Spinal Cord Injuries Gait Disorders, Neurologic Device: Lite Run Gait Trainer Device: Current Harness System Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Novel Gait Training Device Using a Pressurized Lower Body Suit to Support Body Weight
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Start with Lite Run Gait Trainer
Patients start therapy with the Lite Run Gait Trainer device, followed by a Current Harness System in an ABAB design.
Device: Lite Run Gait Trainer
The Lite Run Gait Trainer is a novel device with pneumatic pants that can be used to assist with body support assisted gait therapy.

Device: Current Harness System
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.

Experimental: Start with Current Harness System
Patients start therapy with a Current Harness System, followed by the Lite Run Gait Trainer in an ABAB design.
Device: Lite Run Gait Trainer
The Lite Run Gait Trainer is a novel device with pneumatic pants that can be used to assist with body support assisted gait therapy.

Device: Current Harness System
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 Measures :
  1. Number of therapists and/or aides required for a therapy session [ Time Frame: From beginning of each therapy session to the end of each therapy session (approximately 60 minutes) ]
    Count of therapists and/or aides involved in therapy

  2. Total therapist and/or aide time involved in a session [ Time Frame: From beginning of each therapy session to the end of each therapy session (approximately 60 minutes) ]
    Total cumulative time (min) for all therapists and aides involved in a therapy session


Secondary Outcome Measures :
  1. Total time spent by patient in an upright position during a therapy session [ Time Frame: From beginning of each therapy session to the end of each therapy session (approximately 60 minutes) ]
    Total time spent (min) by patient in an upright position

  2. Amount of unweighting [ Time Frame: Will be assessed during the first five minutes of each therapy session following fitting of harnessing system ]
    The amount of unweighting (pounds of body support) will be measured using a scale

  3. Numerical pain rating scale [ Time Frame: Will be assessed at the end of each therapy session (approximately 60 minutes) ]
    Patient rating of pain (on a 0-10 numerical scale) will be assessed at the end of each therapy session

  4. Patient Satisfaction [ Time Frame: Will be assessed after the last session in each study arm (i.e., after two therapy sessions lasting approximately 60 minutes each) ]
    The first 8 questions of the Modified Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) will be given

  5. Therapist Satisfaction [ Time Frame: Will be assessed at the end of the study (i.e., after four therapy sessions lasting approximately 60 minutes each) ]
    The first 8 questions of the Modified Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) will be given



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171207


Contacts
Contact: John Hauck, MSEE 651 336 7405 john@literun.com
Contact: Sara R Koehler-McNicholas, PhD 612 467 4017 sara.koehler@va.gov

Sponsors and Collaborators
Lite Run Inc.
Minneapolis Veterans Affairs Medical Center
TREAT
Investigators
Principal Investigator: Sara R Koehler-McNicholas, PhD Minneapolis VA Health Care System

Responsible Party: Lite Run Inc.
ClinicalTrials.gov Identifier: NCT03171207     History of Changes
Other Study ID Numbers: 4698-A
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Lite Run Inc.:
Gait Therapy

Additional relevant MeSH terms:
Gait Disorders, Neurologic
Wounds and Injuries
Brain Injuries
Spinal Cord Injuries
Body Weight
Brain Injuries, Traumatic
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Spinal Cord Diseases
Signs and Symptoms
Neurologic Manifestations