Clinical trial NCT03171207: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Brain Injuries, Traumatic
Spinal Cord Injuries
Gait Disorders, Neurologic
Keywords: Gait Therapy
Lead sponsor: Lite Run Inc.
Sponsor class: INDUSTRY
Collaborators: name: Minneapolis Veterans Affairs Medical Center
name: TREAT
First posted: 2017-05-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of therapists and/or aides required for a therapy session
timeFrame: From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)
measure: Total therapist and/or aide time involved in a session
timeFrame: From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)
Secondary outcomes:
measure: Total time spent by patient in an upright position during a therapy session
timeFrame: From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)
measure: Amount of unweighting
timeFrame: Will be assessed during the first five minutes of each therapy session following fitting of harnessing system
measure: Numerical pain rating scale
timeFrame: Will be assessed at the end of each therapy session (approximately 60 minutes)
measure: Patient Satisfaction
timeFrame: Will be assessed after the last session in each study arm (i.e., after two therapy sessions lasting approximately 60 minutes each)
measure: Therapist Satisfaction
timeFrame: Will be assessed at the end of the study (i.e., after four therapy sessions lasting approximately 60 minutes each)
Other outcomes:
Locations:
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Sara R Koehler-McNicholas, PhD
role: PRINCIPAL_INVESTIGATOR
References: