Evaluation of a Novel Gait Training Device to Support Body Weight

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Lite Run Gait Trainer Device
    Intervention Desc: The Lite Run Gait Trainer is a novel device with pneumatic pants that can be used to assist with body support assisted gait therapy.
    ARM 1: Kind: Experimental
    Label: Start with Lite Run Gait Trainer
    Description: Patients start therapy with the Lite Run Gait Trainer device, followed by a Current Harness System in an ABAB design.
    ARM 2: Kind: Experimental
    Label: Start with Current Harness System
    Description: Patients start therapy with a Current Harness System, followed by the Lite Run Gait Trainer in an ABAB design.
  • Current Harness System Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Start with Lite Run Gait Trainer
    Description: Patients start therapy with the Lite Run Gait Trainer device, followed by a Current Harness System in an ABAB design.
    ARM 2: Kind: Experimental
    Label: Start with Current Harness System
    Description: Patients start therapy with a Current Harness System, followed by the Lite Run Gait Trainer in an ABAB design.

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of therapists and/or aides required for a therapy session From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)
Primary Total therapist and/or aide time involved in a session From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)
Secondary Total time spent by patient in an upright position during a therapy session From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)
Secondary Amount of unweighting Will be assessed during the first five minutes of each therapy session following fitting of harnessing system
Secondary Numerical pain rating scale Will be assessed at the end of each therapy session (approximately 60 minutes)
Secondary Patient Satisfaction Will be assessed after the last session in each study arm (i.e., after two therapy sessions lasting approximately 60 minutes each)
Secondary Therapist Satisfaction Will be assessed at the end of the study (i.e., after four therapy sessions lasting approximately 60 minutes each)

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