Evaluation of a Novel Gait Training Device to Support Body Weight

Stroke Clinical Trial

Official title:

Evaluation of a Novel Gait Training Device Using a Pressurized Lower Body Suit to Support Body Weight

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03171207
• Other study ID #: 4698-A
• Status: Not yet recruiting
• Phase: N/A
• First received: May 24, 2017
• Last updated: May 30, 2017
• Start date: June 2017
• Est. completion date: September 2017

Study information

• Verified date: May 2017
• Source: Lite Run Inc.
• Contact: John Hauck, MSEE
• Phone: 651 336 7405
• Email: john[@]literun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Brain Injuries
• Brain Injuries, Traumatic
• Gait Disorders, Neurologic
• Nervous System Diseases
• Spinal Cord Injuries
• Stroke
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Lite Run Inc.	Minneapolis Veterans Affairs Medical Center, TREAT

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of therapists and/or aides required for a therapy session	Count of therapists and/or aides involved in therapy	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	Total cumulative time (min) for all therapists and aides involved in a therapy 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	Total time spent (min) by patient in an upright position	From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)
Secondary	Amount of unweighting	The amount of unweighting (pounds of body support) will be measured using a scale	Will be assessed during the first five minutes of each therapy session following fitting of harnessing system
Secondary	Numerical pain rating scale	Patient rating of pain (on a 0-10 numerical scale) will be assessed at the end of each therapy session	Will be assessed at the end of each therapy session (approximately 60 minutes)
Secondary	Patient Satisfaction	The first 8 questions of the Modified Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) will be given	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	The first 8 questions of the Modified Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) will be given	Will be assessed at the end of the study (i.e., after four therapy sessions lasting approximately 60 minutes each)