Evaluation of a Novel Gait Training Device to Support Body Weight

NCT ID: NCT03171207

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2017-09-30

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.

Conditions

Stroke; Brain Injuries, Traumatic; Spinal Cord Injuries; Gait Disorders, Neurologic

Keywords

Gait Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Lite Run Gait Trainer

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Start with Current Harness System

Patients start therapy with a Current Harness System, followed by the Lite Run Gait Trainer in an ABAB design.

Group Type: EXPERIMENTAL

Lite Run Gait Trainer

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role: collaborator

TREAT

UNKNOWN

Sponsor Role: collaborator

Lite Run Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sara R Koehler-McNicholas, PhD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Veterans Affairs Medical Center

Central Contacts

John Hauck, MSEE

Role: CONTACT

Phone: 651 336 7405

Email: john@literun.com

Sara R Koehler-McNicholas, PhD

Role: CONTACT

Phone: 612 467 4017

Email: sara.koehler@va.gov

Other Identifiers

4698-A

Identifier Type: -

Identifier Source: org_study_id