Evaluation of a Novel Gait Training Device to Support Body Weight

NCT03171207 | Unknown FDA Device

• 1 other identifier: 4698-A
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Gait Therapy

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• 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)

• Amount of unweighting

  Will be assessed during the first five minutes of each therapy session following fitting of harnessing system

• Numerical pain rating scale

  Will be assessed at the end of each therapy session (approximately 60 minutes)

• Patient Satisfaction

  Will be assessed after the last session in each study arm (i.e., after two therapy sessions lasting approximately 60 minutes each)

• Therapist Satisfaction

  Will be assessed at the end of the study (i.e., after four therapy sessions lasting approximately 60 minutes each)

Study Arms (2)

Start with Lite Run Gait Trainer

EXPERIMENTAL

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; Device: Current Harness System

Start with Current Harness System

EXPERIMENTAL

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

Device: Lite Run Gait Trainer; Device: Current Harness System

Interventions

Lite Run Gait Trainer 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.

Start with Current Harness System; Start with Lite Run Gait Trainer

Current Harness System 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; Start with Lite Run Gait Trainer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lite Run Inc.: lead
• Minneapolis Veterans Affairs Medical Center: collaborator
• TREAT: collaborator

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sara R Koehler-McNicholas, PhD

  Minneapolis Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Hauck, MSEE

CONTACT

651 336 7405; john@literun.com

Sara R Koehler-McNicholas, PhD

CONTACT

612 467 4017; sara.koehler@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 31, 2017
• Study Start: June 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 31, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share