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Evaluation of a Novel Gait Training Device to Support Body Weight

NCT03171207 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-05-31

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Minneapolis Veterans Affairs Medical Center

    collaborator FED

  • TREAT

    collaborator UNKNOWN

  • Lite Run Inc.

    lead INDUSTRY

Principal Investigators

  • Sara R Koehler-McNicholas, PhD · Minneapolis Veterans Affairs Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2017-08-31
Completion
2017-09-30
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03171207 on ClinicalTrials.gov