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LifeWalker Upright Walker vs. Conventional Rollator Walker and Predicate Device

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ClinicalTrials.gov Identifier: NCT02968277
Recruitment Status : Completed
First Posted : November 18, 2016
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab

Brief Summary:
The purpose of this project is to evaluate if the LifeWalker Upright walker is improves walking and reports of pain compared to a conventional rollator and predicate walker device.

Condition or disease Intervention/treatment Phase
Back Pain Device: LifeWalker Upright Device: Predicate Device Device: Standard Rollator Not Applicable

Detailed Description:

The LifeWalker Upright is a walker that has been designed to address fall risk, slouching, and user confidence and comfort. The LifeWalker has adjustable armrests and handles that enable users to stand tall and look ahead, providing support and stability that is designed differently than conventional walkers. The LifeWalker Upright's design allows the user to walk within the walker. This allows people to walk inside the walker as opposed to behind the walker.

The purpose of this project is to evaluate if the LifeWalker Upright walker is improves walking and reports of pain compared to a conventional rollator and predicate walker device

Aim 1: Perform in-laboratory training on the Life Walker and testing to compare functional gait outcomes with the Life Walker compared to a conventional rollator and predicate assistive mobility device. We expect that participants will be able to walk longer and will perform more efficiently on measures of gait function when using the Life Walker.

Aim 2: Perform in-laboratory testing to compare self-reported pain with the Life Walker compared to a conventional rollator and predicate assistive mobility device. We expect that participants will report less pain because they will have a more efficient and upright posture when using Life Walker.

Aim 3: Perform in-laboratory testing to compare measures of quality of life with the Life Walker compared to a conventional rollator and predicate mobility device. We expect that participants will report better outcomes on quality of life measures because they will experience better self-esteem due to better mobility when using Life Walker.

Participants will first complete a series of gait testing. Gait testing will include the six minute walk test and the 10 meter walk test. In addition there will be hand and forearm load and grip testing using load sensors. Participants will also be asked to be videotaped during their training sessions. After all the testing is complete, participants will be asked to complete a set of self-report questionnaires. During each device session, participant heart rate, blood pressure and blood oxygenation will be measured. All of these procedures will be repeated with each device.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: No washout period between different arms
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: LifeWalker Upright Walker Versus Conventional Rollator Walker and Predicate Device
Study Start Date : June 2016
Actual Primary Completion Date : April 2019
Actual Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: Started with Forearm Support Walker (LW Upright)
Data collection began with participants using the LifeWalker Upright Walker then using the two remaining walkers in a randomized order
Device: LifeWalker Upright
LifeWalker (LW) upright walker

Device: Predicate Device
Individual's personal walker

Device: Standard Rollator
A control rollator device

Experimental: Standard Rollator Walker (Control)
Data collection began with participants using a conventional standard rollator (SR) walker then using the two remaining walkers in a randomized order
Device: LifeWalker Upright
LifeWalker (LW) upright walker

Device: Predicate Device
Individual's personal walker

Device: Standard Rollator
A control rollator device

Experimental: Predicate Device (PD)
Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order
Device: LifeWalker Upright
LifeWalker (LW) upright walker

Device: Predicate Device
Individual's personal walker

Device: Standard Rollator
A control rollator device




Primary Outcome Measures :
  1. 6 Minute Walk Test [ Time Frame: One testing session ]
    The 6 minute walk test is performed as an objective evaluation of functional exercise capacity. The 6minute walk test is easy to administer, well tolerated, and typically reflective of activities of daily living. The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. The number of stops and stumbles will be recorded during the test. This test will be administered while wearing a mask to measure oxygen consumption in addition to blood pressure, heart rate and oxygen saturation.


Secondary Outcome Measures :
  1. 10 Meter Walk Test [ Time Frame: One testing session ]
    Time to walk 10 meters is measured to calculate gait speed.

  2. Baseline Modified Falls Efficacy Scale (mFES) Score: [ Time Frame: Baseline score taken at first session ]
    The mFES is self-report questionnaire consisting of 14 items which is designed to measure fear of falling in the elderly. It assesses an individual's perception of balance during activities of daily living by asking "how confident are you that you can do the following activities without falling." Subjects answer questions about how confident they are in safely completing various tasks on a scale from 0 to 10, with 10 indicating greater confidence. The score below is the average item-score for the assessment.

  3. Visual Analog Pain Scale (VAS) [ Time Frame: Baseline score taken at first session ]
    The Visual Analog Scale Pain Scale is a measure of perceived pain intensity. It consists of a horizontal line that is 10 centimeters long. On either side of the line is a description of pain- to the left the description will read "No pain," and to the right the description will read "worst pain imaginable." The individual is instructed to mark a point on the continuum which represents his/her pain.

  4. User Functional Rating Scale [ Time Frame: One testing session ]
    Is specifically to assess the user's perception of difficulty in performing the functional tasks when using the different assistive devices. The scale is similar to the patient specific functional scale wherein functional tasks are rated in level of their difficulty from "0" ("inability to perform the task") to "10" ("no difficulty in performing the task.").

  5. Borg Rate of Perceived Exertion [ Time Frame: One testing session ]
    The Borg Rate of Perceived Exertion is a scale that measures perceived exertion during activity. The minimum score is 6 and the maximum score is 20, with higher values on the scale indicative of higher perceived exertion while completing an activity.

  6. Forearm and Hand Grip [ Time Frame: One testing session ]
    Specialty gloves and load cells will be used to measure to amount of load participants are using when using each device on the hands and also on the forearm. This will be collected during the six-minute walk test.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals who use a walker due to back pain or adults (over 18) who use a walker for ambulation.
  • Ages from 18 to 89 years old
  • Medically stable for therapy

Exclusion Criteria:

  • Patient weight exceeds 300 lbs
  • Patient height is below 5'0" or exceeds 6'3"
  • Inactive, physically unfit to fit into the device.
  • Cognitive deficits or visual impairment that would impair their ability to give informed consent or to follow simple instructions during the experiments.
  • Mini-Mental State Exam (MMSE) score below 17
  • Pregnant women
  • Co-morbidity that interferes with the study (e.g. stroke, pace maker placement, severe ischemia cardiac disease, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968277


Locations
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United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Shirley Ryan AbilityLab
  Study Documents (Full-Text)

Documents provided by Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab:
Study Protocol  [PDF] March 9, 2018
No Statistical Analysis Plan (SAP) exists for this study.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arun Jayaraman, PT, PhD, Principal Investigator, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT02968277    
Other Study ID Numbers: STU00202634
First Posted: November 18, 2016    Key Record Dates
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations