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LifeWalker Upright Walker vs. Conventional Rollator Walker and Predicate Device

Primary Purpose

Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LifeWalker Upright
Predicate Device
Standard Rollator
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Back Pain

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Rehabilitation Institute of Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Started with Forearm Support Walker (LW Upright)

Standard Rollator Walker (Control)

Predicate Device (PD)

Arm Description

Data collection began with participants using the LifeWalker Upright Walker then using the two remaining walkers in a randomized order

Data collection began with participants using a conventional standard rollator (SR) walker then using the two remaining walkers in a randomized order

Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order

Outcomes

Primary Outcome Measures

6 Minute Walk Test
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

10 Meter Walk Test
Time to walk 10 meters is measured to calculate gait speed.
Baseline Modified Falls Efficacy Scale (mFES) Score:
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.
Visual Analog Pain Scale (VAS)
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.
User Functional Rating Scale
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.").
Borg Rate of Perceived Exertion
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.
Forearm and Hand Grip
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.

Full Information

First Posted
October 25, 2016
Last Updated
August 15, 2019
Sponsor
Shirley Ryan AbilityLab
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1. Study Identification

Unique Protocol Identification Number
NCT02968277
Brief Title
LifeWalker Upright Walker vs. Conventional Rollator Walker and Predicate Device
Official Title
LifeWalker Upright Walker Versus Conventional Rollator Walker and Predicate Device
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
No washout period between different arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Started with Forearm Support Walker (LW Upright)
Arm Type
Experimental
Arm Description
Data collection began with participants using the LifeWalker Upright Walker then using the two remaining walkers in a randomized order
Arm Title
Standard Rollator Walker (Control)
Arm Type
Experimental
Arm Description
Data collection began with participants using a conventional standard rollator (SR) walker then using the two remaining walkers in a randomized order
Arm Title
Predicate Device (PD)
Arm Type
Experimental
Arm Description
Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order
Intervention Type
Device
Intervention Name(s)
LifeWalker Upright
Intervention Description
LifeWalker (LW) upright walker
Intervention Type
Device
Intervention Name(s)
Predicate Device
Intervention Description
Individual's personal walker
Intervention Type
Device
Intervention Name(s)
Standard Rollator
Intervention Description
A control rollator device
Primary Outcome Measure Information:
Title
6 Minute Walk Test
Description
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.
Time Frame
One testing session
Secondary Outcome Measure Information:
Title
10 Meter Walk Test
Description
Time to walk 10 meters is measured to calculate gait speed.
Time Frame
One testing session
Title
Baseline Modified Falls Efficacy Scale (mFES) Score:
Description
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.
Time Frame
Baseline score taken at first session
Title
Visual Analog Pain Scale (VAS)
Description
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.
Time Frame
Baseline score taken at first session
Title
User Functional Rating Scale
Description
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.").
Time Frame
One testing session
Title
Borg Rate of Perceived Exertion
Description
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.
Time Frame
One testing session
Title
Forearm and Hand Grip
Description
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.
Time Frame
One testing session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Facility Information:
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30367875
Citation
Jayaraman C, Mummidisetty CK, Loesch A, Kaur S, Hoppe-Ludwig S, Staat M, Jayaraman A. Postural and Metabolic Benefits of Using a Forearm Support Walker in Older Adults With Impairments. Arch Phys Med Rehabil. 2019 Apr;100(4):638-647. doi: 10.1016/j.apmr.2018.10.001. Epub 2018 Oct 24.
Results Reference
derived

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LifeWalker Upright Walker vs. Conventional Rollator Walker and Predicate Device

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