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Back PainNCT02968277

LifeWalker Upright Walker vs. Conventional Rollator Walker and Predicate Device

A study testing LifeWalker Upright, Predicate Device and Standard Rollator in people with Back Pain, run by Shirley Ryan AbilityLab at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Back Pain
What is being tested?
LifeWalker Upright, Predicate Device and Standard Rollator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Jun 2016to Apr 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rehabilitation Institute of Chicago

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: LifeWalker Upright Walker Versus Conventional Rollator Walker and Predicate Device

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.

Read the 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.

Conditions
Back Pain
Being tested
LifeWalker Upright, Predicate Device, Standard Rollator
Medical subject headings
Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LifeWalker UprightDevice

    LifeWalker (LW) upright walker

  • Predicate DeviceDevice

    Individual's personal walker

  • Standard RollatorDevice

    A control rollator device

Study groups in NCT02968277
Study groupRoleWhat they receive
Started with Forearm Support Walker (LW Upright)ExperimentalData collection began with participants using the LifeWalker Upright Walker then using the two remaining walkers in a randomized order
Receives: Device: LifeWalker Upright; Device: Predicate Device; Device: Standard Rollator
Standard Rollator Walker (Control)ExperimentalData collection began with participants using a conventional standard rollator (SR) walker then using the two remaining walkers in a randomized order
Receives: Device: LifeWalker Upright; Device: Predicate Device; Device: Standard Rollator
Predicate Device (PD)ExperimentalData collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order
Receives: Device: LifeWalker Upright; Device: Predicate Device; Device: Standard Rollator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: One testing session

Secondary outcomes (6)

  1. 10 Meter Walk Test

    Time to walk 10 meters is measured to calculate gait speed.

    Measured: One testing session

  2. 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.

    Measured: Baseline score taken at first session

  3. 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.

    Measured: Baseline score taken at first session

  4. 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.").

    Measured: One testing session

  5. 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.

    Measured: One testing session

  6. 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.

    Measured: One testing session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionApr 2019
  4. Study completionApr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
No washout period between different arms
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02968277
Sponsor's protocol ID
STU00202634
Status last verified
Aug 2019
First submitted
25 Oct 2016
Last updated
6 Sep 2019
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30367875

Questions about this trial

What is this clinical trial studying?

A study testing LifeWalker Upright, Predicate Device and Standard Rollator in people with Back Pain, run by Shirley Ryan AbilityLab at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 Minute Walk Test (time frame: One testing session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02968277, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019; AzTrials last refreshed its copy on 2 Nov 2026.

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