Clinical trial NCT02968277: 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
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2016-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: No washout period between different arms
Primary purpose: SUPPORTIVE_CARE

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.

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.)

Primary outcomes:
measure: 6 Minute Walk Test
timeFrame: One testing session
Secondary outcomes:
measure: 10 Meter Walk Test
timeFrame: One testing session
measure: Baseline Modified Falls Efficacy Scale (mFES) Score:
timeFrame: Baseline score taken at first session
measure: Visual Analog Pain Scale (VAS)
timeFrame: Baseline score taken at first session
measure: User Functional Rating Scale
timeFrame: One testing session
measure: Borg Rate of Perceived Exertion
timeFrame: One testing session
measure: Forearm and Hand Grip
timeFrame: One testing session
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
References:
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.