LifeWalker Upright Walker vs. Conventional Rollator Walker and Predicate Device

NCT ID: NCT02968277

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-04-30

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.

Conditions

Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

LifeWalker Upright

Intervention Type: DEVICE

LifeWalker (LW) upright walker

Predicate Device

Intervention Type: DEVICE

Individual's personal walker

Standard Rollator

Intervention Type: DEVICE

A control rollator device

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

Group Type: EXPERIMENTAL

LifeWalker Upright

Intervention Type: DEVICE

LifeWalker (LW) upright walker

Predicate Device

Intervention Type: DEVICE

Individual's personal walker

Standard Rollator

Intervention Type: DEVICE

A control rollator device

Predicate Device (PD)

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

Group Type: EXPERIMENTAL

LifeWalker Upright

Intervention Type: DEVICE

LifeWalker (LW) upright walker

Predicate Device

Intervention Type: DEVICE

Individual's personal walker

Standard Rollator

Intervention Type: DEVICE

A control rollator device

Interventions

LifeWalker Upright

LifeWalker (LW) upright walker

Intervention Type: DEVICE

Predicate Device

Individual's personal walker

Intervention Type: DEVICE

Standard Rollator

A control rollator device

Intervention Type: 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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Arun Jayaraman, PT, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30367875 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

STU00202634

Identifier Type: -

Identifier Source: org_study_id