LifeWalker Upright Walker vs. Conventional Rollator Walker and Predicate Device

NCT02968277 | Completed Results

• 1 other identifier: STU00202634
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain

Outcome Measures

Primary Outcomes (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.

  One testing session

Secondary Outcomes (6)

• 10 Meter Walk Test

  One testing session

• Baseline Modified Falls Efficacy Scale (mFES) Score:

  Baseline score taken at first session

• Visual Analog Pain Scale (VAS)

  Baseline score taken at first session

• User Functional Rating Scale

  One testing session

• Borg Rate of Perceived Exertion

  One testing session

Study Arms (3)

Started with Forearm Support Walker (LW Upright)

EXPERIMENTAL

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

Device: LifeWalker Upright; Device: Predicate Device; Device: Standard Rollator

Standard Rollator Walker (Control)

EXPERIMENTAL

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; Device: Predicate Device; Device: Standard Rollator

Predicate Device (PD)

EXPERIMENTAL

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

Device: LifeWalker Upright; Device: Predicate Device; Device: Standard Rollator

Interventions

LifeWalker Upright DEVICE

LifeWalker (LW) upright walker

Predicate Device (PD); Standard Rollator Walker (Control); Started with Forearm Support Walker (LW Upright)

Predicate Device DEVICE

Individual's personal walker

Predicate Device (PD); Standard Rollator Walker (Control); Started with Forearm Support Walker (LW Upright)

Standard Rollator DEVICE

A control rollator device

Predicate Device (PD); Standard Rollator Walker (Control); Started with Forearm Support Walker (LW Upright)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 30367875 DERIVED

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

All assessments were done on level ground surfaces, all tests were done in controlled, clinical environment. Long term effects of using LifeWalker could not be determined in this study. The pathological demographic of the study sample was diverse.

Results Point of Contact

• Title: Arun Jayaraman, PT, PhD; Director of Max Nader Lab for Rehabilitation Technologies and Outcomes
• Organization: Rehabilitation Institute of Chicago

ajayaraman@ricres.org

3122386875

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: No washout period between different arms

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: November 18, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)