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LifeWalker Upright Walker vs. Conventional Rollator Walker and Predicate Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02968277
Recruitment Status : Completed
First Posted : November 18, 2016
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Back Pain
Interventions Device: LifeWalker Upright
Device: Predicate Device
Device: Standard Rollator
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Started With Forearm Support Walker (LW Upright) Started With Standard Rollator Walker Started With Predicate Device (PD)
Hide Arm/Group Description Data collection began with participants using the LifeWalker Upright walker then the other two walkers in a randomized order Data collection began with participants using a conventional standard rollator (SR) walker then the other two 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
Period Title: Overall Study
Started 10 7 13
Completed 10 7 13
Not Completed 0 0 0
Arm/Group Title Started With Forearm Support Walker (LW Upright) Started With Standard Rollator Walker Started With Predicate Device (PD) Total
Hide Arm/Group 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 Total of all reporting groups
Overall Number of Baseline Participants 10 7 13 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 7 participants 13 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  60.0%
5
  71.4%
7
  53.8%
18
  60.0%
>=65 years
4
  40.0%
2
  28.6%
6
  46.2%
12
  40.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 7 participants 13 participants 30 participants
64.8  (8.2) 61.9  (11.3) 61.9  (8.4) 62.9  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 7 participants 13 participants 30 participants
Female
8
  80.0%
6
  85.7%
10
  76.9%
24
  80.0%
Male
2
  20.0%
1
  14.3%
3
  23.1%
6
  20.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 7 participants 13 participants 30 participants
10 7 13 30
Use Walker for Ambulation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 7 participants 13 participants 30 participants
10
 100.0%
7
 100.0%
13
 100.0%
30
 100.0%
1.Primary Outcome
Title 6 Minute Walk Test
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Forearm Support Walker (LW Upright) Standard Rollator Walker (Control) Predicate Device (PD)
Hide Arm/Group Description:
Data collected while participants used the LifeWalker Upright walker.
Data collected while participants used a conventional standard rollator (SR) walker.
Data collected while participants used their own rollator walkers.
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Error)
Unit of Measure: meters
245.2  (19.1) 234.7  (18.8) 233.9  (17.0)
2.Secondary Outcome
Title 10 Meter Walk Test
Hide Description Time to walk 10 meters is measured to calculate gait speed.
Time Frame One testing session
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Forearm Support Walker (LW Upright) Standard Rollator Walker (Control) Predicate Device (PD)
Hide Arm/Group Description:
Data collected while participants used the LifeWalker Upright walker.
Data collected while participants used a conventional standard rollator (SR) walker.
Data collected while participants used their own rollator walkers.
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Error)
Unit of Measure: meters per second
1.00  (0.06) 1.04  (0.07) 1.01  (0.06)
3.Secondary Outcome
Title Baseline Modified Falls Efficacy Scale (mFES) Score:
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Started With Forearm Support Walker (LW Upright) Started With Standard Rollator Walker Started With Predicate Device (PD)
Hide Arm/Group 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
Overall Number of Participants Analyzed 10 7 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.20  (1.6) 7.47  (0.94) 6.19  (2.1)
4.Secondary Outcome
Title Visual Analog Pain Scale (VAS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Started With Forearm Support Walker (LW Upright) Started With Standard Rollator Walker Started With Predicate Device (PD)
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 7 13
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.48  (2.4) 3.86  (2.2) 2.77  (2.2)
5.Secondary Outcome
Title User Functional Rating Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Forearm Support Walker (LW Upright) Standard Rollator Walker (Control) Predicate Device (PD)
Hide Arm/Group Description:
Data collected while participants used the LifeWalker Upright walker.
Data collected while participants used a conventional standard rollator (SR) walker.
Data collected while participants used their own rollator walkers.
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.17  (1.78) 8.26  (2.07) 8.58  (1.56)
6.Secondary Outcome
Title Borg Rate of Perceived Exertion
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Forearm Support Walker (LW Upright) Standard Rollator Walker (Control) Predicate Device (PD)
Hide Arm/Group Description:
Data collected while participants used the LifeWalker Upright walker.
Data collected while participants used a conventional standard rollator (SR) walker.
Data collected while participants used their own rollator walkers.
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Error)
Unit of Measure: score on a scale
12  (0.57) 14.1  (0.64) 14.1  (0.62)
7.Secondary Outcome
Title Forearm and Hand Grip
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Forearm Support Walker (LW Upright) Standard Rollator Walker (Control) Predicate Device (PD)
Hide Arm/Group Description:
Data collected while participants used the LifeWalker Upright walker.
Data collected while participants used a conventional standard rollator (SR) walker.
Data collected while participants used their own rollator walkers.
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Error)
Unit of Measure: kilograms
4.8  (0.9) 5.8  (1.05) 5.7  (0.78)
Time Frame Adverse events were monitored/assessed, during every data collection session, through study completion, an average of 2 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Forearm Support Walker (LW Upright) Standard Rollator (Control) Predicate Device (PD)
Hide Arm/Group Description This arm reflects time during which participants were using the LifeWalker Upright walker This arm reflects time during which participants were using a standard rollator walker This arm reflects time during which participants were using their own rollator walkers
All-Cause Mortality
Forearm Support Walker (LW Upright) Standard Rollator (Control) Predicate Device (PD)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%)   0/30 (0.00%) 
Hide Serious Adverse Events
Forearm Support Walker (LW Upright) Standard Rollator (Control) Predicate Device (PD)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Forearm Support Walker (LW Upright) Standard Rollator (Control) Predicate Device (PD)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%)   0/30 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Arun Jayaraman, PT, PhD; Director of Max Nader Lab for Rehabilitation Technologies and Outcomes
Organization: Rehabilitation Institute of Chicago
Phone: 3122386875
EMail: ajayaraman@ricres.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT02968277    
Other Study ID Numbers: STU00202634
First Submitted: October 25, 2016
First Posted: November 18, 2016
Results First Submitted: May 22, 2019
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019