Trial Outcomes & Findings for LifeWalker Upright Walker vs. Conventional Rollator Walker and Predicate Device (NCT NCT02968277)
NCT ID: NCT02968277
Last Updated: 2019-09-06
Results Overview
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.
COMPLETED
NA
30 participants
One testing session
2019-09-06
Participant Flow
Participant milestones
| Measure |
Started With Forearm Support Walker (LW Upright)
Data collection began with participants using the LifeWalker Upright walker then the other two walkers in a randomized order
|
Started With Standard Rollator Walker
Data collection began with participants using a conventional standard rollator (SR) walker then the other two walkers in a randomized order
|
Started With Predicate Device (PD)
Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
7
|
13
|
|
Overall Study
COMPLETED
|
10
|
7
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Started With Forearm Support Walker (LW Upright)
n=10 Participants
Data collection began with participants using the LifeWalker Upright Walker then using the two remaining walkers in a randomized order
|
Started With Standard Rollator Walker
n=7 Participants
Data collection began with participants using a conventional standard rollator (SR) walker then using the two remaining walkers in a randomized order
|
Started With Predicate Device (PD)
n=13 Participants
Data collection began with participants using their own rollator walkers then using the two remaining walkers in a randomized order
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=10 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=13 Participants
|
18 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=10 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=13 Participants
|
12 Participants
n=30 Participants
|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 8.2 • n=10 Participants
|
61.9 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
61.9 years
STANDARD_DEVIATION 8.4 • n=13 Participants
|
62.9 years
STANDARD_DEVIATION 8.9 • n=30 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=10 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=13 Participants
|
24 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=10 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=13 Participants
|
6 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
7 participants
n=7 Participants
|
13 participants
n=13 Participants
|
30 participants
n=30 Participants
|
|
Use Walker for Ambulation
|
10 Participants
n=10 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=13 Participants
|
30 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: One testing sessionThe 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.
Outcome measures
| Measure |
Forearm Support Walker (LW Upright)
n=30 Participants
Data collected while participants used the LifeWalker Upright walker.
|
Standard Rollator Walker (Control)
n=30 Participants
Data collected while participants used a conventional standard rollator (SR) walker.
|
Predicate Device (PD)
n=30 Participants
Data collected while participants used their own rollator walkers.
|
|---|---|---|---|
|
6 Minute Walk Test
|
245.2 meters
Standard Error 19.1
|
234.7 meters
Standard Error 18.8
|
233.9 meters
Standard Error 17.0
|
SECONDARY outcome
Timeframe: One testing sessionTime to walk 10 meters is measured to calculate gait speed.
Outcome measures
| Measure |
Forearm Support Walker (LW Upright)
n=30 Participants
Data collected while participants used the LifeWalker Upright walker.
|
Standard Rollator Walker (Control)
n=30 Participants
Data collected while participants used a conventional standard rollator (SR) walker.
|
Predicate Device (PD)
n=30 Participants
Data collected while participants used their own rollator walkers.
|
|---|---|---|---|
|
10 Meter Walk Test
|
1.00 meters per second
Standard Error 0.06
|
1.04 meters per second
Standard Error 0.07
|
1.01 meters per second
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Baseline score taken at first sessionThe 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.
Outcome measures
| Measure |
Forearm Support Walker (LW Upright)
n=10 Participants
Data collected while participants used the LifeWalker Upright walker.
|
Standard Rollator Walker (Control)
n=7 Participants
Data collected while participants used a conventional standard rollator (SR) walker.
|
Predicate Device (PD)
n=13 Participants
Data collected while participants used their own rollator walkers.
|
|---|---|---|---|
|
Baseline Modified Falls Efficacy Scale (mFES) Score:
|
8.20 score on a scale
Standard Deviation 1.6
|
7.47 score on a scale
Standard Deviation 0.94
|
6.19 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline score taken at first sessionThe 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.
Outcome measures
| Measure |
Forearm Support Walker (LW Upright)
n=10 Participants
Data collected while participants used the LifeWalker Upright walker.
|
Standard Rollator Walker (Control)
n=7 Participants
Data collected while participants used a conventional standard rollator (SR) walker.
|
Predicate Device (PD)
n=13 Participants
Data collected while participants used their own rollator walkers.
|
|---|---|---|---|
|
Visual Analog Pain Scale (VAS)
|
4.48 score on a scale
Standard Deviation 2.4
|
3.86 score on a scale
Standard Deviation 2.2
|
2.77 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: One testing sessionIs 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.").
Outcome measures
| Measure |
Forearm Support Walker (LW Upright)
n=30 Participants
Data collected while participants used the LifeWalker Upright walker.
|
Standard Rollator Walker (Control)
n=30 Participants
Data collected while participants used a conventional standard rollator (SR) walker.
|
Predicate Device (PD)
n=30 Participants
Data collected while participants used their own rollator walkers.
|
|---|---|---|---|
|
User Functional Rating Scale
|
7.17 score on a scale
Standard Deviation 1.78
|
8.26 score on a scale
Standard Deviation 2.07
|
8.58 score on a scale
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: One testing sessionThe 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.
Outcome measures
| Measure |
Forearm Support Walker (LW Upright)
n=30 Participants
Data collected while participants used the LifeWalker Upright walker.
|
Standard Rollator Walker (Control)
n=30 Participants
Data collected while participants used a conventional standard rollator (SR) walker.
|
Predicate Device (PD)
n=30 Participants
Data collected while participants used their own rollator walkers.
|
|---|---|---|---|
|
Borg Rate of Perceived Exertion
|
12 score on a scale
Standard Error 0.57
|
14.1 score on a scale
Standard Error 0.64
|
14.1 score on a scale
Standard Error 0.62
|
SECONDARY outcome
Timeframe: One testing sessionSpecialty 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.
Outcome measures
| Measure |
Forearm Support Walker (LW Upright)
n=30 Participants
Data collected while participants used the LifeWalker Upright walker.
|
Standard Rollator Walker (Control)
n=30 Participants
Data collected while participants used a conventional standard rollator (SR) walker.
|
Predicate Device (PD)
n=30 Participants
Data collected while participants used their own rollator walkers.
|
|---|---|---|---|
|
Forearm and Hand Grip
|
4.8 kilograms
Standard Error 0.9
|
5.8 kilograms
Standard Error 1.05
|
5.7 kilograms
Standard Error 0.78
|
Adverse Events
Forearm Support Walker (LW Upright)
Standard Rollator (Control)
Predicate Device (PD)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Arun Jayaraman, PT, PhD; Director of Max Nader Lab for Rehabilitation Technologies and Outcomes
Rehabilitation Institute of Chicago
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place