Back Pain
Conditions
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.
Interventions
DEVICEStandard Rollator
A control rollator device
DEVICELifeWalker Upright
LifeWalker (LW) upright walker
DEVICEPredicate Device
Individual's personal walker
Sponsors
Shirley Ryan AbilityLab
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
No washout period between different arms
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 Minute Walk Test | One testing session | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Modified Falls Efficacy Scale (mFES) Score: | Baseline score taken at first session | 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. |
| Visual Analog Pain Scale (VAS) | Baseline score taken at first session | 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. |
| 10 Meter Walk Test | One testing session | Time to walk 10 meters is measured to calculate gait speed. |
| Borg Rate of Perceived Exertion | One testing session | 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. |
| Forearm and Hand Grip | One testing session | 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. |
| User Functional Rating Scale | One testing session | 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.). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| Started With Standard Rollator Walker Data collection began with participants using a conventional standard rollator (SR) walker then using the two remaining walkers in a randomized order | 7 |
| 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 | 13 |
| Total | 30 |
Baseline characteristics
| Characteristic | Started With Standard Rollator Walker | Started With Predicate Device (PD) | Total | Started With Forearm Support Walker (LW Upright) |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 6 Participants | 12 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 7 Participants | 18 Participants | 6 Participants |
| Age, Continuous | 61.9 years STANDARD_DEVIATION 11.3 | 61.9 years STANDARD_DEVIATION 8.4 | 62.9 years STANDARD_DEVIATION 8.9 | 64.8 years STANDARD_DEVIATION 8.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United States | 7 participants | 13 participants | 30 participants | 10 participants |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 24 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 6 Participants | 2 Participants |
| Use Walker for Ambulation | 7 Participants | 13 Participants | 30 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Time frame: One testing session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Forearm Support Walker (LW Upright) | 6 Minute Walk Test | 245.2 meters | Standard Error 19.1 |
| Standard Rollator Walker (Control) | 6 Minute Walk Test | 234.7 meters | Standard Error 18.8 |
| Predicate Device (PD) | 6 Minute Walk Test | 233.9 meters | Standard Error 17 |
Secondary
10 Meter Walk Test
Time to walk 10 meters is measured to calculate gait speed.
Time frame: One testing session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Forearm Support Walker (LW Upright) | 10 Meter Walk Test | 1.00 meters per second | Standard Error 0.06 |
| Standard Rollator Walker (Control) | 10 Meter Walk Test | 1.04 meters per second | Standard Error 0.07 |
| Predicate Device (PD) | 10 Meter Walk Test | 1.01 meters per second | Standard Error 0.06 |
Secondary
Baseline Modified Falls Efficacy Scale (mFES) Score:
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Forearm Support Walker (LW Upright) | Baseline Modified Falls Efficacy Scale (mFES) Score: | 8.20 score on a scale | Standard Deviation 1.6 |
| Standard Rollator Walker (Control) | Baseline Modified Falls Efficacy Scale (mFES) Score: | 7.47 score on a scale | Standard Deviation 0.94 |
| Predicate Device (PD) | Baseline Modified Falls Efficacy Scale (mFES) Score: | 6.19 score on a scale | Standard Deviation 2.1 |
Secondary
Borg Rate of Perceived Exertion
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Forearm Support Walker (LW Upright) | Borg Rate of Perceived Exertion | 12 score on a scale | Standard Error 0.57 |
| Standard Rollator Walker (Control) | Borg Rate of Perceived Exertion | 14.1 score on a scale | Standard Error 0.64 |
| Predicate Device (PD) | Borg Rate of Perceived Exertion | 14.1 score on a scale | Standard Error 0.62 |
Secondary
Forearm and Hand Grip
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Forearm Support Walker (LW Upright) | Forearm and Hand Grip | 4.8 kilograms | Standard Error 0.9 |
| Standard Rollator Walker (Control) | Forearm and Hand Grip | 5.8 kilograms | Standard Error 1.05 |
| Predicate Device (PD) | Forearm and Hand Grip | 5.7 kilograms | Standard Error 0.78 |
Secondary
User Functional Rating Scale
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Forearm Support Walker (LW Upright) | User Functional Rating Scale | 7.17 score on a scale | Standard Deviation 1.78 |
| Standard Rollator Walker (Control) | User Functional Rating Scale | 8.26 score on a scale | Standard Deviation 2.07 |
| Predicate Device (PD) | User Functional Rating Scale | 8.58 score on a scale | Standard Deviation 1.56 |
Secondary
Visual Analog Pain Scale (VAS)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Forearm Support Walker (LW Upright) | Visual Analog Pain Scale (VAS) | 4.48 score on a scale | Standard Deviation 2.4 |
| Standard Rollator Walker (Control) | Visual Analog Pain Scale (VAS) | 3.86 score on a scale | Standard Deviation 2.2 |
| Predicate Device (PD) | Visual Analog Pain Scale (VAS) | 2.77 score on a scale | Standard Deviation 2.2 |