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| ID | Type | Description | Link |
|---|---|---|---|
| H133S030016 |
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The purpose of this research study is to evaluate the Endeavor, a compact, forward-folding, ultralight manual wheelchair that incorporates small "swing-down" wheels for navigation in confined areas. This enables access to narrow environments such as those encountered in offices, restrooms, and transportation settings. When using the small access wheels, the wheelchair also fits down the aisle of airplanes and collapses to be stowed in the overhead compartment. It is anticipated that the Endeavor will maximize mobility; increase access to confined areas; and ease the demands of travel for people with disabilities.
The purpose of this research study is to evaluate the Endeavor, a compact, forward-folding, ultralight manual wheelchair that incorporates small "swing-down" wheels for navigation in confined areas. This enables access to narrow environments such as those encountered in offices, restrooms, and transportation settings. When using the small access wheels, the wheelchair also fits down the aisle of airplanes and collapses to be stowed in the overhead compartment. It is anticipated that the Endeavor will maximize mobility; increase access to confined areas; and ease the demands of travel for people with disabilities.
There are two stages to this research project: an Activities of Daily Living Course and an In-Home trial. The activities of daily living course is located at the Human Engineering Research Laboratories and simulates daily barriers encountered by wheelchair users. Subjects will be asked to complete the course in their personal wheelchair and in the Endeavor three times each. Testing will be completed during a one-day visit that will not exceed 2 1/2 hours.
For the in-home trial, subjects will be asked to use the Endeavor as their primary means of mobility for two weeks, which will be compared to using their own wheelchair for two weeks. During this four-week period a datalogger will be mounted to the subject's wheelchair(s), which will give information about distance traveled, average speed, and time used. In addition to the data-logger, subjects will also be asked to keep a brief, daily, written log of the activities they performed while in the chair. At the end of the Endeavor trial-use period, subjects will be asked to complete a questionnaire. There is an 8-week follow-up period where subjects will be allowed to keep the Endeavor. We will make three calls during this period to conduct interviews on usage of the Endeavor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endeavor Wheelchair | Experimental | Participants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endeavor | Device | Collapsible, forward folding manual wheelchair |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reported the Endeavor to be the Same as Their Current w/c or Better With Regards to Transporting in a Vehicle | Participants completed an Activities of Daily Living Course in their own personal w/c and the Endeavor. Then participants were asked to rate their level of difficulty to complete based on a 5 point likert scale: very difficult, difficult, moderate, easy, very easy. Number of participants reported the Endeavor w/c to be the same as their current w/c or better with regards to transporting in a vehicle. | immediately following course completion |
| Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c) | Mean distance traveled per/day using the personal w/c was recorded with use of customized datalogger. | 2 week in-home trial |
| Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c) | Mean distance traveled per/day using the Endeavor w/c was recorded with use of customized datalogger. | 2 week in-home trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rory A Cooper, PhD | Human Engineering Research Laboratories | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Engineering Research Laboratories | Pittsburgh | Pennsylvania | 15206 | United States |
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All recruitment and data collection occured in 2008 at the Human Engineering Research Laboratories.
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| ID | Title | Description |
|---|---|---|
| FG000 | Endeavor Wheelchair | All participants completed the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair three times each. Testing was completed during a one-day visit that did not exceed 2 1/2 hours. For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Endeavor Wheelchair | Participants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reported the Endeavor to be the Same as Their Current w/c or Better With Regards to Transporting in a Vehicle | Participants completed an Activities of Daily Living Course in their own personal w/c and the Endeavor. Then participants were asked to rate their level of difficulty to complete based on a 5 point likert scale: very difficult, difficult, moderate, easy, very easy. Number of participants reported the Endeavor w/c to be the same as their current w/c or better with regards to transporting in a vehicle. | Posted | Number | participants | immediately following course completion |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Endeavor Wheelchair | Participants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ankle/foot injury | Musculoskeletal and connective tissue disorders | Participant bruised right foot/ankle while using the Endeavor w/c. |
Limited number of Endeavor prototypes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rory Cooper, PhD | Human Engineering Research Laboratories | 412-822-3700 | rcooper@pitt.edu |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
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| Participants |
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| Primary | Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c) | Mean distance traveled per/day using the personal w/c was recorded with use of customized datalogger. | personal w/c | Posted | Mean | Standard Deviation | meters/day | 2 week in-home trial |
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| Primary | Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c) | Mean distance traveled per/day using the Endeavor w/c was recorded with use of customized datalogger. | Endeavor w/c | Posted | Mean | Standard Deviation | meters/day | 2 week in-home trial |
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| 14 |
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| 14 |
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