Wheelchair Users
Conditions
Keywords
manual wheelchair, assistive technology, travel wheelchair
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEndeavor
Collapsible, forward folding manual wheelchair
Sponsors
VA Pittsburgh Healthcare System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Use a manual wheelchair as a primary means of mobility. 2. Male and females over the age of 18. 3. The ability to adequately fit in a wheelchair with a 16 seat width. 4. A minimum of 6 months experience using a manual wheelchair as primary means of mobility. 5. Able to transfer independently. 6. Drive own vehicle from vehicle seat.
Exclusion criteria
1. Active pressure sores as reported by subject. 2. History of traumatic upper extremity injury that would prevent you from folding, lifting and storing a manual wheelchair.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reported the Endeavor to be the Same as Their Current w/c or Better With Regards to Transporting in a Vehicle | immediately following course completion | 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. |
| Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c) | 2 week in-home trial | Mean distance traveled per/day using the personal w/c was recorded with use of customized datalogger. |
| Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c) | 2 week in-home trial | Mean distance traveled per/day using the Endeavor w/c was recorded with use of customized datalogger. |
Countries
United States
Participant flow
Recruitment details
All recruitment and data collection occured in 2008 at the Human Engineering Research Laboratories.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | in-home trial not completed | 5 |
Baseline characteristics
| Characteristic | Endeavor Wheelchair |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 45.2 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
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.
Time frame: 2 week in-home trial
Population: Endeavor w/c
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endeavor Wheelchair | Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c) | 1688 meters/day | Standard Deviation 822 |
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.
Time frame: 2 week in-home trial
Population: personal w/c
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endeavor Wheelchair | Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c) | 1726 meters/day | Standard Deviation 716 |
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.
Time frame: immediately following course completion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endeavor Wheelchair | Number of Participants Reported the Endeavor to be the Same as Their Current w/c or Better With Regards to Transporting in a Vehicle | 10 participants |