- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00283296
Development of a Collapsible Folding Manual Wheelchair
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15206
- Human Engineering Research Laboratories
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Use a manual wheelchair as a primary means of mobility.
- Male and females over the age of 18.
- The ability to adequately fit in a wheelchair with a 16" seat width.
- A minimum of 6 months experience using a manual wheelchair as primary means of mobility.
- Able to transfer independently.
- Drive own vehicle from vehicle seat.
Exclusion Criteria:
- Active pressure sores as reported by subject.
- History of traumatic upper extremity injury that would prevent you from folding, lifting and storing a manual wheelchair.
Study Plan
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 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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Collapsible, forward folding manual wheelchair
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: immediately following course completion
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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.
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immediately following course completion
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Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c)
Time Frame: 2 week in-home trial
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Mean distance traveled per/day using the personal w/c was recorded with use of customized datalogger.
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2 week in-home trial
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Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c)
Time Frame: 2 week in-home trial
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Mean distance traveled per/day using the Endeavor w/c was recorded with use of customized datalogger.
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2 week in-home trial
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 02331, 0408063
- H133S030016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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