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OpenTrials
Completed

NCT Number: NCT00283296

Development of a Collapsible Folding Manual Wheelchair

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Human Engineering Research Laboratories

Pittsburgh, Pennsylvania, 15206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endeavor

Device

Collapsible, forward folding manual wheelchair

Primary outcomes

  1. 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

    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.

  2. Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c)

    Time frame: 2 week in-home trial

    Mean distance traveled per/day using the personal w/c was recorded with use of customized datalogger.

  3. Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c)

    Time frame: 2 week in-home trial

    Mean distance traveled per/day using the Endeavor w/c was recorded with use of customized datalogger.

Sponsors and collaborators

Lead sponsor

VA Pittsburgh Healthcare System

Fed

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2011
First posted
Jan 27, 2006
Registry last updated
Jan 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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