Development of a Collapsible Folding Manual Wheelchair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rory Cooper, VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier:
NCT00283296
First received: January 24, 2006
Last updated: December 23, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention Phase
Wheelchair Users
Device: Endeavor
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Development of a Collapsible Folding Manual Wheelchair

Further study details as provided by VA Pittsburgh Healthcare System:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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) [ Time Frame: 2 week in-home trial ] [ Designated as safety issue: No ]
    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) [ Time Frame: 2 week in-home trial ] [ Designated as safety issue: No ]
    Mean distance traveled per/day using the Endeavor w/c was recorded with use of customized datalogger.


Enrollment: 14
Study Start Date: January 2004
Study Completion Date: April 2011
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Endeavor
Collapsible, forward folding manual wheelchair

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00283296

Locations
United States, Pennsylvania
Human Engineering Research Laboratories
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
VA Pittsburgh Healthcare System
Investigators
Principal Investigator: Rory A Cooper, PhD Human Engineering Research Laboratories
  More Information

Additional Information:
No publications provided

Responsible Party: Rory Cooper, Director; Pittsburgh VA Rehabilitation Research & Development Center, VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier: NCT00283296     History of Changes
Other Study ID Numbers: 02331, 0408063, H133S030016
Study First Received: January 24, 2006
Results First Received: June 11, 2013
Last Updated: December 23, 2014
Health Authority: United States: Federal Government

Keywords provided by VA Pittsburgh Healthcare System:
manual wheelchair
assistive technology
travel wheelchair

ClinicalTrials.gov processed this record on August 26, 2015