Development of a Collapsible Folding Manual Wheelchair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by VA Pittsburgh Healthcare System.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
VA Pittsburgh Healthcare System
ClinicalTrials.gov Identifier:
NCT00283296
First received: January 24, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  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: Collapsible folding manual wheelchair
Phase 2

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

Resource links provided by NLM:


Further study details as provided by VA Pittsburgh Healthcare System:

Primary Outcome Measures:
  • Performance and ease of task ratings, response to questionnaires, wheelchair usage (i.e. speed, distance)

Estimated Enrollment: 25
Study Start Date: April 2006
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 a 10-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.

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

Contacts
Contact: Annmarie R Kelleher, MS, OTR/L 412-365-4850 kellehera@herlpitt.org
Contact: Emily Teodorski, BS 412-365-4850 teodorskie@herlpitt.org

Locations
United States, Pennsylvania
Human Engineering Research Laboratories Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15206
Principal Investigator: Rory A Cooper, PhD         
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

ClinicalTrials.gov Identifier: NCT00283296     History of Changes
Other Study ID Numbers: 02331, 0408063, H133S030016
Study First Received: January 24, 2006
Last Updated: January 24, 2006
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 September 18, 2014