Development of a Collapsible Folding Manual Wheelchair

Wheelchair Users Clinical Trial

Official title:

Development of a Collapsible Folding Manual Wheelchair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283296
• Other study ID #: 02331, 0408063
• Secondary ID: H133S030016
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2006
• Last updated: December 23, 2014
• Start date: January 2004
• Est. completion date: April 2011

Study information

• Verified date: December 2014
• Source: VA Pittsburgh Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2011
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Wheelchair Users

Intervention

Device:
• Endeavor
Collapsible, forward folding manual wheelchair

Locations

Country	Name	City	State
United States	Human Engineering Research Laboratories	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Pittsburgh Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	immediately following course completion	No
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.	2 week in-home trial	No
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.	2 week in-home trial	No

External Links

•   Human Engineering Research Laboratories