Clinical trial NCT00283296: Development of a Collapsible Folding Manual Wheelchair
Official title: Development of a Collapsible Folding Manual Wheelchair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Wheelchair Users
Keywords: manual wheelchair
assistive technology
travel wheelchair
Lead sponsor: VA Pittsburgh Healthcare System
Sponsor class: FED
First posted: 2006-01-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.

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 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.

Primary outcomes:
measure: Number of Participants Reported the Endeavor to be the Same as Their Current w/c or Better With Regards to Transporting in a Vehicle
timeFrame: immediately following course completion
measure: Average Distance Traveled Per/Day During the 2 Week Time Period (Personal w/c)
timeFrame: 2 week in-home trial
measure: Average Distance Traveled Per/Day During the 2 Week Time Period (Endeavor w/c)
timeFrame: 2 week in-home trial
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Human Engineering Research Laboratories
state: Pennsylvania
Study officials:
affiliation: Human Engineering Research Laboratories
name: Rory A Cooper, PhD
role: PRINCIPAL_INVESTIGATOR
References: