Development of a Collapsible Folding Manual Wheelchair

NCT ID: NCT00283296

Last Updated: 2015-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2011-04-30

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.

Conditions

Wheelchair Users

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Endeavor

Intervention Type: DEVICE

Collapsible, forward folding manual wheelchair

Interventions

Endeavor

Collapsible, forward folding manual wheelchair

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Pittsburgh Healthcare System

FED

Sponsor Role: lead

Responsible Party

Rory Cooper

Director; Pittsburgh VA Rehabilitation Research & Development Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rory A Cooper, PhD

Role: PRINCIPAL_INVESTIGATOR

Human Engineering Research Laboratories

Locations

Human Engineering Research Laboratories

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

H133S030016

Identifier Type: -

Identifier Source: secondary_id

02331, 0408063

Identifier Type: -

Identifier Source: org_study_id