NCT00283296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

January 6, 2015

Completed
Last Updated

January 6, 2015

Status Verified

December 1, 2014

Enrollment Period

4.5 years

First QC Date

January 24, 2006

Results QC Date

June 11, 2013

Last Update Submit

December 23, 2014

Conditions

Wheelchair Users

Keywords

manual wheelchairassistive technologytravel wheelchair

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

Endeavor Wheelchair

EXPERIMENTAL

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

Interventions

EndeavorDEVICE

Collapsible, forward folding manual wheelchair

Endeavor Wheelchair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Use a manual wheelchair as a primary means of mobility.
  • Male and females over the age of 18.
  • The ability to adequately fit in a wheelchair with a 16" seat width.
  • A minimum of 6 months experience using a manual wheelchair as primary means of mobility.
  • Able to transfer independently.
  • Drive own vehicle from vehicle seat.

You may not qualify if:

  • Active pressure sores as reported by subject.
  • History of traumatic upper extremity injury that would prevent you from folding, lifting and storing a manual wheelchair.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Engineering Research Laboratories

Pittsburgh, Pennsylvania, 15206, United States

Location

Limitations and Caveats

Limited number of Endeavor prototypes.

Results Point of Contact

Title
Rory Cooper, PhD
Organization
Human Engineering Research Laboratories
rcooper@pitt.edu
412-822-3700

Study Officials

  • Rory A Cooper, PhD

    Human Engineering Research Laboratories

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director; Pittsburgh VA Rehabilitation Research & Development Center

Study Record Dates

First Submitted

January 24, 2006

First Posted

January 27, 2006

Study Start

January 1, 2004

Primary Completion

July 1, 2008

Study Completion

April 1, 2011

Last Updated

January 6, 2015

Results First Posted

January 6, 2015

Record last verified: 2014-12

Locations

US(1)