Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283296
Status:
COMPLETED
Last Update Posted:
2015-01-06
First Post:
2006-01-24
Brief Title:
Development of a Collapsible Folding Manual Wheelchair
Sponsor:
VA Pittsburgh Healthcare System
Organization:
VA Pittsburgh Healthcare System
Study Overview
Official Title:
Development of a Collapsible Folding Manual Wheelchair
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 12 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 subjects wheelchairs 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
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 12 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 subjects wheelchairs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H133S030016 | None | None | None |