Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 11:22 PM
Study NCT ID:
NCT00392860
Status:
COMPLETED
Last Update Posted:
2014-02-21
First Post:
2006-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development of an Ergonomic Wheelchair Pushrim
Sponsor:
VA Pittsburgh Healthcare System
Organization:
Study Overview
Official Title:
Development of an Ergonomic Manual Wheelchair Pushrim- Phase II
Status:
COMPLETED
Status Verified Date:
2014-01
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 study is to test the effectiveness of newly designed ergonomic manual wheelchair handrims called the Natural-Fit and PalmRim when compared to a new standard handrim. It is our hope that the new design of the handrims will help reduce upper extremity pain and injury, which is very common among manual wheelchair users. The Natural-Fit handrim was designed to directly address the shortcomings of standard handrims and to improve the standard-round tube handrims which were designed over 50 years ago. The PalmRim was designed for individuals who have limited hand function, making it difficult to grasp standard handrims.
Detailed Description:
This research will have three parts.
The first part will include completing propulsion and braking tasks with the subject's original handrims. After the initial testing, new handrims (NaturalFit, PalmRim, and a new standard handrim) will be installed on the subject's wheelchair and subjects will again be asked to complete another set of propulsion and braking tasks. Subjects will also be asked to complete a questionnaire to assess wrist and shoulder pain and undergo an examination of the condition of the palm of their hand.
For the second part of the study, subjects will be asked to participate in a 4-month trial use period of the new handrims on their wheelchair.
In the third part of the study, subjects will complete the final set of propulsion and braking tasks and complete a follow-up questionnaire.
The first part will include completing propulsion and braking tasks with the subject's original handrims. After the initial testing, new handrims (NaturalFit, PalmRim, and a new standard handrim) will be installed on the subject's wheelchair and subjects will again be asked to complete another set of propulsion and braking tasks. Subjects will also be asked to complete a questionnaire to assess wrist and shoulder pain and undergo an examination of the condition of the palm of their hand.
For the second part of the study, subjects will be asked to participate in a 4-month trial use period of the new handrims on their wheelchair.
In the third part of the study, subjects will complete the final set of propulsion and braking tasks and complete a follow-up questionnaire.
Study Oversight
Has Oversight DMC:
False
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?: