Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281463
Status:
COMPLETED
Last Update Posted:
2014-11-18
First Post:
2006-01-23
Brief Title:
Impact of Pushrim Activated Power Assist Wheelchairs on Mobility Among People With Tetraplegia
Sponsor:
VA Pittsburgh Healthcare System
Organization:
VA Pittsburgh Healthcare System
Study Overview
Official Title:
Impact of Pushrim Activated Power Assist Wheelchairs on Mobility Among People With Tetraplegia
Status:
COMPLETED
Status Verified Date:
2014-11
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 three phase study is to evaluate a Pushrim Activated Power Assist Wheelchair PAPAW Phase I will examine whether the steady-state metabolic energy efficiency for propelling a manual wheelchair with and without the device will be significantly different In Phase II wheelchair users will evaluate the PAPAW over activities of daily living course to determine its usability and acceptability and to identify areas for future development Finally in phase III comparison of activities of daily living in the community will be made between the subjects when using their personal wheelchair and a PAPAW
Detailed Description:
Objectives
The purpose of this three phase study is to evaluate a Pushrim Activated Power Assist Wheelchair PAPAW Phase I will examine whether the steady-state metabolic energy efficiency for propelling a manual wheelchair with and without the device will be significantly different In Phase II wheelchair users will evaluate the PAPAW over activities of daily living course to determine its usability and acceptability and to identify areas for future development Finally in phase III comparison of activities of daily living in the community will be made between the subjects when using their personal wheelchair and a PAPAW
Research Design
This is a repeated measures design type study conducted in different locations for each phase a biomechanics laboratory an ADL driving course and the participants home environment Analyzed variables include metabolic energy expenditures stroke frequency upper extremity joint range of motion participant responses to a visual analog survey average speed and actual daily driving time spent in either wheelchair and daily distance traveled Subjects will act as their own controls
Methodology
Full-time wheelchair users with tetraplegia between the ages of 18 and 65 will be recruited for the study They will be free of pressure sores free from any shoulder pain that would prevent them from propelling a manual wheelchair and have no history of cardiopulmonary disease A maximum of 50 subjects fifteen for Phase I and II and 15 or Phase III and five for subject drop-out will be recruited In Phase I participants will be asked to propel a PAPAW and their own wheelchair attached to a wheelchair roller system through three resistance conditions In Phase II participants will be asked to propel both wheelchairs over activities of daily living Finally Phase III consists of a four-week trial including a two-week test with subjects own wheelchairs ie own chair trial and a two-week test where they were provided with the PAPAW ie PAPAW trial The order of the own chair trial and the PAPAW trial will be randomized
Clinical Relationship
For individuals with tetraplegia PAPAWs reduce energy demands stroke frequency and overall joint range of motion when compared to traditional manual wheelchair propulsion In addition PAPAWs have the potential to improve the functional capabilities during certain activities of daily living as well as community participation of individuals with tetraplegia Use of this device could help maintain overall physical capacity while reducing the risk for pain and injuries to the upper extremities
The purpose of this three phase study is to evaluate a Pushrim Activated Power Assist Wheelchair PAPAW Phase I will examine whether the steady-state metabolic energy efficiency for propelling a manual wheelchair with and without the device will be significantly different In Phase II wheelchair users will evaluate the PAPAW over activities of daily living course to determine its usability and acceptability and to identify areas for future development Finally in phase III comparison of activities of daily living in the community will be made between the subjects when using their personal wheelchair and a PAPAW
Research Design
This is a repeated measures design type study conducted in different locations for each phase a biomechanics laboratory an ADL driving course and the participants home environment Analyzed variables include metabolic energy expenditures stroke frequency upper extremity joint range of motion participant responses to a visual analog survey average speed and actual daily driving time spent in either wheelchair and daily distance traveled Subjects will act as their own controls
Methodology
Full-time wheelchair users with tetraplegia between the ages of 18 and 65 will be recruited for the study They will be free of pressure sores free from any shoulder pain that would prevent them from propelling a manual wheelchair and have no history of cardiopulmonary disease A maximum of 50 subjects fifteen for Phase I and II and 15 or Phase III and five for subject drop-out will be recruited In Phase I participants will be asked to propel a PAPAW and their own wheelchair attached to a wheelchair roller system through three resistance conditions In Phase II participants will be asked to propel both wheelchairs over activities of daily living Finally Phase III consists of a four-week trial including a two-week test with subjects own wheelchairs ie own chair trial and a two-week test where they were provided with the PAPAW ie PAPAW trial The order of the own chair trial and the PAPAW trial will be randomized
Clinical Relationship
For individuals with tetraplegia PAPAWs reduce energy demands stroke frequency and overall joint range of motion when compared to traditional manual wheelchair propulsion In addition PAPAWs have the potential to improve the functional capabilities during certain activities of daily living as well as community participation of individuals with tetraplegia Use of this device could help maintain overall physical capacity while reducing the risk for pain and injuries to the upper extremities
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 |
|---|---|---|---|
| H133N000019 | None | None | None |