Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00439088
Status:
COMPLETED
Last Update Posted:
2007-03-08
First Post:
2007-02-22
Brief Title:
Try Walking a Mile in These Shoes Activity Level of Lower Extremity Amputees
Sponsor:
University of Ottawa
Organization:
University of Ottawa
Study Overview
Official Title:
Comparison of the Patient Activity Monitor to a Pedometer During Ambulation Monitoring of Transtibial Amputees
Status:
COMPLETED
Status Verified Date:
2007-03
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:
PamPed
Brief Summary:
The purpose of this study is to compare the accuracies of the Patient Activity Monitor to that of a standard pedometer during a walking task and some day-to-day activities in a simulated apartment setting
Detailed Description:
The ability to accurately measure daily activity levels in lower extremity amputee patients is important for a better understanding of their use of prosthetic limbs Most studies have shown that patients often report their activity level inaccurately More objective data on activity levels will not only provide information helpful for determining the appropriate prosthetic components for an individual it will also be helpful when assessing the effects that medical illness have on activity levels and in objectively determining the benefits of rehabilitation In addition being able to measure activity accurately will allow further verification of currently developed clinical surveys designed to determine amputee activity in a practical form
Until more recently a practical accurate and affordable means of monitoring lower extremity amputee activity has not been available for use Currently a monitoring device designed specifically for this task is available for research use It is called the Patient Activity Monitor PAM Many different models of more generic activity monitoring devices called pedometers also exist and need to be further tested in the amputee population
The objective of our study was to measure and compare the step count and ambulation distance accuracies of a Yamax Digi-Walker pedometer and the PAM in transtibial amputees at the K3 Level within a simulated apartment setting and during relatively continuous gymnasium walking
Until more recently a practical accurate and affordable means of monitoring lower extremity amputee activity has not been available for use Currently a monitoring device designed specifically for this task is available for research use It is called the Patient Activity Monitor PAM Many different models of more generic activity monitoring devices called pedometers also exist and need to be further tested in the amputee population
The objective of our study was to measure and compare the step count and ambulation distance accuracies of a Yamax Digi-Walker pedometer and the PAM in transtibial amputees at the K3 Level within a simulated apartment setting and during relatively continuous gymnasium walking
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