Try Walking a Mile in These Shoes: Activity Level of Lower Extremity Amputees

Amputee Clinical Trial

— PamPed  

Official title:

Comparison of the Patient Activity Monitor to a Pedometer During Ambulation Monitoring of Transtibial Amputees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439088
• Other study ID #: TRC-0020-02
• Status: Completed
• Phase: Phase 1
• First received: February 22, 2007
• Last updated: March 7, 2007
• Start date: July 2005
• Est. completion date: August 2005

Study information

• Verified date: March 2007
• Source: University of Ottawa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Unilateral transtibial amputees who were identified as community level ambulators (K-Level 3)

Exclusion Criteria:

• Malfunction of prosthesis; or

• New medical co-morbidities that impacted on ambulation.

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Amputee

Locations

Country	Name	City	State
Canada	The Rehabilitation Centre	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Ottawa

Country where clinical trial is conducted

Canada,