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

March 7, 2007 updated by: University of Ottawa

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1M8H2
        • The Rehabilitation Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ottawa

Investigators

  • Study Director: Meridith B Marks, M.D., M.ed, University of Ottawa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

February 22, 2007

First Submitted That Met QC Criteria

February 22, 2007

First Posted (Estimate)

February 23, 2007

Study Record Updates

Last Update Posted (Estimate)

March 8, 2007

Last Update Submitted That Met QC Criteria

March 7, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TRC-0020-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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