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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00439088
First Posted: February 23, 2007
Last Update Posted: March 8, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Ottawa
  Purpose
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.

Condition Phase
Amputee Phase 1

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Comparison of the Patient Activity Monitor to a Pedometer During Ambulation Monitoring of Transtibial Amputees

Resource links provided by NLM:


Further study details as provided by University of Ottawa:

Estimated Enrollment: 20
Study Start Date: July 2005
Estimated Study Completion Date: August 2005
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439088


Locations
Canada, Ontario
The Rehabilitation Centre
Ottawa, Ontario, Canada, K1M8H2
Sponsors and Collaborators
University of Ottawa
Investigators
Study Director: Meridith B Marks, M.D., M.ed University of Ottawa
  More Information

ClinicalTrials.gov Identifier: NCT00439088     History of Changes
Other Study ID Numbers: TRC-0020-02
First Submitted: February 22, 2007
First Posted: February 23, 2007
Last Update Posted: March 8, 2007
Last Verified: March 2007

Keywords provided by University of Ottawa:
Ambulation
Ambulatory Monitoring
Activities of Daily Living
Pedometer
Validation Studies [PT]