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

Sponsor
University of Ottawa (Other)
Overall Status
Completed
CT.gov ID
NCT00439088
Collaborator
(none)
20
Enrollment
1
Location
1
Duration (Months)
19.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Observational Model:
    Defined Population
    Time Perspective:
    Other
    Official Title:
    Comparison of the Patient Activity Monitor to a Pedometer During Ambulation Monitoring of Transtibial Amputees
    Study Start Date :
    Jul 1, 2005
    Study Completion Date :
    Aug 1, 2005

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 80 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00439088
      Other Study ID Numbers:
      • TRC-0020-02
      First Posted:
      Feb 23, 2007
      Last Update Posted:
      Mar 8, 2007
      Last Verified:
      Mar 1, 2007
      Keywords provided by , ,
      Ambulation
      Ambulatory Monitoring
      Activities of Daily Living
      Pedometer
      Validation Studies [PT]

      Study Results

      No Results Posted as of Mar 8, 2007