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

NCT ID: NCT00439088

Last Updated: 2007-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2005-08-31

Brief Summary

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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

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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.

Conditions

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Amputee

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ottawa

OTHER

Sponsor Role lead

Principal Investigators

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Meridith B Marks, M.D., M.ed

Role: STUDY_DIRECTOR

University of Ottawa

Locations

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The Rehabilitation Centre

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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TRC-0020-02

Identifier Type: -

Identifier Source: org_study_id

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