A Client-Based Outcome System for Individuals With Lower Limb Amputation

May 17, 2016 updated by: Brian Hafner, University of Washington

Standardized outcome measures can be used to document patient health outcomes and improve treatment of those requiring prosthetic and orthotic (O&P) services. Though numerous instruments have been developed, existing measures of O&P outcomes have serious shortcomings including limited evidence that the scores are responsive to clinical changes.

The investigators are developing the Prosthetic Limb Users Survey-Mobility (PLUS-M) using modern measurement methods to be a brief, precise and flexible measure of mobility for persons with lower limb amputation (LLA). The investigators propose the following objectives to achieve this goal.

Key objective 1: develop a measure (item bank) for measuring mobility in persons with lower limb loss

Key objective 2: study health profiles of lower limb prosthetic users

Key objective 3: validate the measure in a longitudinal study of people receiving replacement prosthetic limbs

Key objective 4: study longitudinal health patterns of persons with lower limb amputation

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1572

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

  • United States
    • Florida
      • Miami, Florida, United States, 33125
        • South Florida Veterans Affairs Foundation for Research and Education
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington, UWCORR

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Persons with lower limb amputation living in the United States

Description

Inclusion Criteria:

(1) be 18 years of age or older; (2) have a unilateral or bilateral amputation of the lower limb between the hip and knee or between the knee and ankle; (3) own and use a lower limb prostheses; (4) and be able to read, write, and understand spoken English.

Exclusion Criteria:

(1) do not currently use or do not intend to be fitted for a lower limb prosthesis; or (2) appear to have moderate to severe cognitive impairment, as evidenced by inconsistent responding to the study instruments.

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

Cohorts and Interventions

Group / Cohort
Persons with lower limb amputation
Persons with amputation below the hip and at or above the ankle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prosthetic Limb Users Survey of Mobility (PLUS-M)
Time Frame: Single time point
PLUS-M is a self-reported measure of prosthetic mobility.
Single time point

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS) delivery of orthotics and prosthetics (O&P) services for persons with LLA.
Time Frame: Single time point
The PEQ-MS is a self-reported measure of prosthetic mobility.
Single time point
Patient Reported Outcomes Measurement Information Systems (PROMIS) brief profile
Time Frame: Single time point
The Patient Reported Outcomes Measurement Information System (PROMIS) is a suite of reliable, precise, and meaningful self-report instruments designed to assess patients' health. PROMIS-29 is a 29-item survey designed to evaluate patients in seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, social role-participation, and pain interference.
Single time point
Activities Specific Balance Confidence Scale (ABC)
Time Frame: Single time point
The ABC is a self-reported measure of balance confidence.
Single time point

Collaborators and Investigators

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

Sponsor

University of Washington

Investigators

  • Principal Investigator: Brian J Hafner, Ph.D, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

April 1, 2010

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (ESTIMATE)

December 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38227-G

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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