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

NCT01750372 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1572

Last updated 2016-05-18

No results posted yet for this study

Summary

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

Conditions

  • Amputation

Sponsors & Collaborators

Principal Investigators

  • Brian J Hafner, Ph.D · University of Washington

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01750372 on ClinicalTrials.gov