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

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

1572 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2016-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Amputation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Persons with lower limb amputation

Persons with amputation below the hip and at or above the ankle

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No