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

University of Washington1,572 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,572

Conditions

Amputation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Outcomes

Primary Outcomes

Prosthetic Limb Users Survey of Mobility (PLUS-M)

PLUS-M is a self-reported measure of prosthetic mobility.

Time frame: Single time point

Secondary Outcomes

Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS) delivery of orthotics and prosthetics (O&P) services for persons with LLA.

The PEQ-MS is a self-reported measure of prosthetic mobility.

Time frame: Single time point

Patient Reported Outcomes Measurement Information Systems (PROMIS) brief profile

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.

Time frame: Single time point

Activities Specific Balance Confidence Scale (ABC)

The ABC is a self-reported measure of balance confidence.

Time frame: Single time point