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

Completed

• Conditions: Amputation

• Registration Number: NCT01750372
• Lead Sponsor: University of Washington

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-13
• Study First Posted: 2012-12-17
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1572

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prosthetic Limb Users Survey of Mobility (PLUS-M)	Single time point	PLUS-M is a self-reported measure of prosthetic mobility.

Secondary Outcome Measures

Name	Time	Method
Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS) delivery of orthotics and prosthetics (O&P) services for persons with LLA.	Single time point	The PEQ-MS is a self-reported measure of prosthetic mobility.
Patient Reported Outcomes Measurement Information Systems (PROMIS) brief profile	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.
Activities Specific Balance Confidence Scale (ABC)	Single time point	The ABC is a self-reported measure of balance confidence.

Trial Locations

Locations (2)

South Florida Veterans Affairs Foundation for Research and Education; 🇺🇸 Miami, Florida, United States

University of Washington, UWCORR; 🇺🇸 Seattle, Washington, United States