A Client-Based Outcome System for Individuals With Lower Limb Amputation
|ClinicalTrials.gov Identifier: NCT01750372|
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : May 18, 2016
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
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1572 participants|
|Official Title:||A Client-Based Outcome System for Individuals With Lower Limb Amputation|
|Study Start Date :||April 2010|
|Primary Completion Date :||March 2016|
|Study Completion Date :||March 2016|
Persons with lower limb amputation
Persons with amputation below the hip and at or above the ankle
- Prosthetic Limb Users Survey of Mobility (PLUS-M) [ Time Frame: Single time point ]PLUS-M is a self-reported measure of prosthetic mobility.
- 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.
- 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.
- Activities Specific Balance Confidence Scale (ABC) [ Time Frame: Single time point ]The ABC is a self-reported measure of balance confidence.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750372
|United States, Florida|
|South Florida Veterans Affairs Foundation for Research and Education|
|Miami, Florida, United States, 33125|
|United States, Washington|
|University of Washington, UWCORR|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Brian J Hafner, Ph.D||University of Washington|