A Client-Based Outcome System for Individuals With Lower Limb Amputation
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|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|
|Actual Primary Completion Date :||March 2016|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|