A Client-Based Outcome System for Individuals With Lower Limb Amputation
Recruitment status was Recruiting
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. 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 Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||A Client-Based Outcome System for Individuals With Lower Limb Amputation|
- Prosthetic Limb Users Survey of Mobility (PLUS-M) [ Time Frame: Single time point ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The ABC is a self-reported measure of balance confidence.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Persons with lower limb amputation
Persons with amputation below the hip and at or above the ankle
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750372
|Contact: Brian Hafner, Ph.D.||firstname.lastname@example.org|
|Contact: Dagmar Amtmann, Ph.D.||email@example.com|
|United States, Florida|
|South Florida Veterans Affairs Foundation for Research and Education||Recruiting|
|Miami, Florida, United States, 33125|
|Contact: Ignacio Gaunaurd, MSPT 305-575-7000 Ignacio.Gaunaurd@va.gov|
|United States, Washington|
|University of Washington, UWCORR||Recruiting|
|Seattle, Washington, United States, 98105|
|Contact: Andre Kajlich 206-221-2414 firstname.lastname@example.org|
|Contact: Dagmar Amtmann, Ph.D. 206-221-2414 email@example.com|
|Principal Investigator: Brian Hafner, Ph.D.|
|Sub-Investigator: Dagmar Amtmann, Ph.D.|
|Principal Investigator:||Brian J Hafner, Ph.D||University of Washington|