A Client-Based Outcome System for Individuals With Lower Limb Amputation
Completed
Conditions studied: Amputation
In brief
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
Key facts
- Study ID
- NCT01750372
- Run by
- University of Washington
- People needed
- 1572
- Starts
- 2010-04-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2016-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- (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.
You may not qualify if…
- (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.
Where it is running
- South Florida Veterans Affairs Foundation for Research and Education — Miami, Florida, United States
- University of Washington, UWCORR — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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