A Client-Based Outcome System for Individuals With Lower Limb Amputation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Amputation
- Sponsor
- University of Washington
- Enrollment
- 1572
- Locations
- 2
- Primary Endpoint
- Prosthetic Limb Users Survey of Mobility (PLUS-M)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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
Investigators
Brian Hafner
Assistant Professor, Rehabilitation Medicine
University of Washington
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Prosthetic Limb Users Survey of Mobility (PLUS-M)
Time Frame: Single time point
PLUS-M is a self-reported measure of prosthetic mobility.
Secondary Outcomes
- Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS) delivery of orthotics and prosthetics (O&P) services for persons with LLA.(Single time point)
- Patient Reported Outcomes Measurement Information Systems (PROMIS) brief profile(Single time point)
- Activities Specific Balance Confidence Scale (ABC)(Single time point)