Clinical trial NCT01750372: A Client-Based Outcome System for Individuals With Lower Limb Amputation
Official title: A Client-Based Outcome System for Individuals With Lower Limb Amputation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Keywords: Artificial limbs
Questionnaires
Mobility limitation
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 1572
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with lower limb amputation living in the United States

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


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.

Primary outcomes:
measure: Prosthetic Limb Users Survey of Mobility (PLUS-M)
timeFrame: Single time point
Secondary outcomes:
measure: Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS) delivery of orthotics and prosthetics (O&P) services for persons with LLA.
timeFrame: Single time point
measure: Patient Reported Outcomes Measurement Information Systems (PROMIS) brief profile
timeFrame: Single time point
measure: Activities Specific Balance Confidence Scale (ABC)
timeFrame: Single time point
Other outcomes:
Locations:
city: Miami
country: United States
facility: South Florida Veterans Affairs Foundation for Research and Education
state: Florida
city: Seattle
country: United States
facility: University of Washington, UWCORR
state: Washington
Study officials:
affiliation: University of Washington
name: Brian J Hafner, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morgan SJ, Kelly VE, Amtmann D, Salem R, Hafner BJ. Self-Reported Cognitive Concerns in People With Lower Limb Loss. Arch Phys Med Rehabil. 2016 Jun;97(6):912-8. doi: 10.1016/j.apmr.2016.01.010. Epub 2016 Feb 1.
citation: Amtmann D, Morgan SJ, Kim J, Hafner BJ. Health-related profiles of people with lower limb loss. Arch Phys Med Rehabil. 2015 Aug;96(8):1474-83. doi: 10.1016/j.apmr.2015.03.024. Epub 2015 Apr 25.
citation: Hafner BJ, Morgan SJ, Abrahamson DC, Amtmann D. Characterizing mobility from the prosthetic limb user's perspective: Use of focus groups to guide development of the Prosthetic Limb Users Survey of Mobility. Prosthet Orthot Int. 2016 Oct;40(5):582-90. doi: 10.1177/0309364615579315. Epub 2015 May 5.
citation: Morgan SJ, Amtmann D, Abrahamson DC, Kajlich AJ, Hafner BJ. Use of cognitive interviews in the development of the PLUS-M item bank. Qual Life Res. 2014 Aug;23(6):1767-75. doi: 10.1007/s11136-013-0618-z. Epub 2014 Jan 20.
citation: Gaunaurd I, Spaulding SE, Amtmann D, Salem R, Gailey R, Morgan SJ, Hafner BJ. Use of and confidence in administering outcome measures among clinical prosthetists: Results from a national survey and mixed-methods training program. Prosthet Orthot Int. 2015 Aug;39(4):314-21. doi: 10.1177/0309364614532865. Epub 2014 May 14.
citation: Hafner BJ, Gaunaurd IA, Morgan SJ, Amtmann D, Salem R, Gailey RS. Construct Validity of the Prosthetic Limb Users Survey of Mobility (PLUS-M) in Adults With Lower Limb Amputation. Arch Phys Med Rehabil. 2017 Feb;98(2):277-285. doi: 10.1016/j.apmr.2016.07.026. Epub 2016 Aug 30.