A Client-Based Outcome System for Individuals With Lower Limb Amputation

NCT01750372 | Completed

• 1 other identifier: 38227-G
• Study Type: observational
• Target: 1,572
• Locations: 1 country
• Sites: 2

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

Conditions

Amputation

Keywords

Artificial limbs; Questionnaires; Mobility limitation

Outcome Measures

Primary Outcomes (1)

• Prosthetic Limb Users Survey of Mobility (PLUS-M)

  PLUS-M is a self-reported measure of prosthetic mobility.

  Single time point

Secondary Outcomes (3)

• 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

Study Arms (1)

Persons with lower limb amputation

Persons with amputation below the hip and at or above the ankle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons with lower limb amputation living in the United States

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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (2)

South Florida Veterans Affairs Foundation for Research and Education

Miami, Florida, 33125, United States

Location

University of Washington, UWCORR

Seattle, Washington, 98105, United States

Location

Related Publications (6)

• 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.

  PMID: 26836953 BACKGROUND

• 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.

  PMID: 25917819 BACKGROUND

• 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.

  PMID: 25944625 BACKGROUND

• 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.

  PMID: 24442531 BACKGROUND

• 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.

  PMID: 24827935 BACKGROUND

• 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.

  PMID: 27590443 DERIVED

Related Links

• The University of Washington Center on Outcomes Research in Rehabilitation (UWCORR)

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian J Hafner, Ph.D

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Rehabilitation Medicine

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: December 17, 2012
• Study Start: April 1, 2010
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 18, 2016

Record last verified: 2016-05

Locations

US (2)