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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Brian Hafner, University of Washington
ClinicalTrials.gov Identifier:
First received: December 12, 2012
Last updated: May 26, 2015
Last verified: May 2015

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 Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Client-Based Outcome System for Individuals With Lower Limb Amputation

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 1380
Study Start Date: April 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Persons with lower limb amputation living in the United States

Inclusion Criteria:

(1) be over 18 years of age; (2) have a unilateral 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 either by (a) inconsistent responding to the study instruments or (b) a score of 24 or more on the MMSE.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01750372

United States, Florida
South Florida Veterans Affairs Foundation for Research and Education
Miami, Florida, United States, 33125
United States, Washington
University of Washington, UWCORR
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
Principal Investigator: Brian J Hafner, Ph.D University of Washington
  More Information

Additional Information:
Responsible Party: Brian Hafner, Assistant Professor, Rehabilitation Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT01750372     History of Changes
Other Study ID Numbers: 38227-G 
Study First Received: December 12, 2012
Last Updated: May 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Artificial limbs
Mobility limtiation

ClinicalTrials.gov processed this record on May 03, 2016