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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01750372
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : May 18, 2016
Information provided by (Responsible Party):

Study Description
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

Condition or disease

Study Design

Study Type : Observational
Actual Enrollment : 1572 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Client-Based Outcome System for Individuals With Lower Limb Amputation
Study Start Date : April 2010
Primary Completion Date : March 2016
Study Completion Date : March 2016
Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. Prosthetic Limb Users Survey of Mobility (PLUS-M) [ Time Frame: Single time point ]
    PLUS-M is a self-reported measure of prosthetic mobility.

Secondary Outcome Measures :
  1. Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS) delivery of orthotics and prosthetics (O&P) services for persons with LLA. [ Time Frame: Single time point ]
    The PEQ-MS is a self-reported measure of prosthetic mobility.

  2. Patient Reported Outcomes Measurement Information Systems (PROMIS) brief profile [ Time Frame: Single time point ]
    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.

  3. Activities Specific Balance Confidence Scale (ABC) [ Time Frame: Single time point ]
    The ABC is a self-reported measure of balance confidence.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Brian Hafner, University of Washington:
Artificial limbs
Mobility limitation