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

This study is currently recruiting participants.
Verified December 2012 by University of Washington
Sponsor:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01750372
First received: December 12, 2012
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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


Condition
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 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Persons with lower limb amputation
Persons with amputation below the hip and at or above the ankle

  Eligibility

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

Criteria

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.

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

Contacts
Contact: Brian Hafner, Ph.D. 206-221-2414 uwcorr@u.washington.edu
Contact: Dagmar Amtmann, Ph.D. 206-221-2414 uwcorr@u.washington.edu

Locations
United States, Florida
South Florida Veterans Affairs Foundation for Research and Education Recruiting
Miami, Florida, United States, 33125
Contact: Ignacio Gaunaurd, MSPT    305-575-7000    Ignacio.Gaunaurd@va.gov   
United States, Washington
University of Washington, UWCORR Recruiting
Seattle, Washington, United States, 98105
Contact: Andre Kajlich    206-221-2414    uwcorr@uw.edu   
Contact: Dagmar Amtmann, Ph.D.    206-221-2414    uwcorr@uw.edu   
Principal Investigator: Brian Hafner, Ph.D.         
Sub-Investigator: Dagmar Amtmann, Ph.D.         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Brian J Hafner, Ph.D University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01750372     History of Changes
Other Study ID Numbers: A51517
Study First Received: December 12, 2012
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Artificial limbs
Questionnaires
Mobility limtiation

ClinicalTrials.gov processed this record on April 23, 2014