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

Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750372
• Other study ID #: 38227-G
• Status: Completed
• Phase: N/A
• First received: December 12, 2012
• Last updated: May 17, 2016
• Start date: April 2010
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1572
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Amputation

Locations

Country	Name	City	State
United States	South Florida Veterans Affairs Foundation for Research and Education	Miami	Florida
United States	University of Washington, UWCORR	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. 2015 May 5. pii: 0309364615579315. [Epub ahead of print] — View 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. — View 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 Feb 1. pii: S0003-9993(16)00045-9. doi: 10.1016/j.apmr.2016.01.010. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prosthetic Limb Users Survey of Mobility (PLUS-M)	PLUS-M is a self-reported measure of prosthetic mobility.	Single time point	No
Secondary	Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS) delivery of orthotics and prosthetics (O&P) services for persons with LLA.	The PEQ-MS is a self-reported measure of prosthetic mobility.	Single time point	No
Secondary	Patient Reported Outcomes Measurement Information Systems (PROMIS) brief profile	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.	Single time point	No
Secondary	Activities Specific Balance Confidence Scale (ABC)	The ABC is a self-reported measure of balance confidence.	Single time point	No

External Links

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