A Client-Based Outcome System for Individuals With Lower Limb Amputation
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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.
- 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 |
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.
Contacts and Locations| Contact: Brian Hafner, Ph.D. | 206-221-2414 | uwcorr@u.washington.edu |
| Contact: Dagmar Amtmann, Ph.D. | 206-221-2414 | uwcorr@u.washington.edu |
| 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. | |
| 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 May 21, 2013