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

Study Overview
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Brief Summary
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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

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

Conditions
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Amputation

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Persons with lower limb amputation<br>Persons with amputation below the hip and at or above the ankle | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prosthetic Limb Users Survey of Mobility (PLUS-M) | PLUS-M is a self-reported measure of prosthetic mobility. | Single time point | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Activities Specific Balance Confidence Scale (ABC) | The ABC is a self-reported measure of balance confidence. | Single time point | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial limbs, Questionnaires, Mobility limitation