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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01750372

Enrollment

1572

Registered

2012-12-17

Start date

2010-04-30

Completion date

2016-03-31

Last updated

2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation

Keywords

Artificial limbs, Questionnaires, Mobility limitation

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Activities Specific Balance Confidence Scale (ABC)	Single time point	The ABC is a self-reported measure of balance confidence.
Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS) delivery of orthotics and prosthetics (O&P) services for persons with LLA.	Single time point	The PEQ-MS is a self-reported measure of prosthetic mobility.
Patient Reported Outcomes Measurement Information Systems (PROMIS) brief profile	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.

Countries

United States

Outcome results