Forensic-medical Aspects of Lower Limb Prosthetics: An Observational Study

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro50 enrolled

Overview

The study investigated the perceived-mobility of patients with unilateral lower limb amputations by means of patient-reported outcome measures (PROMs). Such aspect may play an important role in evaluating the patient impairment and addressing forensic-medical issues. However, to this concern, the use of PROMs has not been extensively investigated yet. Among the validated PROMs, the study assessed self-perceived mobility and quality of life by administering the Trinity Amputation Prosthetic Evaluation Survey (TAPES) and the more recent Prosthetic Mobility Questionnaire (PMQ). The aim of this observational study was to improve the estimation of the physical and psychological impairment caused by the amputation, focusing on the impact of the limb loss on social participation, quality of life and daily living activities.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Amputation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects aged between 18 and 65 years * Unilateral trans-femural or trans-tibial amputation * Experienced prosthesis users (at least two years) * Subjects that provided written informed consent to study participation and data publication Exclusion Criteria: * Severe comorbidities * Psychological impairment * Pregnancy * Patient not collaborative

Locations (1)

Centro Protesi Inail

Outcomes

Primary Outcomes

Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES)

The questionnaire investigates three aspects of the quality of life of lower limb amputee subjects: 1. psychosocial adjustment: 15 items, 5-point rating scale, score range: 15-75, higher scores indicates greater levels of adjustment. Therefore, higher values represent a better outcome. 2. activity restriction: 12 items, 4-point rating scale, score range: 0-24, higher scores indicates greater activity restriction. Therefore, higher values represent a worse outcome. 3. prosthetic satisfaction: 15 items, 5-point rating scale, score range: 10-50, higher scores indicates greater satisfaction with the prosthesis. Therefore, higher values represent a better outcome. Results of psychosocial adjustment, activity restriction, and prosthetic satisfaction are presented separately.

Time frame: After recruitment, patient anamnesis is performed by an expert clinician. Then, the TAPES questionnaire is administered. The completion time is about 15 minutes

Score of the Prosthetic Mobility Questionnaire (PMQ)

The "Prosthetic Mobility Questionnaire" (PMQ), available in the Italian version, investigates self-perceived mobility through 12 items. Each item score ranges 0-4 for a total score ranging between 0 and 48. The higher the score, the higher the self-perceived level of mobility.

Time frame: After completion of TAPES questionnaire, PMQ is administered. The completion time is about 3 minutes.