Forensic-medical Aspects of Lower Limb Prosthetics: An Observational Study (CP-PRO-01-20)

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Status: Completed

Conditions: Amputation

Study type: Observational

Funder types: Other

Identifiers

NCT05392907

747-2020-OSS-AUSLBO-20124

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design