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

Completed

• Conditions: Amputation

• Registration Number: NCT05392907
• Lead Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-23
• Primary Completion: 2021-07-23
• Study Completion: 2021-07-23
• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-23
• Study First Posted: 2022-05-26
• Results First Submitted: 2023-03-22
• Status Verified: 2025-04
• Results First Submitted QC: 2025-05-23
• Last Update Submitted: 2025-05-23
• Results First Posted: 2025-05-25
• Last Update Posted: 2025-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES)	After recruitment, patient anamnesis is performed by an expert clinician. Then, the TAPES questionnaire is administered. The completion time is about 15 minutes	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.
Score of the Prosthetic Mobility Questionnaire (PMQ)	After completion of TAPES questionnaire, PMQ is administered. The completion time is about 3 minutes.	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.

Trial Locations

Locations (1)

Centro Protesi Inail; 🇮🇹 Budrio, Bologna, Italy