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

NCT05392907 | Completed Results

• 1 other identifier: 747-2020-OSS-AUSLBO-20124
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Subjects with a unilateral lower limb amputation either trans-femural or trans-tibial * Age:18-65 years old

You may qualify if:

• 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

You may not qualify if:

• Severe comorbidities
• Psychological impairment
• Pregnancy
• Patient not collaborative

Sponsors & Collaborators

• Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro: lead

Study Sites (1)

Centro Protesi Inail

Budrio, Bologna, 40054, Italy

Location

Results Point of Contact

• Title: Ing. Emanuele Gruppioni
• Organization: INAIL

e.gruppioni@inail.it

+39 051 6936 609

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 26, 2022
• Study Start: October 23, 2020
• Primary Completion: July 23, 2021
• Study Completion: July 23, 2021
• Last Updated: May 25, 2025
• Results First Posted: May 25, 2025

Record last verified: 2025-04

Locations

IT (1)