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

NCT ID: NCT05392907

Last Updated: 2025-05-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-23

Study Completion Date

2021-07-23

Brief Summary

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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

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Conditions

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Amputation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centro Protesi Inail

Budrio, Bologna, Italy

Site Status

Countries

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Italy

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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747-2020-OSS-AUSLBO-20124

Identifier Type: -

Identifier Source: org_study_id

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