NCT05392907

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

Name: Clinical Trial NCT05392907
Creator: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Keywords: Amputation, clinical trial, Italy

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro·ClinicalTrials.govCompleted

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Study focus

Disease/Condition: Amputation
Study type: Observational

Sponsor & location

Primary sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Location: Budrio, Italy

Timeline & enrollment

Phase: N/A
Start date: Oct 23, 2020
End date: Jul 23, 2021
Enrollment: 50 participants

Primary outcome

Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES)

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.

ICD-10 classifications

Amputation of limb(s)Traumatic amputation of both feetTraumatic amputation of upper and lower limbs, any combination [any level]Traumatic amputations involving other combinations of body regionsTraumatic amputation of lower leg

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05392907
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05392907 through Pure Global AI's free database. This phase not specified trial is sponsored by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro and is currently Completed. The study focuses on Amputation. Target enrollment is 50 participants.

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