CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Key inclusion· 4
  • Aged 18–65 years
  • Unilateral trans-femoral or trans-tibial amputation
  • At least 2 years of prosthesis use experience
  • Written informed consent provided
Key exclusion· 4
  • Severe comorbidities
  • Psychological impairment
  • Pregnancy
  • Not collaborative with study requirements

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05392907
NCT05392907N/ACompleted

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

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro·observational·Posted May 26, 2022·Updated May 25, 2025

In Brief

An observational study for Amputation. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAmputation
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 26, 2022
Enrollment StartOct 23, 2020
Primary CompletionJul 23, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.1 years ago