Forensic-medical Aspects of Lower Limb Prosthetics: An Observational Study
Conditions: Amputation
Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

ClinicalTrials.gov ID: NCT05392907 
Unique Protocol ID: 747-2020-OSS-AUSLBO-20124 
 
 
Cover page 
 
Title 
Forensic-medical aspects of lower limb prosthetics: An observational study 
NCT number 
NCT05392907 
Date 
April 29th 2025 
 
 
 

ClinicalTrials.gov ID: NCT05392907 
Unique Protocol ID: 747-2020-OSS-AUSLBO-20124 
 
 
Study protocol 
Rationale 
The loss of a lower limb is an extremely disabling event that limits not only the ability of interaction 
with the outside world (Activities of Daily Living, ADLs), but impacts also on the representation of 
oneself. Many efforts have been implemented in the last two decades for the technological 
development of prostheses that can take the place of the lower limb. Furthermore, lower limb 
amputation also represents a relevant clinical condition from a medical-welfare point of view, and 
according to epidemiological studies it is destined to grow enormously in the coming decades, due to 
the aging of the general population and the increase of the number of subjects with chronic vascular 
and/or metabolic diseases. Likewise, over the years, thanks to the technological progress in the field 
of limb prostheses, a change in the condition of the prosthetic amputee have been observed. 
Nonetheless, past studies have shown the permanence of numerous problems: the majority of the 
population with lower limb amputation experience impaired mobility and a decreased physical 
abilities, pain syndromes (including phantom limb pain) and refer discomfort and dissatisfaction in 
wearing the prosthetic limb. Therefore, a precise definition of the impact of lower limb amputation 
on the activities of the daily life, mobility, work and social participation, and quality of life is 
fundamental to support the healthcare activities and services aiming at improving the quality of life 
of subjects with amputation. Such features of interest can be well investigated by the administration 
of questionnaires. The "Prosthetic Mobility Questionnaire" (PMQ), available in the Italian version, 
investigates self-perceived mobility through 12 items motor skills in the daily context. This 
questionnaire have demonstrated good psychometric properties in measuring mobility in subjects 
with lower limb amputation using a prosthesis. The “Trinity Amputation and Prosthesis Experience 
Scales” (TAPES), is a multidimensional self-administration tool, designed with the purpose of 
understanding the experience and adaptation of subjects using a prosthesis. It is divided into several 
sections that investigate psychosocial adaptation, restriction of motor and social-work activities, level 

ClinicalTrials.gov ID: NCT05392907 
Unique Protocol ID: 747-2020-OSS-AUSLBO-20124 
 
 
of satisfaction with the prosthesis, the presence of pain and other medical problems. In the medico-
legal field, the assessment and evaluation of psycho-physical suffering following a a traumatic event 
is a very topical and discussed topic, however there is still a lack of assessment tools and lack of 
clarity on the use of the existing ones, in providing a quantification of psycho-physical problems 
arising as a result of a damaging event.  
Objective 
To evaluate mobility and self-perception of individuals with a lower limb amputation. 
Endpoints 
1. Prosthetic mobility questionnaire (PMQ) 
2. Trinity Amputation and Prosthesis Experience Scales (TAPES) 
Study design 
Observational, cross-sectional, single arm. 
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 

ClinicalTrials.gov ID: NCT05392907 
Unique Protocol ID: 747-2020-OSS-AUSLBO-20124 
 
 
Drop-out criteria 
• Voluntary withdrawal 
Procedures 
The subject will be convoked by a clinical operator who will explain the finalities and modalities of 
the study. After the signature of the informed consent, the PMQ and TAPES questionnaire will be 
provided. Their completion will be done in a single session.  
Study duration: 12 months 
Statistical plan 
Descriptive statistics will be used to report aggregated values for the scores of TAPES and PMQ 
questionnaires. 
Specifically: 
• TAPES: each patient’s score is obtained by summing the value of each item. Then, an 
aggregated data is reported as mean value and minimum/maximum values of each patient’s 
score (unit of measure: units on a scale). 
• PMQ: each patient’s score is obtained by summing the value of each item. Then, an 
aggregated data is reported as median value and interquartile range (unit of measure: units on 
a scale). 
Demographic data have been collected only for management purposes, as per the internal guidelines 
of the rehabilitation centre. 
Results 
Aggregated data 
QUESTIONNAIRE 
 MEDIAN 
IQR 

ClinicalTrials.gov ID: NCT05392907 
Unique Protocol ID: 747-2020-OSS-AUSLBO-20124 
 
 
TAPES 
Psychosocial adjustment 
57 
52 – 63.25 
TAPES 
Activity restriction 
8 
4.75 - 11 
TAPES 
Prosthetic satisfaction 
40 
37 – 44.25 
PMQ2.0 
31.5 
25 - 35