N/A
N=50
Forensic-medical Aspects of Lower Limb Prosthetics: An Observational Study
Amputation
Bottom Line
View on ClinicalTrials.gov: NCT05392907 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES) — 57; 8; 40 units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES) |
57; 8; 40 | — |
| PRIMARY Score of the Prosthetic Mobility Questionnaire (PMQ) |
31.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05392907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.