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

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.

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Key information

Conditions

Amputation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Protesi Inail

Budrio, Bologna, 40054, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES)

Time frame: After recruitment, patient anamnesis is performed by an expert clinician. Then, the TAPES questionnaire is administered. The completion time is about 15 minutes
The questionnaire investigates three aspects of the quality of life of lower limb amputee subjects:
- psychosocial adjustment: 15 items, 5-point rating scale, score range: 15-75, higher scores indicates greater levels of adjustment. Therefore, higher values represent a better outcome.
- activity restriction: 12 items, 4-point rating scale, score range: 0-24, higher scores indicates greater activity restriction. Therefore, higher values represent a worse outcome.
- prosthetic satisfaction: 15 items, 5-point rating scale, score range: 10-50, higher scores indicates greater satisfaction with the prosthesis. Therefore, higher values represent a better outcome.
Results of psychosocial adjustment, activity restriction, and prosthetic satisfaction are presented separately.
Score of the Prosthetic Mobility Questionnaire (PMQ)

Time frame: After completion of TAPES questionnaire, PMQ is administered. The completion time is about 3 minutes.

The "Prosthetic Mobility Questionnaire" (PMQ), available in the Italian version, investigates self-perceived mobility through 12 items. Each item score ranges 0-4 for a total score ranging between 0 and 48. The higher the score, the higher the self-perceived level of mobility.

Sponsors and collaborators

Lead sponsor

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Other

Registry information

Acronym: CP-PRO-01-20

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: May 26, 2022
Registry last updated: May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed