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

Completed

• Conditions: Amputation

• Registration Number: NCT05392907
• Lead Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study Start: 2020-10-23
• Primary Completion: 2021-07-23
• Study Completion: 2021-07-23
• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-23
• Last Update Submitted: 2022-05-23
• Study First Posted: 2022-05-26
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES)	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: 1. psychosocial adjustment: 15 items, 5-point rating scale, score range: 15-75, higher scores indicates greater levels of adjustment; 2. activity restriction: 12 items, 4-point rating scale, score range: 12-48, higher scores indicates greater activity restriction; 3. prosthetic satisfaction: 15 items, 5-point rating scale, score range: 15-75, higher scores indicates greater satisfaction with the prosthesis.; In addition the survey presents a final section which explores residual pain, phantom limb pain and other medical problems.

Secondary Outcome Measures

Name	Time	Method
Questionnaire: Prosthetic Mobility Questionnaire (PMQ)	After completion of TAPES questionnaire, the PMQ questionnaire is administered. The completion time is about 3 minutes.	The questionnaire investigates the self-perceived mobility iof lower-limb amputee subjects. It consists of a 12-item, 5-level response format questionnaire. The items cover a wide range of activities that are presented from the easiest (e.g. "To walk indoors") to the hardest (e.g. "To run a block"). Score range is 0-48 with higher values representing a better perceived mobility.

Trial Locations

Locations (1)

Centro Protesi Inail; 🇮🇹 Budrio, Bologna, Italy