Forensic-medical Aspects of Lower Limb Prosthetics: An Observational Study (CP-PRO-01-20)

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 Overview

• Status: Completed
• Conditions: Amputation

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Italy
  • Bologna
    • Budrio, Bologna, Italy, 40054
      • Centro Protesi Inail

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

• Subjects with a unilateral lower limb amputation either trans-femural or trans-tibial
• Age:18-65 years old

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES)	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;; activity restriction: 12 items, 4-point rating scale, score range: 12-48, higher scores indicates greater activity restriction;; 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.	After recruitment, patient anamnesis is performed by an expert clinician. Then, the TAPES questionnaire is administered. The completion time is about 15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire: Prosthetic Mobility Questionnaire (PMQ)	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.	After completion of TAPES questionnaire, the PMQ questionnaire is administered. The completion time is about 3 minutes.

Collaborators and Investigators

• Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2020
• Primary Completion (Actual): July 23, 2021
• Study Completion (Actual): July 23, 2021

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 747-2020-OSS-AUSLBO-20124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No