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

Sponsor
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro (Other)
Overall Status
Completed
CT.gov ID
NCT05392907
Collaborator
(none)
50
Enrollment
1
Location
9
Actual Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Forensic-medical Aspects of Lower Limb Prosthetics: An Observational Study
    Actual Study Start Date :
    Oct 23, 2020
    Actual Primary Completion Date :
    Jul 23, 2021
    Actual Study Completion Date :
    Jul 23, 2021

    Outcome Measures

    Primary Outcome Measures

    1. 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: 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.

    Secondary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centro Protesi Inail Budrio Bologna Italy 40054

    Sponsors and Collaborators

    • Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
    ClinicalTrials.gov Identifier:
    NCT05392907
    Other Study ID Numbers:
    • 747-2020-OSS-AUSLBO-20124
    First Posted:
    May 26, 2022
    Last Update Posted:
    May 26, 2022
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 26, 2022