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

Amputation Clinical Trial

— CP-PRO-01-20  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05392907
• Other study ID #: 747-2020-OSS-AUSLBO-20124
• Status: Completed
• Start date: October 23, 2020
• Est. completion date: July 23, 2021

Study information

• Verified date: July 2020
• Source: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 23, 2021
• Est. primary completion date: July 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation

Locations

Country	Name	City	State
Italy	Centro Protesi Inail	Budrio	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.