AmputationCP-PRO-01-20NCT05392907

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

An observational study of Amputation, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Amputation
How many people: 50 participants
Where: 1 siteItaly
Study dates: 23 Oct 2020to 23 Jul 2021
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

Severe comorbidities
Psychological impairment
Pregnancy
Patient not collaborative

Trial locations and contacts

1 site in 1 country.

Italy1 site

Centro Protesi Inail
Budrio, Bologna, 40054

Other trials in Italy

About this 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.

Conditions: Amputation

What is being measured

The primary outcome is the main question the study is designed to answer.

Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES)
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. Therefore, higher values represent a better outcome.
2. 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.
3. 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.
Measured: After recruitment, patient anamnesis is performed by an expert clinician. Then, the TAPES questionnaire is administered. The completion time is about 15 minutes
Score of the Prosthetic Mobility Questionnaire (PMQ)
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.
Measured: After completion of TAPES questionnaire, PMQ is administered. The completion time is about 3 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Oct 202023 Jul 2021

First posted26 May 2022
Study start23 Oct 2020
Primary completion23 Jul 2021
Study completion23 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AmputationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05392907
Sponsor's protocol ID: 747-2020-OSS-AUSLBO-20124
Acronym: CP-PRO-01-20
Status last verified: Apr 2025
First submitted: 11 May 2022
Last updated: 25 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Amputation trials

Study at a glance

From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Forensic-medical Aspects of Lower Limb Prosthetics: An Observational Study
ClinicalTrials.gov ID: NCT05392907
Acronym / sponsor ID: CP-PRO-01-20 / 747-2020-OSS-AUSLBO-20124
Conditions: Amputation
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul LavoroUniversity, hospital or other
Study start: 23 Oct 2020 (actual)
Primary completion: 23 Jul 2021 (actual)
Study completion: 23 Jul 2021 (actual)
First posted: 26 May 2022 (actual)
Results: Posted 25 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Cross-sectional

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: * Subjects with a unilateral lower limb amputation either trans-femural or trans-tibial * Age:18-65 years old

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

Severe comorbidities
Psychological impairment
Pregnancy
Patient not collaborative

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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: 1. 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. 2. 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. 3. 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.

Results and safety

Results posted to the registry on 25 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lower Limb Amputation	50	50

Primary outcome: 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. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Lower Limb Amputation n = 50
Psychosocial adjustment	57 (52 to 63.25)
Activity restriction	8 (4.75 to 11)
Prosthetic satisfaction	40 (37 to 44.25)

Primary outcome: Score of the Prosthetic Mobility Questionnaire (PMQ)

Time frame: After completion of TAPES questionnaire, PMQ is administered. The completion time is about 3 minutes.. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Lower Limb Amputation n = 50
Value	31.5 (25 to 35)

Adverse events

Time frame: 9 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lower Limb Amputation	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request

Related trials for Amputation

RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
CNS Changes Following Upper Limb Loss
Amputation, Congenital, Upper Limb; Amelia
Recruiting
Hand Prosthesis Usability and Performance
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Recruiting
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RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Amputation, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05392907.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.