An observational study in Amputation, sponsored by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro · Observational
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.
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
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.
Time frame: After completion of TAPES questionnaire, PMQ is administered. The completion time is about 3 minutes.
| Milestone | Lower Limb Amputation |
|---|---|
| Started | 50 |
| Completed | 50 |
| Not completed | 0 |
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.
| units on a scale | Lower Limb Amputation |
|---|---|
| Psychosocial adjustment | 57 (52 to 63.25) |
| Activity restriction | 8 (4.75 to 11) |
| Prosthetic satisfaction | 40 (37 to 44.25) |
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.
| units on a scale | Lower Limb Amputation |
|---|---|
| Score of the Prosthetic Mobility Questionnaire (PMQ) | 31.5 (25 to 35) |
Collected over 9 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lower Limb Amputation | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Categorical(Participants) | Lower Limb Amputation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 50 |
| >=65 years | 0 |
| Age, Continuous(years) | Lower Limb Amputation |
|---|---|
| Median | 50 (23 to 64) |
| Sex: Female, Male(Participants) | Lower Limb Amputation |
|---|---|
| Female | 8 |
| Male | 42 |
| Race (NIH/OMB)(Participants) | Lower Limb Amputation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 50 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Lower Limb Amputation |
|---|---|
| Italy | 50 |
| Amputation level (trans-femural)(participants) | Lower Limb Amputation |
|---|---|
| Number | 25 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro