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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.
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| 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:
Results of psychosocial adjustment, activity restriction, and prosthetic satisfaction are presented separately. | 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. | After completion of TAPES questionnaire, PMQ is administered. The completion time is about 3 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Protesi Inail | Budrio | Bologna | 40054 | Italy |
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request
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| ID | Title | Description |
|---|---|---|
| FG000 | Lower Limb Amputation | Subjects with a unilateral lower limb amputation, even trans-femural or trans-tibial |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lower Limb Amputation | Subjects with a unilateral lower limb amputation, even trans-femural or trans-tibial |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES) | The questionnaire investigates three aspects of the quality of life of lower limb amputee subjects:
Results of psychosocial adjustment, activity restriction, and prosthetic satisfaction are presented separately. | Posted | Median | Inter-Quartile Range | units on a scale | After recruitment, patient anamnesis is performed by an expert clinician. Then, the TAPES questionnaire is administered. The completion time is about 15 minutes |
|
9 months
No adverse events may occur because the objective of the study is exclusively related to questionnaire completion
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lower Limb Amputation | Subjects with a unilateral lower limb amputation, even trans-femural or trans-tibial |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ing. Emanuele Gruppioni | INAIL | +39 051 6936 609 | e.gruppioni@inail.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 29, 2025 | Apr 29, 2025 | Prot_SAP_000.pdf |
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| Participants |
|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Amputation level (trans-femural) | Number | participants |
|
| Lower Limb Amputation |
People with unilateral trans-femoral or trans-tibial amputatio |
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| Primary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | After completion of TAPES questionnaire, PMQ is administered. The completion time is about 3 minutes. |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
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