Amputation
Conditions
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.
Interventions
None listed
Sponsors
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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: 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) | 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. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lower Limb Amputation Subjects with a unilateral lower limb amputation, even trans-femural or trans-tibial | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Lower Limb Amputation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants |
| Age, Continuous | 50 years |
| Amputation level (trans-femural) | 25 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Region of Enrollment Italy | 50 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Lower Limb Amputation | Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES) | Psychosocial adjustment | 57 units on a scale |
| Lower Limb Amputation | Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES) | Activity restriction | 8 units on a scale |
| Lower Limb Amputation | Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES) | Prosthetic satisfaction | 40 units on a scale |
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.
Time frame: After completion of TAPES questionnaire, PMQ is administered. The completion time is about 3 minutes.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lower Limb Amputation | Score of the Prosthetic Mobility Questionnaire (PMQ) | 31.5 units on a scale |