Trial Outcomes & Findings for Forensic-medical Aspects of Lower Limb Prosthetics: An Observational Study (NCT NCT05392907)

NCT ID: NCT05392907

Last Updated: 2025-05-25

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 50 participants
• Primary outcome timeframe: After recruitment, patient anamnesis is performed by an expert clinician. Then, the TAPES questionnaire is administered. The completion time is about 15 minutes
• Results posted on: 2025-05-25

Participant Flow

Participant milestones

Measure	Lower Limb Amputation Subjects with a unilateral lower limb amputation, even trans-femural or trans-tibial
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Lower Limb Amputation n=50 Participants Subjects with a unilateral lower limb amputation, even trans-femural or trans-tibial
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	50 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Italy	50 participants n=5 Participants
Amputation level (trans-femural)	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Lower Limb Amputation n=50 Participants People with unilateral trans-femoral or trans-tibial amputatio
Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES) Psychosocial adjustment	57 units on a scale Interval 52.0 to 63.25
Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES) Activity restriction	8 units on a scale Interval 4.75 to 11.0
Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES) Prosthetic satisfaction	40 units on a scale Interval 37.0 to 44.25

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Lower Limb Amputation n=50 Participants People with unilateral trans-femoral or trans-tibial amputatio
Score of the Prosthetic Mobility Questionnaire (PMQ)	31.5 units on a scale Interval 25.0 to 35.0

Adverse Events

Lower Limb Amputation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ing. Emanuele Gruppioni

INAIL

Phone: +39 051 6936 609

Email: e.gruppioni@inail.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place