Pilot Study on the Evaluation of the Functionality, Safety and Reliability of New Tripping Devices for Lower Limbs.

Launched by FONDAZIONE DON CARLO GNOCCHI ONLUS · Mar 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying new devices designed to help people with lower limb amputations avoid falls. Researchers want to learn how well these devices work, how safe they are, and how reliable they can be in preventing slips and trips, which can be a significant risk for individuals with amputations. The goal is to find ways to better understand and predict who might be at risk of falling.

To participate in this study, you must be between the ages of 65 and 74 or 29 and 219, have either a trans-femoral (above the knee) or trans-tibial (below the knee) amputation, and have been using a prosthesis for at least one year. If you are selected, you will be asked to sign a consent form and will be monitored while using the new tripping devices. It's important to note that individuals with certain medical conditions, cognitive impairments, or severe mental health symptoms may not be eligible to participate. This trial aims to ultimately improve safety for those living with lower limb amputations.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Trans-femoral or trans-tibial lower limb amputation;
• • Functional medical classification: Level K3-K4;
• • Subjects who have had a prosthesis for at least 1 year (experienced wearers);
• • Informed consent signed by the subject
• Exclusion Criteria:
• • Significant medical comorbidities (severe neurological disease, cardiovascular disease diabetes/unstabilised hypertension, severe sensory deficits);
• • Cardiac device wearers (PMK or AICD);
• • Cognitive impairment (MMSE adjusted for age and schooling \<24);
• • Inability or unwillingness to provide informed consent;
• • Severe depressive symptomatology - Beck Depression Inventory (BDI-II \<19);
• • Severe anxiety symptoms - State-Trait Anxiety Inventory (STAI-Y \<50).