Interventional Study on the Evaluation of Functionality, Safety of a Robotic Prosthesis for Transtibial Amputations

Interventional Pilot Study on the Evaluation of Functionality, Degree of Safety and Reliability of a New Robotic Prosthesis for Treatment of Transtibial Lower Limb Amputations

The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-tibial amputees.

The main question it aims to answer are:

• Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device.
• Provide an indication of the functional effectiveness of the device and its satisfaction by patients.

Participants will perform:

• walking tests inside parallel bars on flat and/or inclined terrain;
• walking tests on treadmill;
• stair climbing/descent tests.

Inclusion Criteria:

• Trans-tibial lower limb amputation;
• Medicare functional classification: Level K3-K4;
• Subjects who have worn prostheses for at least 1 year (experienced wearers);
• Use of prosthesis with energy-returning prosthetic foot.

Exclusion Criteria:

• Relevant medical comorbidities (serious neurological pathologies, cardiovascular pathologies, diabetes/hypertension not stabilized, severe sensory deficits);
• Wearers of implantable cardiac medical devices (PMK or AICD);
• Cognitive impairment (MMSE corrected for age and education <24);
• Inability or unavailability to provide informed consent;
• Severe depressive and/or anxious symptoms.