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

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Amputation; Traumatic, Leg, Lower; Amputation

Treatments: Device: WRL TTP

Study type: Interventional

Funder types: Other

Identifiers

NCT06161961

MOTU TT - studio clinico

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

prosthetic group

Experimental group

Description:

prosthetic group performs the entire protocol with the prosthesis prototype.

Treatment:

Device: WRL TTP