Study on the Functionality, Safety and Reliability of a Robotic Prosthesis for the Lower Limb At the Transfemoral Level (MOTU-ATP)

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Traumatic Amputation; Lower Limb Injury; Leg Injury; Amputation

Treatments: Device: WRL ATP

Study type: Interventional

Funder types: Other

Identifiers

NCT06284005

MOTU ATP - Studio clinico

Details and patient eligibility

About

The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-femoral 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: 4 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• trans femoural amputation
• Medicare Functional Classification Levels k3-k4
• expert prosthesis wearer (more than one year)
• electronic knee prostheses user
• energy-release prosthetic foot user

Exclusion criteria

• Relevant medical comorbidities
• heart device wearers (PMK or AICD)
• cognitive impairment
• anxious or depressed illness

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

prosthetic group

Experimental group

Description:

prosthetic group performs the entire protocol with the prosthesis prototype.

Treatment:

Device: WRL ATP