Study on the Functionality, Safety and Reliability of a Robotic Prosthesis for the Lower Limb At the Transfemoral Level

Multicentre Interventional Pilot Study on the Evaluation of the Functionality, Safety and Reliability of a New Robotic Prosthesis for the Lower Limb At the Transfemoral Level

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06284005

Acronym

MOTU-ATP

Enrollment

Registered

2024-02-28

Start date

2020-07-27

Completion date

2022-12-22

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation, Leg Injury, Lower Limb Injury, Traumatic Amputation

Keywords

lower limb, transfemoral

Brief summary

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.

Interventions

DEVICEWRL ATP

evaluation of functionality, degree of safety and reliability of the lower limb prosthesis prototype

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
ad hoc check-list Adverse Event	baseline	questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026