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OpenTrials
Completed

NCT Number: NCT06284005

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

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.

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Key information

Conditions

Amputation Amputation, Traumatic Leg Injuries Leg Injury Lower Limb Injury Traumatic Amputation Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Fondazione Don Carlo Gnocchi

Florence, FI, 50143, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WRL ATP

Device

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

Primary outcomes

  1. ad hoc check-list Adverse Event

    Time frame: baseline

    questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

  2. ad hoc check-list Adverse Event

    Time frame: day 2

    questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

  3. ad hoc check-list Adverse Event

    Time frame: day 3

    questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

  4. ad hoc check-list Adverse Event

    Time frame: day 4

    questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

  5. ad hoc check-list Adverse Event

    Time frame: day 5

    questionnaire that evaluate the device feasibility of the prosthesis and description of any adverse events.

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

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

Acronym: MOTU-ATP

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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