Pilot Study on the Evaluation of the Functionality, Safety and Reliability of New Tripping Devices for Lower Limbs.

RecruitingOBSERVATIONAL
Enrollment

30

Participants

Timeline

Start Date

February 6, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
Lower Limb AmputationSlip PerturbationsFall Risk
Interventions
PROCEDURE

prosthetic group performs the entire protocol with their own prosthesis

"The 1st session is the enrolment and functional evaluation one. The following 2 we test the algorithm functionality verification; one session for both platforms. The last 2 sessions are necessary to acquire prognostic markers for falls; one session for both platforms.~The balance disturbance tests will take place on two platforms:~* The sliding platform consists of a metal supporting structure and a wooden cover, which has a manual release mechanism that allows the activation of the tile responsible for simulating the events that occur during sliding.~* The stumbling platform consists of a metal supporting structure and a wooden cover, which features an electronically activated plastic and foam tripping mechanism that simulates the sequence of events that occur during a stumble."

DEVICE

Experimental Group

The fall detection algorithm will be evaluated first. In a second step, the experimentally obtained prognostic markers of fall risk will be studied. The markers thus obtained shall be validated by comparison with markers already established in clinical practice or in the literature.

Trial Locations (1)

50143

RECRUITING

IRCCS Fondazione Don Carlo Gnocchi, Florence

All Listed Sponsors
collaborator

Biorobotic Institute Scuola Superiore sant'Anna Pisa

UNKNOWN

lead

Fondazione Don Carlo Gnocchi Onlus

OTHER