Assessing the Usability and Reliability of the Prototype Prosthesis Devices

NARecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

November 1, 2023

Primary Completion Date

October 1, 2024

Study Completion Date

June 1, 2025

Conditions
AmputationTraumatic AmputationsLeg Amputation
Interventions
DEVICE

prototype prosthetic group

"These 3 sessions will commence only upon successful completion of the prosthesis safety and reliability tests conducted in the preceding sessions.~For each module combination, a session will be conducted to assess motor performance through the acquisition of spatiotemporal parameters and energy efficiency parameters of gait. Motor performance will be evaluated using functional assessment tests and data will be recorded during the following activities:~* parallel bar walking on flat ground~* parallel bar walking on an inclined surface~* treadmill walking with a safety harness~* stair climbing/descending with a handrail~* standing up and sitting down from a chair within parallel bars At the end of each session, satisfaction questionnaires (ad hoc questionnaire) will be completed. At the end of the experiment, a usability scale for the devices (ad hoc System Usability Scale) will be completed.~Each session is expected to last approximately 2.5 hours."

Trial Locations (1)

50143

RECRUITING

IRCCS Fondazione Don Carlo Gnocchi, Florence

All Listed Sponsors
lead

Fondazione Don Carlo Gnocchi Onlus

OTHER