NCT06616402

Assessing the Usability and Reliability of the Prototype Prosthesis Devices

MOTU++ - Studio Clinico Protesi

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of the present study is to verify the functionalitỳ, the degree of safety and the reliability of devices composed of an intelligent socket that allows the detection of biosignals and provides vibrotactile feedback and a prosthesis with active knee and ankle joints and a sensorised foot, for people with trans-femoral or trans-tibial amputation, which allows the optimisation of the gait cycle by providing active assistance at the knee and ankle joints according to the specific movement made by the user. The prototype devices are innovative in that they make it possible to optimise the benefits generated by the presence of actuated joints by exploiting the biosignals detected to ensure optimal functionalitỳ in the performance of activities̀ of daily living.

Conditions

• Amputation
• Traumatic Amputations
• Leg Amputation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-10-01
• Completion: 2025-12-31
• First posted: 2024-09-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Italy