MOTU++ - Studio Clinico Protesi

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age between 18 and 80 years;

• Lower limb amputation at the transfemoral or transtibial level;

• Functional medical classification: Level K3-K4 \[25\];

• Subjects wearing a prosthesis for at least 1 year (experienced wearers);

• Maximum body weight 100 kg.

Locations
Other Locations
Italy
IRCCS Fondazione Don Carlo Gnocchi
RECRUITING
Florence
Contact Information
Primary
Claudio Macchi, MD
cmacchi@dongnocchi.it
0557393909
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 15
Treatments
Other: prosthetic group performs the entire protocol with the prosthesis prototype.
Related Therapeutic Areas
Sponsors
Leads: Fondazione Don Carlo Gnocchi Onlus

This content was sourced from clinicaltrials.gov