Status:
COMPLETED
Interventional Study on the Evaluation of Functionality, Safety of a Robotic Prosthesis for Transtibial Amputations
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Conditions:
Amputation
Amputation; Traumatic, Leg, Lower
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-tibial amputees. The main question it aims to answer are: * Is to verify the technical func...
Eligibility Criteria
Inclusion
- Trans-tibial lower limb amputation;
- Medicare functional classification: Level K3-K4;
- Subjects who have worn prostheses for at least 1 year (experienced wearers);
- Use of prosthesis with energy-returning prosthetic foot.
Exclusion
- Relevant medical comorbidities (serious neurological pathologies, cardiovascular pathologies, diabetes/hypertension not stabilized, severe sensory deficits);
- Wearers of implantable cardiac medical devices (PMK or AICD);
- Cognitive impairment (MMSE corrected for age and education \<24);
- Inability or unavailability to provide informed consent;
- Severe depressive and/or anxious symptoms.
Key Trial Info
Start Date :
July 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT06161961
Start Date
July 21 2020
End Date
December 22 2022
Last Update
December 8 2023
Active Locations (1)
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1
IRCCS Fondazione Don Carlo Gnocchi
Florence, FI, Italy, 50143