Status:
COMPLETED
The CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus, 1st Clinical Study
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsors:
Scuola Superiore Sant'Anna di Pisa
Université Catholique de Louvain
Conditions:
Transfemoral Amputation
Eligibility:
All Genders
30-80 years
Phase:
NA
Brief Summary
The global goal of the CYBERnetic LowEr-limb coGnitive ortho-prosthesis Plus Plus (CLs++) project is to validate the technical and economic viability of the powered robotic ortho-prosthesis developed ...
Detailed Description
In the first clinical study, a set of combinations of the three hardware (HW) modules of the CLs++ ortho-prosthesis, namely the Active Trans-femoral Prosthesis (ATP), the Active Pelvis Orthosis (APO) ...
Eligibility Criteria
Inclusion
- Unilateral trans-femoral amputation (any cause)
- Completed the post amputation rehabilitation process
- Medicare Functional Classification Level ≤ K3
Exclusion
- Poor cognitive skills (Mini Mental State Examination)
- Severe anxiety or depression (State-Trait Anxiety Inventory Form Y and Beck Depression Inventory II, respectively)
- Relevant comorbidity (hemiplegia, degenerative nervous system diseases, hip or knee replacement, chronic heart failure, chronic obstructive pulmonary disease, act.)
- Stump pain/socket poor fitting
- Implantable cardiac devices (PMK and AICD)
- Inability to walk on a treadmill
Key Trial Info
Start Date :
June 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03296904
Start Date
June 26 2018
End Date
December 20 2019
Last Update
December 26 2019
Active Locations (1)
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1
Fondazione Don Carlo Gnocchi Onlus
Florence, Italy, 50143