Phase
Condition
N/ATreatment
prosthetic group performs the entire protocol with their own prosthesis
Experimental Group
Clinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Trans-femoral or trans-tibial lower limb amputation;
Functional medical classification: Level K3-K4;
Subjects who have had a prosthesis for at least 1 year (experienced wearers);
Informed consent signed by the subject
Exclusion
Exclusion Criteria:
Significant medical comorbidities (severe neurological disease, cardiovasculardisease diabetes/unstabilised hypertension, severe sensory deficits);
Cardiac device wearers (PMK or AICD);
Cognitive impairment (MMSE adjusted for age and schooling <24);
Inability or unwillingness to provide informed consent;
Severe depressive symptomatology - Beck Depression Inventory (BDI-II <19);
Severe anxiety symptoms - State-Trait Anxiety Inventory (STAI-Y <50).
Study Design
Study Description
Connect with a study center
IRCCS Fondazione Don Carlo Gnocchi
Florence, 50143
ItalyActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.