Status:
RECRUITING
Pilot Study on the Evaluation of the Functionality, Safety and Reliability of New Tripping Devices for Lower Limbs.
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsors:
Biorobotic Institute Scuola Superiore sant'Anna Pisa
Conditions:
Lower Limb Amputation
Slip Perturbations
Eligibility:
All Genders
18-80 years
Brief Summary
The study aims to identify prognostic biomarkers of fall risk in patients with lower limb amputation
Detailed Description
The protocol will involve both trans-tibial and trans-femoral amputation subjects, for a total duration of up to 5 sessions. Initially, the fall detection algorithm will be evaluated on trans-femoral...
Eligibility Criteria
Inclusion
- 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
- Significant medical comorbidities (severe neurological disease, cardiovascular disease 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).
Key Trial Info
Start Date :
February 6 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06883942
Start Date
February 6 2024
End Date
June 1 2025
Last Update
March 19 2025
Active Locations (1)
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1
IRCCS Fondazione Don Carlo Gnocchi
Florence, Italy, 50143