Status:
NOT_YET_RECRUITING
Reliability of Sensor-Derived Measurements of the SENSorized Fugl-Meyer (FMA) in Subjects with Stroke Outcomes
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsors:
University of Florence
University of Bucharest
Conditions:
Stroke
Sensorimotor Impairment Affecting the Upper Limb
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will be conducted at a single research center, the main objective of the study will be to evaluate the efficacy, safety, and accuracy of a medical device that has not yet been commercialize...
Eligibility Criteria
Inclusion
- age 18 years or older;
- stroke outcomes with the presence of sensorimotor impairment in the upper limb;
- willingness to participate in the project, with informed consent signed by the person himself or, when necessary, by the support administrator/legal guardian.
Exclusion
- Severe concomitant pathologies that modify the subject's motor framework;
- severe visual and/or hearing impairments that cannot be corrected;
- severe neuropsychological impairments (aphasia, apraxia, other cognitive deficits ) such as to prevent cooperation in administering the scale;
- presence of signs of clinical instability, defined by a score greater than zero on the SIC scale (Clinical Instability Scale).
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06893367
Start Date
May 1 2025
End Date
May 1 2026
Last Update
March 25 2025
Active Locations (1)
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1
IRCCS Fondazione Don Carlo Gnocchi, Firenze
Florence, Italy