Reliability of Sensor-Derived Measurements of the SENSorized Fugl-Meyer (FMA) in Subjects with Stroke Outcomes

Launched by FONDAZIONE DON CARLO GNOCCHI ONLUS · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device designed to measure how well people recover from stroke, specifically focusing on their arm and hand movements. The goal is to see if this device can provide reliable and accurate information about a person's upper limb function. The trial will involve 50 participants who have had a stroke and are experiencing difficulties with their arm movements. Participants will be recruited from rehabilitation centers in Florence, Italy, and Bucharest, Romania.

To be eligible for the study, participants must be at least 18 years old and have sensorimotor impairment in their upper limbs as a result of a stroke. They should also be willing to participate and provide consent. During the trial, participants will undergo several assessments where sensors will be placed on their arms to measure their movements. This will help researchers gather important data on their recovery. It's important to note that this device is still in development and not yet available for general use.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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).