Clinical trial NCT06893367: Reliability of Sensor-Derived Measurements of the SENSorized Fugl-Meyer (FMA) in Subjects with Stroke Outcomes
Official title: Reliability of Sensor-Derived Measurements of the SENSorized Fugl-Meyer (FMA) in Subjects with Stroke Outcomes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Sensorimotor Impairment Affecting the Upper Limb
18 Years and Over
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: University of Florence
name: University of Bucharest
First posted: 2025-03-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 commercialized; therefore, it is still under development or testing and is not yet available for private use and is not for profit (nonprofit).

Fifty participants will be recruited from subjects afferent to the outpatient and inpatient neuro-motor rehabilitation clinics of IRCCS Fondazione Don Carlo Gnocchi in Florence, Italy, and afferent to the outpatient and inpatient rehabilitation clinics of Elias University Emergency Hospital in Bucharest, Romania.

In detail, it is deemed necessary to collect clinical and instrumental data. The study will be conducted by an interdisciplinary team composed of healthcare professionals and engineers afferent to the Department of Industrial Engineering.

Should you decide to participate in the study, a visit to verify the inclusion and exclusion criteria will be primarily conducted. Once the admission criteria have been verified, participants will undergo a series of assessments.

The first, involves the administration of some specific sections of the Fugl-Meyer scale (FMA), focusing on the upper extremities. Specifically, the following will be examined: section A for general upper limb function, section B assessing wrist mobility, and finally section D for limb coordination and speed.

During this phase, both upper limbs will be assessed, in addition, the first examiner will carefully place sensors on the participants and assign scores to the tests performed, according to the criteria established by the FMA scale.

Next, a second assessment (T1) will be conducted, in which a second examiner will be responsible for placing the sensors and recording data only on the most affected side.

At a third time, called "T2" and again with at least 15 minutes interval from T1, the first examiner will repeat the same assessments performed in "T1." While performing these assessments, a RealSense camera will be used.


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).

Primary outcomes:
measure: Participants assessed by IMU
timeFrame: baseline
measure: Participants assessed by IMU
timeFrame: at least 15 min from baseline
measure: Participants assessed by IMU
timeFrame: at least 30 min from baseline
Secondary outcomes:
measure: Total FMA score
timeFrame: baseline
measure: MODIFIED BARTHEL INDEX (mBI)
timeFrame: baseline
Other outcomes:
Locations:
city: Florence
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi, Firenze
Study officials:
References: