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

Overview

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.

Interventions

• Device IMU and RealSense Cameras
  Each participant will perform the FMA-sens, with their most affected hand, followed by the FMA-sens with the less affected hand.

Primary outcome measures

• Participants assessed by IMU [Time frame: baseline]
• Participants assessed by IMU [Time frame: at least 15 min from baseline]
• Participants assessed by IMU [Time frame: at least 30 min from baseline]

Secondary outcome measures (2)

• Total FMA score [Time frame: baseline]
• MODIFIED BARTHEL INDEX (mBI) [Time frame: baseline]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

Italy · 1 center

• IRCCS Fondazione Don Carlo Gnocchi, Firenze — Florence

Identifiers

NCT: NCT06893367 · FMA-SENS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗