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NCT Number: NCT06893367

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

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.

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Key information

Conditions

Stroke 18 Years and Over Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Sensorimotor Impairment Affecting the Upper Limb Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Fondazione Don Carlo Gnocchi, Firenze

Florence, Italy

Location contact

Francesca Cecchi

CONTACT

[email protected]

055/73931

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

IMU and RealSense Cameras

Device

Each participant will perform the FMA-sens, with their most affected hand, followed by the FMA-sens with the less affected hand.

Primary outcomes

  1. Participants assessed by IMU

    Time frame: baseline

    The Fugl-Meyer Assessment (FMA) is obtained with IMU and RealSense cameras.

    Below are the individual items of the FMA that will be acquired via the experimental kit:

    • A II. Voluntary movement in synergy: flexor synergy/extensor synergy
    • A III. Voluntary movement with mixed synergies: hand to lumbar spine/shoulder flexion 0- 90/pronation-supination
    • A IV. Voluntary movement with reduced or absent synergy: shoulder abduction 0-90/shoulder flexion 90-180/pronation-supination
    • B I. Wrist: stability at 15° dorsiflexion with elbow 90°
    • B II. Wrist: repeated dorsiflexion with elbow 90°
    • B III. Wrist: Stability at 15° dorsiflexion with elbow at 0°
    • B IV. Wrist: repeated dorsiflexion with elbow at 0°
    • D. Coordination/Speed: tremor
    • D. Coordination/Speed: dysmetria
    • D. Coordination/Speed: time

  2. Participants assessed by IMU

    Time frame: at least 15 min from baseline

    The Fugl-Meyer Assessment (FMA) is obtained with IMU and RealSense cameras.

    Below are the individual items of the FMA that will be acquired via the experimental kit:

    • A II. Voluntary movement in synergy: flexor synergy/extensor synergy
    • A III. Voluntary movement with mixed synergies: hand to lumbar spine/shoulder flexion 0- 90/pronation-supination
    • A IV. Voluntary movement with reduced or absent synergy: shoulder abduction 0-90/shoulder flexion 90-180/pronation-supination
    • B I. Wrist: stability at 15° dorsiflexion with elbow 90°
    • B II. Wrist: repeated dorsiflexion with elbow 90°
    • B III. Wrist: Stability at 15° dorsiflexion with elbow at 0°
    • B IV. Wrist: repeated dorsiflexion with elbow at 0°
    • D. Coordination/Speed: tremor
    • D. Coordination/Speed: dysmetria
    • D. Coordination/Speed: time

  3. Participants assessed by IMU

    Time frame: at least 30 min from baseline

    The Fugl-Meyer Assessment (FMA) is obtained with IMU and RealSense cameras.

    Below are the individual items of the FMA that will be acquired via the experimental kit:

    • A II. Voluntary movement in synergy: flexor synergy/extensor synergy
    • A III. Voluntary movement with mixed synergies: hand to lumbar spine/shoulder flexion 0- 90/pronation-supination
    • A IV. Voluntary movement with reduced or absent synergy: shoulder abduction 0-90/shoulder flexion 90-180/pronation-supination
    • B I. Wrist: stability at 15° dorsiflexion with elbow 90°
    • B II. Wrist: repeated dorsiflexion with elbow 90°
    • B III. Wrist: Stability at 15° dorsiflexion with elbow at 0°
    • B IV. Wrist: repeated dorsiflexion with elbow at 0°
    • D. Coordination/Speed: tremor
    • D. Coordination/Speed: dysmetria
    • D. Coordination/Speed: time

Secondary outcomes

  1. Total FMA score

    Time frame: baseline

    Sensorimotor recovery assessment after stroke, total score from 0 to 64, subscore upper limb 36, lower limb 28. Higher scores represent better outcomes.

  2. MODIFIED BARTHEL INDEX (mBI)

    Time frame: baseline

    The Modified Barthel Index (MBI) is a tool used to assess a person's level of independence in performing activities of daily living, particularly in geriatrics and rehabilitation settings. It consists of 10 activities, such as eating, dressing, using the bathroom, moving around, and personal hygiene, each assigned a specific score. A higher score indicates greater independence, while a lower score reflects a higher level of dependence on assistance. The modified version of the Barthel Index is adapted from the original and is commonly used to track progress during rehabilitation or for patients with disabilities.

Study contacts

Contact information is provided by the study sponsor or research team.

Francesca Cecchi

CONTACT

[email protected]

055/73931

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • University of Bucharest
  • University of Florence

Registry information

Acronym: FMA-SENS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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