StrokeFMA-SENSNCT06893367
Reliability of Sensor-Derived Measurements of the SENSorized Fugl-Meyer (FMA) in Subjects with Stroke Outcomes
A study testing IMU and RealSense Cameras in people with Stroke and Sensorimotor Impairment Affecting the Upper Limb, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Sensorimotor Impairment Affecting the Upper Limb, 18 Years and Over
- What is being tested?
- IMU and RealSense Cameras
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- May 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Fondazione Don Carlo Gnocchi, Firenze
Florence
Francesca Cecchi, 055/73931, fcecchi@dongnocchi.it
About this study
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.
Read more
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.
- Being tested
- IMU and RealSense Cameras
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMU and RealSense CamerasDevice
Each participant will perform the FMA-sens, with their most affected hand, followed by the FMA-sens with the less affected hand.
| Study group | Role | What they receive |
|---|---|---|
| Stroke group | Experimental | each participant will perform the FMA with IMU Receives: Device: IMU and RealSense Cameras |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants assessed by IMU
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
Measured: baseline
Participants assessed by IMU
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
Measured: at least 15 min from baseline
Participants assessed by IMU
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
Measured: at least 30 min from baseline
Secondary outcomes (2)
Total FMA score
Sensorimotor recovery assessment after stroke, total score from 0 to 64, subscore upper limb 36, lower limb 28. Higher scores represent better outcomes.
Measured: baseline
MODIFIED BARTHEL INDEX (mBI)
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florence, University of Bucharest
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893367
- Sponsor's protocol ID
- FMA-SENS
- Acronym
- FMA-SENS
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Sensor-Derived Measurements of the SENSorized Fugl-Meyer (FMA) in Subjects with Stroke Outcomes
- ClinicalTrials.gov ID
- NCT06893367
- Acronym / sponsor ID
- FMA-SENS / FMA-SENS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- University of Florence, University of Bucharest
- Study start
- May 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke group | Experimental | Device: IMU and RealSense Cameraseach participant will perform the FMA with IMU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMU and RealSense CamerasEach participant will perform the FMA-sens, with their most affected hand, followed by the FMA-sens with the less affected hand. | Device | Stroke group |
Primary outcome
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
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
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
2 secondary outcomes
Total FMA score
Time frame: baseline
MODIFIED BARTHEL INDEX (mBI)
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMU and RealSense Cameras in people with Stroke and Sensorimotor Impairment Affecting the Upper Limb, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Cecchi (055/73931, fcecchi@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants assessed by IMU (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.