An interventional study of IMU and RealSense Cameras in Stroke, Sensorimotor Impairment Affecting the Upper Limb and 18 Years and Over, sponsored by Fondazione Don Carlo Gnocchi Onlus. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Other
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 50 is close to the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
each participant will perform the FMA with IMU
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.
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
Time frame: 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
Time frame: 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
Time frame: at least 30 min from baseline
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.
Time frame: 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.
Time frame: baseline
Start is estimated for May 2025; primary completion for May 2026, 12 months later.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 12 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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