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| Name | Class |
|---|---|
| Università degli Studi of Genova | UNKNOWN |
| University of Milan | OTHER |
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The driving idea of this project is to use new imaging techniques during 0functional movements to study relearning during a typical rehabilitation session.
The novelty of this project is to move from studies inquiring changes in brain activity patterns before and after rehabilitation toward a paradigm in which cortical activity is studied during the execution of the exercise. This would allow better understanding of cortical mechanisms underpinning functional improvements.
The project builds on preceding studies, partially funded by FISM, from the three research units involved in this project, aimed at assessing the impact of rehabilitation on mobility and balance and at assessing the effects of neurorehabilitation on brain plasticity. In this study, we will include 40 healthy subjects and a sample of 20 consecutive People with Multiple Sclerosis (PwMS), and we will investigate brain cortical activity during a typical session of task-oriented exercises. In specific, participants will undergo a treadmill training in which they will be required to keep their trunk and head stable in space using a biofeedback device. To study the effects of the session in improving dynamic stability, Head/trunk movements will be registered by inertial measurement units, while cortical activity will be concurrently assessed by functional near-infrared spectroscopy (fNIRS).
The first phase of the project will include healthy subjects and will be useful to understand the main cortical areas involved in the proposed motor tasks, in order to design the appropriate montage and protocol for fNIRS acquisition in PwMS. Finally, the analysis of the possible differences in cortical activation during different experimental conditions (e.g., biofeedback rehabilitation) in healthy subjects and PwMS will serve to develop a model for neurological rehabilitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple sclerosis | A sample of 20 consecutive PwMS will be recruited. | ||
| Healthy volunteers | We will recruit a group of healthy individuals to obtain normative reference data. These individuals will be matched for sex and age with the subjects having multiple sclerosis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Head and trunk movements quantified with Inertial Measurement Units (IMU) | The following variables are calculated: (1) the angular displacements in the sagittal and frontal planes, calculated as 1 standard deviation (SD) from the angular displacement data; and the head and angular velocities, which are the root mean square of the first derivative of angular displacements in the sagittal and frontal planes. | Baseline |
| Cortical activation with Functional Infrared Spettroscopy (fNIRS) | fNIRS data analysis will identify the acquisition channels (and hence the cortical areas) significantly active in the different experimental conditions. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 10 Meters walking test | The 10-Meter Walking Test (10MWT) is a commonly used assessment to measure walking speed and functional mobility, especially in individuals with neurological conditions like multiple sclerosis | Baseline |
| Twelve-Item Multiple Sclerosis Walking Scale (MSWS_12) |
| Measure | Description | Time Frame |
|---|---|---|
| Expanded Disability Status Scale (EDSS) | The EDSS is a widely used scale for measuring the level of disability in individuals with multiple sclerosis (MS). Developed by Kurtzke in 1955, it assesses both the severity of neurological impairment and the degree of disability in various functional systems. The score ranges from 0 to 10, with higher scores indicating a higher degree of disability. | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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People with Multiple sclerosis people affiliated with the rehabilitation center of the IRCCS Santa Maria Nascente of the Don Gnocchi Foundation will be recruited. Participants should be able to maintain upright posture without any assistance for 30 seconds, and to walk without any assistance.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università di Genova | Recruiting | Genova | 16126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31469359 | Background | Prosperini L, Di Filippo M. Beyond clinical changes: Rehabilitation-induced neuroplasticity in MS. Mult Scler. 2019 Sep;25(10):1348-1362. doi: 10.1177/1352458519846096. | |
| 16003668 | Background | Cattaneo D, Ferrarin M, Frasson W, Casiraghi A. Head control: volitional aspects of rehabilitation training in patients with multiple sclerosis compared with healthy subjects. Arch Phys Med Rehabil. 2005 Jul;86(7):1381-8. doi: 10.1016/j.apmr.2004.12.029. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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to assess walking perceived ability of people with multiple sclerosis. The score ranges from 12 to 60, with higher scores indicating a higher degree of walking impairment. |
| Baseline |
| Modified Fatigue Impact Scale (MFIS) | To assess the perceived impact of fatigue in people with multiple sclerosis. The score ranges from 0 to 84, with higher scores indicating a higher degree of fatigue. | Baseline |
| Beck Depression Inventory (BDI-II) | To monitor anxiety and depression. The score ranges from 0 to 63, with higher scores indicating a higher degree of depression. | Baseline |
| IRCCS Santa Maria Nascente - Fondazione Don Carlo Gnocchi | Recruiting | Milan | 20148 | Italy |
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| Università degli Studi di Milano | Active, not recruiting | Milan | 20148 | Italy |
| 32806516 | Background | Bonilauri A, Sangiuliano Intra F, Pugnetti L, Baselli G, Baglio F. A Systematic Review of Cerebral Functional Near-Infrared Spectroscopy in Chronic Neurological Diseases-Actual Applications and Future Perspectives. Diagnostics (Basel). 2020 Aug 12;10(8):581. doi: 10.3390/diagnostics10080581. |
| 41973556 | Derived | Torchio A, Mattos FGM, Bove M, Iester C, Cattaneo D, Bonzano L, Gervasoni E. Cortical and Kinematic Correlates of Feedback-Based Head Stabilization During Treadmill Walking. IEEE Trans Neural Syst Rehabil Eng. 2026;34:2024-2033. doi: 10.1109/TNSRE.2026.3683304. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |