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NCT03816345
Arthritis, Arthritis, Psoriatic
Birmingham, Alabama, United States
View Trial DetailsNCT Number: NCT06826638
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Observational
Università di Genova, Genova, Italy
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
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.
Time frame: Baseline
fNIRS data analysis will identify the acquisition channels (and hence the cortical areas) significantly active in the different experimental conditions.
Time frame: Baseline
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
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
To monitor anxiety and depression. The score ranges from 0 to 63, with higher scores indicating a higher degree of depression.
Time frame: Baseline
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.
Fondazione Don Carlo Gnocchi ETS
Other
Investigate Neuro-rehabilitation Active Ingredients of Specific Task-oriented Training In People With Multiple Sclerosis With Different Challenging Conditions and Extrinsic Feedbacks
Acronym: INSIDE
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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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