Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
NCT ID: NCT07066137
Last Updated: 2025-07-15
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
150 participants
INTERVENTIONAL
2024-05-05
2026-12-31
Brief Summary
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This study aims to evaluate the effectiveness of traditional physical activities combined with innovative interventions such as cryotherapy, ultrasound therapy, laser therapy, transcranial magnetic stimulation (TMS), and transcranial direct current stimulation (tDCS). It will also assess the impact of proprioceptive stimuli provided by either the immersive virtual reality (CAREN), or visuo-cognitive-motor enhancement (S.V.T.A.), and music therapy.
The main questions it aims to answer are:
How do these interventions affect motor activities and their functional recovery? What are the temporal and spatial changes in activation sequences related to motor learning and maintenance? When there is a comparison group: Researchers will compare outcomes between different intervention arms (e.g., physical activity with advanced devices vs. traditional methods) to find out if the advanced interventions result in better motor control and functional recovery.
Participants will:
* Undergo various rehabilitation protocols including physical activity and advanced interventions.
* Be assessed using different tool, such as fMRI, dtMRI, and NIRS to study in vivo neuroimaging and assess changes in brain function and connectivity.
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Detailed Description
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Primary Objectives Investigating Motor Gesture Control: Study the sensory-motor structures and their connectivity in healthy participants and patients with neurological, cardiovascular, or neuromuscular conditions. This includes analyzing responses to advanced interventions such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), and the CAREN (Computer Assisted Rehabilitation Environment) system.
Understanding Central Control Mechanisms: Assess spatial and temporal changes in brain activity during motor training and recovery processes, leveraging advanced neuroimaging techniques (e.g., fMRI, dtMRI, NIRS).
Secondary Objectives Postural Disorder Prevention: Develop strategies to enhance postural stability and prevent related disorders, improving sports performance and the quality of life in patients with neurodegenerative conditions.
Integration of Imaging and Psychometric Data: Employ multimodal data to uncover brain function patterns and inform rehabilitation strategies, contributing to personalized recovery protocols and optimized training methods.
Methodology Study Design
This is an interventional study aimed at evaluating the metabolic, functional, and neurophysiological aspects of motor responses in participants subjected to intensive physical and cognitive training. By combining traditional therapies with innovative technologies (e.g., CAREN, tDCS, TMS), the study will explore:
Central nervous system activation and connectivity. Temporal and spatial dynamics of motor learning and maintenance. The role of proprioceptive, visual, and auditory inputs in motor coordination.
Phases of Study Phase 1: Recruitment and Baseline Assessments Participants will be recruited through direct communication and provided with detailed study information.
Baseline evaluations will include:
Clinical and medical-sports assessment. Neuropsychological evaluation (e.g., MoCA, TMT, Stroop Test). Postural and gait analysis. Baseline imaging (MRI, EEG). Phase 2: Intervention and Data Collection
Participants will undergo structured interventions:
Physiotherapy sessions combined with neuromodulation techniques. Training on the CAREN system to assess and improve motor and postural functions.
Use of advanced devices for electromyographic data collection, oxygen consumption measurements, and 3D gait analysis.
Imaging and functional assessments will be repeated post-intervention.
Phase 3: Data Analysis and Dissemination Collected data will be anonymized, processed using advanced imaging and statistical algorithms, and analyzed for correlations between training responses and functional recovery.
Results will be published in high-impact international journals. Technologies and Assessments
Neuroimaging Techniques:
Functional and structural MRI (including T1-weighted, T2-weighted, and DTI sequences).
Analysis of mean diffusivity and fractional anisotropy to evaluate white matter integrity.
NIRS to assess cortical hemodynamics during tasks.
Neurophysiological Tools:
EEG and ECG to monitor the electrical activity of the brain and heart. Surface electromyography (EMG) to evaluate muscle activation patterns.
Advanced Rehabilitation Devices:
CAREN system: A virtual environment platform for motor and postural rehabilitation.
Alter-G/Gait Trainer 3 for assisted gait training. FLIR system for thermal imaging of muscular activity.
Neuropsychological Assessments:
Comprehensive cognitive evaluation, including MoCA, TMT, Stroop, and PASAT. Auditory anamnesis and visuomotor training (e.g., S.V.T.A.).
Population The study aims to recruit 150 participants, including healthy individuals and patients aged 18-60 years with neurological conditions (stroke, dementia, Parkinson's Disease, Multiple Sclerosis, Spinal Cord Injury). Detailed inclusion and exclusion criteria ensure the selection of suitable candidates.
Ethical and Administrative Aspects All participants will provide informed consent per ethical guidelines (Declaration of Helsinki and GDPR compliance).
The relevant Ethics Committee approves the study, with no additional costs or compensations.
Results will be transparently reported, adhering to international research standards.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Interventions: Physiotherapy, Cryotherapy, ultrasound therapy, laser therapy, music therapy, Neuromodulation: TMS, tDCS, Virtual Reality (CAREN) Proprioceptive stimulation and motor rehab, Intensive aerobic and anaerobic training.
Groups:
1. Healthy Participants
2. Patients
Phases:
Recruitment: Initial evaluations and baseline data collection. Intervention: Application of treatments and regular assessments. Follow-up: Post-intervention evaluations and data analysis. Duration: Approximately 5 years. Outcome Measures: Improvements in motor performance, cognitive functions, and quality of life.
TREATMENT
DOUBLE
Investigator: Not masked; investigators will be aware of the intervention each participant receives to monitor and administer the assigned treatments.
Outcomes Assessor: Masked to the intervention each participant receives to ensure an unbiased evaluation of outcomes.
Participants: Not masked; participants are aware of the intervention they are receiving as it involves different types of therapies and exercises.
Data Analysts: Masked to participant group assignments during initial data analysis to prevent bias in interpreting results.
Study Groups
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Healthy Subjects
The subjects will undergo baseline examinations including MRI, spirometry, surface electromyography, 3D gait analysis, postural assessment and stabilometric analysis, O2 consumption measurement, neuropsychological assessment, ECG, and EEG.
Subsequently, the healthy subjects (approximately 50) will undergo intensive aerobic and anaerobic training (including sensory-motor-cognitive training) and exercises on the CAREN platform. For the other 25 participants, transcranial magnetic stimulation (TMS)/transcranial direct current stimulation (tDCS) and music therapy will be added.
Control group
the control group is typically the group that does not receive the experimental treatment or intervention, serving as a baseline to compare the effects of the intervention. However, in the context you're describing with healthy subjects and athletes, here's how it's structured:
Healthy subjects and athletes (around 50 participants) will undergo:
Intensive aerobic and anaerobic training Sensory-motor-cognitive training
Additionally, 25 of these participants will receive:
Transcranial Magnetic Stimulation (TMS) Transcranial Direct Current Stimulation (tDCS) Music therapy This approach allows for a comparison between the effects of the physical and cognitive training alone versus the enhanced effects when combined with neuromodulation (TMS, tDCS) and music therapy. This design will help in assessing the added value of these interventions on performance
Experimental group
As for the neurological patients (50), they will undergo posture and gait rehabilitation using the CAREN platform, while the other 25 will receive additional enhancement through non-invasive neuromodulation. This constitutes the other arm of the study.
CAREN
The interventions include proprioceptive stimuli combined with specific rehabilitation protocols, such as Tabata training, plyometric training, and visual-cognitive-motor enhancement with the S.V.T.A. method.
Healthy subjects and athletes (about 50) will participate in intensive aerobic and anaerobic training, including sensory-motor-cognitive training and exercises on the CAREN platform. Another 25 participants will have TMS/tDCS and music therapy added to their regimen.
Regarding neurological patients, 50 participants will undergo posture and gait rehabilitation using the CAREN platform, while 25 will receive non-invasive neuromodulation to enhance their rehabilitation outcomes. This arm of the study focuses on the recovery of motor and cognitive functions.
This study uses the CAREN system as a tool for physical rehabilitation in neurological and healthy participants. The device is not being investigated for new indications and the study is conducted entirely in Italy.
Interventions
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CAREN
The interventions include proprioceptive stimuli combined with specific rehabilitation protocols, such as Tabata training, plyometric training, and visual-cognitive-motor enhancement with the S.V.T.A. method.
Healthy subjects and athletes (about 50) will participate in intensive aerobic and anaerobic training, including sensory-motor-cognitive training and exercises on the CAREN platform. Another 25 participants will have TMS/tDCS and music therapy added to their regimen.
Regarding neurological patients, 50 participants will undergo posture and gait rehabilitation using the CAREN platform, while 25 will receive non-invasive neuromodulation to enhance their rehabilitation outcomes. This arm of the study focuses on the recovery of motor and cognitive functions.
This study uses the CAREN system as a tool for physical rehabilitation in neurological and healthy participants. The device is not being investigated for new indications and the study is conducted entirely in Italy.
Control group
the control group is typically the group that does not receive the experimental treatment or intervention, serving as a baseline to compare the effects of the intervention. However, in the context you're describing with healthy subjects and athletes, here's how it's structured:
Healthy subjects and athletes (around 50 participants) will undergo:
Intensive aerobic and anaerobic training Sensory-motor-cognitive training
Additionally, 25 of these participants will receive:
Transcranial Magnetic Stimulation (TMS) Transcranial Direct Current Stimulation (tDCS) Music therapy This approach allows for a comparison between the effects of the physical and cognitive training alone versus the enhanced effects when combined with neuromodulation (TMS, tDCS) and music therapy. This design will help in assessing the added value of these interventions on performance
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
Yes
Sponsors
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IRCCS Centro Neurolesi Bonino Pulejo
OTHER
Responsible Party
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Rocco Salvatore Calabrò
MED, PhD
Principal Investigators
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Rocco Salvatore Calabrò, PhD
Role: STUDY_DIRECTOR
IRCCS Centro Neurolesi Bonino Pulejo
Locations
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IRCCS Centro Neurolesi Bonino Pulejo
Messina, Italy/Me, Italy
Countries
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References
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Bonanno M, De Pasquale P, De Marchis C, Lombardo Facciale A, Paladina G, Fonti B, Quartarone A, Calabro RS. Might patients with cerebellar ataxia benefit from the Computer Assisted Rehabilitation ENvironment (CAREN)? A pilot study focusing on gait and balance. Front Bioeng Biotechnol. 2024 Jun 24;12:1385280. doi: 10.3389/fbioe.2024.1385280. eCollection 2024.
Other Identifiers
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Allena-mente
Identifier Type: -
Identifier Source: org_study_id
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