Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices

NCT07066137 | Active Not Recruiting DMC

• 1 other identifier: Allena-mente
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate motor responses in healthy subjects and patients with movement disorders, brain and spinal cord injury, neuromuscular diseases, or cardiovascular diseases. 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.

Conditions

Healthy Individuals (Controls); Parkinson Disease; Multiple Sclerosis; Alzheimer Disease; Dementia; Stroke

Keywords

Virtual Reality; motor rehabilitation; cognitive rehabilitation; Functional Recovery

Outcome Measures

Primary Outcomes (1)

• Amplitude of Motor-Related Event-Related Potentials (ERPs) During Gesture Execution Assessed by EEG.

  Motor-related EEG activity will be recorded during the execution of standardized gestures. The primary outcome is the mean amplitude (in µV) of specific ERP components (e.g., N200, P300) over motor cortex electrodes. Data will be averaged across trials for each participant and reported as group means ± standard deviation. Differences between healthy participants and clinical groups will be assessed using appropriate statistical tests.

  Baseline (T0), post-intervention (T1, 12 weeks after baseline), and follow-up (T2, 3 months post-intervention).

Secondary Outcomes (2)

• Respiratory Exchange Ratio (RER) During Submaximal Exercis

  Baseline (T0), post-intervention (T1, 12 weeks after baseline), and follow-up (T2, 3 months post-intervention).

• Change in Global Cognitive Function as Measured by MoCA Total Score

  Baseline (T0), post-intervention (T1, 12 weeks after baseline), and follow-up (T2, 3 months post-intervention).

Study Arms (2)

Healthy Subjects

ACTIVE COMPARATOR

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.

Other: Control group

Experimental group

EXPERIMENTAL

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.

Device: CAREN

Interventions

CAREN DEVICE

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.

Experimental group

Control group OTHER

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

Healthy Subjects

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Montreal Cognitive Assessment (MoCA) score (adjusted for age and education) equal to or greater than 20.

You may not qualify if:

• Severe medical and psychiatric disorders potentially affecting the training

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Centro Neurolesi Bonino Pulejo

Messina, Italy/Me, 98123, Italy

Location

Related Publications (1)

• 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.

  PMID: 39011156 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Multiple Sclerosis; Alzheimer Disease; Dementia; Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Rocco Salvatore Calabrò, PhD

  IRCCS Centro Neurolesi Bonino Pulejo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this study: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MED, PhD

Model Details: Type of Study: Interventional Objective: To evaluate the effects of advanced physiotherapy techniques and neuromodulation on motor and cognitive functions in both healthy individuals and patients with neurological conditions. 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.

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: July 15, 2025
• Study Start: May 5, 2024
• Primary Completion: May 5, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Individual participant data (IPD) and supporting information will be available starting at the commencement of the study and will remain accessible for five years.
• Access Criteria: Access to individual participant data (IPD) and supporting information will be granted to qualified researchers, including academic institutions, healthcare organizations, and other entities involved in neurorehabilitation research. Researchers will be able to access the anonymized IPD, study protocols, and relevant supporting information such as assessment measures and data collection methods. Access will be facilitated through a secure online data-sharing platform, where approved users can download the data after signing a data use agreement that outlines the terms of use and ensures compliance with ethical guidelines and participant confidentiality. This process aims to promote collaboration while safeguarding the integrity and privacy of the participants involved in the study.

Locations

IT (1)