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Search / Trial NCT06112639

The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders

Launched by FONDAZIONE DON CARLO GNOCCHI ONLUS · Oct 27, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Rehabilitation Multiple Sclerosis Dementia Digital Therapeutics Neurocognitive Dysfunction Mri Neuroinflammation Telerehabilitation

ClinConnect Summary

The DANCEREX Proof-of-Concept Study is looking to test a new digital program designed to help people with chronic neurological disorders, such as Multiple Sclerosis and early stages of memory problems. This program combines dance and music with a motivational system to encourage participation in rehabilitation. The study will compare three groups: one group will use the new dance program with the motivational system, another group will do dance sessions without the added motivational features, and the third group will participate in an educational program. Researchers want to see if the dance-based approach helps improve adherence to treatment, overall health, and quality of life for participants.

To participate in this study, individuals must be between 18 and 85 years old, have a diagnosis of Multiple Sclerosis or pre-Mild Cognitive Impairment, and be able to understand and sign a consent form. Participants should also have some level of education and be capable of performing basic cognitive tasks. However, those with serious balance issues, significant hearing or vision problems, or who need assistance to live independently are not eligible. If you join, you can expect to engage in 24 sessions of the program over a set period, and you’ll be part of a study that aims to bring more effective rehabilitation options for those facing these neurological challenges.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. age between 18 and 85 years (adult and older adult);
  • 2. education equal to or more than five years
  • 3. agreement to participate with the signature of the informed consent form;
  • 4. clinical diagnosis of Multiple Sclerosis (MS) according to the 2017 revised criteria of MC Donald - Expanded Disability Status Scale (EDSS) score equal or less than 4.5, R-R disease course, freedom from relapses, and steroid treatment for at least one month, OR clinical diagnosis of pre-Mild Cognitive Impairment - MCI (Subjective Memory Complaints and/or Subjective Cognitive Complaints)/MCI at risk of Alzheimer's Disease with the Clinical Dementia Rating (CDR) scale equal or less than 0.5
  • 5. Normal score to a screening test for cognitive impairment (Montreal Cognitive Assessment test - MoCA test \> 15.5 Santangelo et al., 2015)
  • Exclusion Criteria:
  • 1. presence of comorbidities that prevent patients from undertaking a safe home program (e.g., balance problems, history of falls in the past 6 months, use of assistive devices for deambulation)
  • 2. presence of overt hearing/visual impairment
  • 3. for the MCI group, the absence of a caregiver/study partner able to support the participant;
  • 4. no living in one's own home;
  • 5. for the MS group, score in cerebellum function at EDSS greater than 3

About Fondazione Don Carlo Gnocchi Onlus

Fondazione Don Carlo Gnocchi Onlus is a distinguished non-profit organization dedicated to advancing healthcare and rehabilitation services for individuals with disabilities and chronic illnesses. Established in honor of the legacy of Don Carlo Gnocchi, the foundation focuses on integrating scientific research with clinical practice, striving to enhance the quality of life for patients through innovative therapies and comprehensive care programs. With a commitment to excellence, the foundation actively engages in clinical trials and research initiatives aimed at improving treatment outcomes and fostering a deeper understanding of rehabilitation methodologies. Its collaborative approach brings together healthcare professionals, researchers, and community stakeholders to promote well-being and support patient-centric solutions.

Locations

Brescia, , Italy

Milan, , Italy

Messina, , Italy

Patients applied

0 patients applied

Trial Officials

Maria Pia Amato

Principal Investigator

IRCCS Fondazione Don Carlo Gnocchi ONLUS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported