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

RecruitingNAAges 18 Years - 85 YearsAllFondazione Don Carlo Gnocchi ETS
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to test a new digital therapeutic solution which combines a holistic, multidimensional rehabilitation program based on dance and music with an innovative motivational system (DANCEREX-DTx) in Chronic Neurological Disorders (Multiple Sclerosis and pre-Mild Cognitive Impairment - MCI/ MCI at risk of Alzheimer's Disease). The main questions it aims to answer are 1\] efficacy of the digital therapeutic solution in terms of adherence, clinical/functional measures, quality of life and surrogate measures; 2\] usability and acceptability of the system. Participants will be randomized (with an allocation ratio of 2:2:1) into the experimental group (DANCEREX - 24 sessions of multidimensional dance-based program integrated with an innovative motivational system), active comparator group (24 sessions of multidimensional dance-based program) and placebo group (24 s

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • DANCEREX-DTx
  • Multidimensional dance-based program
  • Educational Program
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Where

3 sites
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy
IRCCS Centro Neurolesi Bonino-Pulejo
Messina, Italy
IRCCS Fondazione Don Carlo Gnocchi ONLUS
Milan, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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