The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders
Recruiting · NCT06112639 · Interventional (participants receive a specific treatment) · Lead sponsor: Fondazione Don Carlo Gnocchi ETS
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 sessions of educational program). Researchers will compare the experimental group to the other two groups to see if a digital therapeutic solution integrating a multidimensional dance-based program and motivational system is effective in increasing adherence to rehabilitation treatment.
Who can take part
Inclusion criteria
- age between 18 and 85 years (adult and older adult);
- education equal to or more than five years
- agreement to participate with the signature of the informed consent form;
- 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
- Normal score to a screening test for cognitive impairment (Montreal Cognitive Assessment test - MoCA test \> 15.5 Santangelo et al., 2015)
Exclusion criteria
- 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)
- presence of overt hearing/visual impairment
- for the MCI group, the absence of a caregiver/study partner able to support the participant;
- no living in one's own home;
- for the MS group, score in cerebellum function at EDSS greater than 3
Where it is running
3 locations listed.
- 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