The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorFondazione Don Carlo Gnocchi Onlus
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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;
Trial design
Treatments tested in this trial
- DANCEREX-DTx
- Multidimensional dance-based program
- Educational Program
Treatment groups
192 Participants
are divided into 3 treatment groupsSponsors and collaborators
Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Collaborator
University of Milano Bicocca
Collaborator
IRCCS Centro Neurolesi Bonino Pulejo
Collaborator
Source ClinicalTrials.gov