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

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.

NCT Number	NCT06112639
Lead Sponsor	Fondazione Don Carlo Gnocchi ETS Collaborators: IRCCS Centro San Giovanni di Dio Fatebenefratelli, University of Milano Bicocca, IRCCS Centro Neurolesi Bonino Pulejo
Conditions	Sclerosis, Multiple, Neurocognitive Impairment, Mild, Neurocognitive Dysfunction
Enrollment	192 participants
Start Date	2024-01-31
Primary Completion	2025-05-01 (estimated)
Study Completion	2025-10-31 (estimated)
Updated on ClinicalTrials.gov	2025-01-10