Status:
RECRUITING
The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsors:
IRCCS Centro San Giovanni di Dio Fatebenefratelli
University of Milano Bicocca
Conditions:
Sclerosis, Multiple
Neurocognitive Impairment, Mild
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 motivationa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT06112639
Start Date
January 31 2024
End Date
October 31 2025
Last Update
January 10 2025
Active Locations (3)
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1
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy, 25125
2
IRCCS Centro Neurolesi Bonino-Pulejo
Messina, Italy, 98124
3
IRCCS Fondazione Don Carlo Gnocchi ONLUS
Milan, Italy, 20148