Actively Recruiting
The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-01-10
192
Participants Needed
3
Research Sites
91 weeks
Total Duration
On this page
Sponsors
F
Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
I
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- At least five years of education
- Signed informed consent to participate
- Clinical diagnosis of Multiple Sclerosis with EDSS score 4.5 or less, relapsing-remitting course, no relapses or steroid treatment for at least one month, OR diagnosis of pre-Mild Cognitive Impairment/MCI at risk of Alzheimer's with Clinical Dementia Rating 0.5 or less
- Normal cognitive screening score (Montreal Cognitive Assessment test > 15.5)
You will not qualify if you...
- Comorbidities preventing safe home exercise (e.g., balance problems, falls in past 6 months, use of walking aids)
- Significant hearing or visual impairments
- For MCI group, lack of a caregiver or study partner to support the participant
- Not living in own home
- For MS group, cerebellum function score at EDSS greater than 3
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy, 25125
Actively Recruiting
2
IRCCS Centro Neurolesi Bonino-Pulejo
Messina, Italy, 98124
Actively Recruiting
3
IRCCS Fondazione Don Carlo Gnocchi ONLUS
Milan, Italy, 20148
Actively Recruiting
Research Team
F
Francesca Baglio, MD
CONTACT
F
Francesca Borgnis, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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