Actively Recruiting
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-01-10
192
Participants Needed
3
Research Sites
26 weeks
Total Duration
F
Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
I
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Collaborating Sponsor
Researchers are evaluating a new digital therapeutic solution called DANCEREX-DTx for people with chronic neurological disorders like Multiple Sclerosis and early signs of Mild Cognitive Impairment or risk of Alzheimer's Disease. The study aims to test if this combined dance and music rehabilitation program with a motivational system improves treatment adherence, clinical and functional outcomes, quality of life, and usability compared to standard dance programs or educational sessions. Participants will be randomly assigned to one of three groups: the experimental group using DANCEREX-DTx with 24 dance-based sessions supported by a motivational game system, an active comparator group receiving the same 24 dance sessions without the motivational system, or a placebo group watching educational videos. Each group will follow a 12-week program with two 45-minute sessions per week delivered via a tablet at home, progressing from seated to standing dance movements. During the study, researchers will monitor treatment adherence over the 12 weeks and assess various cognitive functions, balance, aerobic capacity, mood, health status, fatigue, depression, and anxiety at the start, after treatment, and up to six months later. Participants will complete tests like the Montreal Cognitive Assessment, Trail Making Test, and 6-Minute Walking Test. The study also tracks quality of life and motivation levels to evaluate the overall impact and acceptability of the digital rehabilitation approach.
CONDITIONS
The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants perform dance-based exercises or view educational videos independently at home using a digital medicine platform. The treatment includes different dance styles with progressively increasing difficulty and motivational support depending on the assigned group.
Two sessions per week, each lasting about 45 minutes
Duration - Up to 6 months
Participants are assessed for changes in cognitive function, balance, aerobic capacity, mood, and self-rated health up to 6 months from baseline after completing the treatment.
1 to 2 visits depending on assessments
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
F
Francesca Baglio, MD
F
Francesca Borgnis, PhD
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Francesca Borgnis, Valeria Blasi, Olivia Realdon...
https://pubmed.ncbi.nlm.nih.gov/40144043