Evaluating DANCEREX Digital Dance Therapy for Adults with Multiple Sclerosis or Mild Cognitive Impairment
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-01-10
192
Participants Needed
3
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
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 Alzheimers 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
Brief Title
The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders
Research Team
F
Francesca Baglio, MD
F
Francesca Borgnis, PhD
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Agreement to participate with signed informed consent
Clinical diagnosis of Multiple Sclerosis with EDSS score 4.5 or less, relapsing-remitting course, no recent relapses or steroids for at least one month, OR diagnosis of pre-Mild Cognitive Impairment or MCI at risk of Alzheimer's with Clinical Dementia Rating 0.5 or less
Normal cognitive screening score (Montreal Cognitive Assessment test over 15.5)
You will not qualify if you...
Comorbidities preventing safe home exercise (e.g., balance problems, history of falls in past 6 months, use of walking aids)
Significant hearing or vision impairment
For MCI group, lack of caregiver or study partner support
Not living in own home
For MS group, cerebellum function score at EDSS greater than 3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
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
Follow-up
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
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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Evaluating DANCEREX Digital Dance Therapy for Adults with Multiple Sclerosis or Mild Cognitive Impairment
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Published Research Related To This Trial
DANCE Rehabilitation EXperience (DANCEREX-DTx): Protocol for a randomized controlled trial on effectiveness of digital therapeutics in chronic neurological disabilities.