The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders
DANCE REhabilitation Experience (DANCEREX-DTx): Protocol for a Randomized Controlled Trial on Effectiveness of Digital Therapeutics in Chronic Neurological Disabilities
What it found
No result yet.
What was tested
Treatment tested
- DANCEREX-DTx
Compared with
- Multidimensional dance-based program
Placebo
- Educational Program
What it measured
Main measures
Adherence to treatment
12 weeks of treatment
Quality of life (reported by participants)
Other measures (16)
Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment (MoCA; Conti et al., 2015)
Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
Thinking and memoryChange in visuoperceptual and attentional abilities measured by Trail Making Test (TMT part-A and part-B; Giovagnoli et al., 1996)
Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
Thinking and memoryChange in visuoperceptual and attentional abilities measured by Symbol Digit Modalities Test (SDMT; Smith A., 1973; Nocentini U., 2006)
Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
Thinking and memoryChange in executive functions, including visual attention and inhibitory control of behavior measured by Stroop Test (Caffarra et al., 2002)
Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
Thinking and memoryChange in Verbal and semantic fluency measured by The Verbal Fluency and Semantic Tests (Carlesimo et al., 1996; Novelli et al., 1986).
Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
Change in long term visual memory measured by Free and Cued Selective Reminding Test (FCSRT) (Frasson et al., 2011)
Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
Thinking and memoryChange in long term verbal memory measured by 15-Words of Rey (Carlesimo et al., 1995)
Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
Thinking and memoryChange in Static and dynamic balance measured by Mini-Best Test (Franchignoni et al., 2010)
Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
Walking and mobilityChange in Aerobic Capacity and Gait measured by 6' Minute Walking Test (6MWT)
Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
Walking and mobilityPhysical functionChanges in affect measured by Positive-Negative Affect Schedule (PANAS; Watson et al, 1988)
Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)
Mood and sleep
Who could take part
MS (type not specified) · 18 to 85
Show the full criteria
Inclusion criteria
1. age between 18 and 85 years (adult and older adult); 2. education equal to or more than five years 3. agreement to participate with the signature of the informed consent form; 4. 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 5. Normal score to a screening test for cognitive impairment (Montreal Cognitive Assessment test - MoCA test > 15.5 Santangelo et al., 2015)
Exclusion criteria
1. 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) 2. presence of overt hearing/visual impairment 3. for the MCI group, the absence of a caregiver/study partner able to support the participant; 4. no living in one's own home; 5. for the MS group, score in cerebellum function at EDSS greater than 3
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
Papers
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History
Started
Jan 2024
Main results due
May 2025
Finished
Oct 2025