The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders

Official title

DANCE REhabilitation Experience (DANCEREX-DTx): Protocol for a Randomized Controlled Trial on Effectiveness of Digital Therapeutics in Chronic Neurological Disabilities

Overview

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.

Interventions

• Device DANCEREX-DTx
  DANCEREX treatment integrates the dance activities with an innovative motivational system into applied game The patients will perform the exercises (different dance styles, i.e., Irish Dance, Hip Hop, Cha Cha Cha) independently at home using videos that illustrate the activity to be performed for each treatment session on a mobile device (tablet). The intensity of the exercise will be moderate with a progressive increase in difficulty level over the weeks. The treatment will start with simple d
• Device Multidimensional dance-based program
  Multidimensional dance-based program provided via a digital medicine telerehabilitation platform. The patient will perform the exercises (different dance styles, i.e., Irish Dance, Hip Hop, Cha Cha Cha) independently at home using videos that illustrate the activity to be performed for each treatment session on a mobile device (tablet). The intensity of the exercise will be moderate with a progressive increase in difficulty level over the weeks. The treatment will start with simple dance movemen
• Device Educational Program
  Subjects will view educational/informative videos on Tablet. The treatment will be provided via a digital medicine platform.

Primary outcome measures

• Adherence to treatment [Time frame: 12 weeks of treatment]

Secondary outcome measures (12)

• Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment (MoCA; Conti et al., 2015) [Time frame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)]
• Change in visuoperceptual and attentional abilities measured by Trail Making Test (TMT part-A and part-B; Giovagnoli et al., 1996) [Time frame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)]
• Change in visuoperceptual and attentional abilities measured by Symbol Digit Modalities Test (SDMT; Smith A., 1973; Nocentini U., 2006) [Time frame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)]
• Change in executive functions, including visual attention and inhibitory control of behavior measured by Stroop Test (Caffarra et al., 2002) [Time frame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)]
• Change in Verbal and semantic fluency measured by The Verbal Fluency and Semantic Tests (Carlesimo et al., 1996; Novelli et al., 1986). [Time frame: 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) [Time frame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)]
• Change in long term verbal memory measured by 15-Words of Rey (Carlesimo et al., 1995) [Time frame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)]
• Change in Static and dynamic balance measured by Mini-Best Test (Franchignoni et al., 2010) [Time frame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)]
• Change in Aerobic Capacity and Gait measured by 6' Minute Walking Test (6MWT) [Time frame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)]
• Changes in affect measured by Positive-Negative Affect Schedule (PANAS; Watson et al, 1988) [Time frame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)]
• Changes in Activation level of Patients measured by Patient Activation Measure 13 (PAM13; Hibbard et al., 2004) [Time frame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)]
• Changes in patient's self-rated health measured by EuroQol five dimensions (5D) and five levels (5L) (The EuroQol Group, 1990; Janssen et al.,2013) [Time frame: Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Italy · 3 centers

• IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli — Brescia
• IRCCS Centro Neurolesi Bonino-Pulejo — Messina
• IRCCS Fondazione Don Carlo Gnocchi ONLUS — Milan

Publications

• Borgnis F, Blasi V, Realdon O, Mantovani F, Cotelli M, Manenti R, Campana E, Lo Buono V, Marino S, Mavrodiev PA, Saresella M, Trimarchi PD, Alberoni M, Amato MP, Baglio F. DANCE Rehabilitation EXperience (DANCEREX-DTx): Protocol for a randomized controlled trial on effectiveness of digital therapeutics in chronic neurological disabilities. Digit Health. 2025 Mar 25;11:20552076251324448. doi: 10.11 PMID 40144043

Identifiers

NCT: NCT06112639 · DANCEREX-DTx

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗