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

NCT06112639 | Recruiting

• 1 other identifier: DANCEREX-DTx
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 3

Brief Summary

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

Sclerosis, Multiple; Neurocognitive Impairment, Mild; Neurocognitive Dysfunction

Keywords

rehabilitation; multiple sclerosis; dementia; digital therapeutics; neurocognitive dysfunction; MRI; neuroinflammation; telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Adherence to treatment

  Adherence to treatment, in terms of both numbers of drop-out and percentage of attended sessions on the total prescribed

  12 weeks of treatment

Secondary Outcomes (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)

• Change 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)

• Change 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)

• Change 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)

• Change 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)

Other Outcomes (7)

• Changes in brain morphometry as detected by Magnetic Resonance Imaging Examination.

  Time Frame: Baseline, post-treatment (up to 12 weeks)

• Changes in structural connectivity as detected by Magnetic Resonance Imaging Examination.

  Time Frame: Baseline, post-treatment (up to 12 weeks)

• Changes in functional connectivity as detected by Magnetic Resonance Imaging Examination.

  Time Frame: Baseline, post-treatment (up to 12 weeks)

Study Arms (3)

DANCEREX Treatment

EXPERIMENTAL

Multidimensional dance-based program with motivational support integrated into applied game. The treatment will last 12 weeks with a frequency of two sessions a week, each lasting about 45 min.

Device: DANCEREX-DTx

Multidimensional dance-based program

ACTIVE COMPARATOR

Multidimensional dance-based program without motivational support. The treatment will last 12 weeks with a frequency of two sessions a week, each lasting about 45 min.

Device: Multidimensional dance-based program

Educational Program

PLACEBO COMPARATOR

Educational/informative videos on managing of clinical conditions.The program will last 12 weeks with a frequency of two sessions a week, each lasting about 45 min.

Device: Educational Program

Interventions

DANCEREX-DTx DEVICE

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 dance movements to be performed in a sitting position to proceed with gradually more complex sequences, always to be performed in safe conditions (first seated and then standing, holding onto a chair). In addition, the DANCEREX app involves a game dynamic in which the execution of the rehabilitation sessions "feeds" a digital book that allows the rehabilitation experience to be placed in a narrative context.

DANCEREX Treatment

Multidimensional dance-based program DEVICE

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 movements to be performed in a sitting position to proceed with gradually more complex sequences, always to be performed in safe conditions (first seated and then standing, holding onto a chair).

Multidimensional dance-based program

Educational Program DEVICE

Subjects will view educational/informative videos on Tablet. The treatment will be provided via a digital medicine platform.

Educational Program

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• IRCCS Centro San Giovanni di Dio Fatebenefratelli: collaborator
• University of Milano Bicocca: collaborator
• IRCCS Centro Neurolesi Bonino Pulejo: collaborator

Study Sites (3)

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

Brescia, 25125, Italy

RECRUITING

IRCCS Centro Neurolesi Bonino-Pulejo

Messina, 98124, Italy

RECRUITING

IRCCS Fondazione Don Carlo Gnocchi ONLUS

Milan, 20148, Italy

RECRUITING

Related Publications (1)

• 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: 10.1177/20552076251324448. eCollection 2025 Jan-Dec.

  PMID: 40144043 DERIVED

Related Links

• internet page of Institution
• internet page of Research Unit

MeSH Terms

Conditions

Multiple Sclerosis; Lymphoma, Follicular; Cognition Disorders; Dementia; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Pia Amato

  IRCCS Fondazione Don Carlo Gnocchi ONLUS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Baglio, MD

CONTACT

+390240308952; fbaglio@dongnocchi.it

Francesca Borgnis, PhD

CONTACT

+390240308952; fborgnis@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 1, 2023
• Study Start: January 31, 2024
• Primary Completion: May 1, 2025
• Study Completion: October 31, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

IT (3)