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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 85 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06112639
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fondazione Don Carlo Gnocchi Onlus
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Maria Pia Amato
Principal Investigator Affiliation	IRCCS Fondazione Don Carlo Gnocchi ONLUS
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sclerosis, Multiple, Neurocognitive Impairment, Mild, Neurocognitive Dysfunction
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: DANCEREX Treatment

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.

Active Comparator: Multidimensional dance-based program

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.

Placebo Comparator: Educational Program

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.

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 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.

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 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).

Device: - Educational Program

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Brescia 3181554, Italy

Status

Recruiting

Address

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

Brescia 3181554, , 25125

Site Contact

Maria Cotelli, PhD

[email protected]

+390303501457

IRCCS Centro Neurolesi Bonino-Pulejo, Messina 2524170, Italy

Status

Recruiting

Address

IRCCS Centro Neurolesi Bonino-Pulejo

Messina 2524170, , 98124

Site Contact

Viviana Lo Buono

[email protected]

+3909060128185

IRCCS Fondazione Don Carlo Gnocchi ONLUS, Milan 3173435, Italy

Status

Recruiting

Address

IRCCS Fondazione Don Carlo Gnocchi ONLUS

Milan 3173435, , 20148

Site Contact

Francesca Baglio, MD

[email protected]

+390240308951

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