The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders (DANCEREX-DTx)

Don Carlo Gnocchi Onlus Foundation

Status: Enrolling

Conditions: Neurocognitive Impairment, Mild; Sclerosis, Multiple; Neurocognitive Dysfunction

Treatments: Device: Educational Program; Device: Multidimensional dance-based program; Device: DANCEREX-DTx

Study type: Interventional

Funder types: Other

Identifiers

NCT06112639

DANCEREX-DTx

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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192 participants in 3 patient groups, including a placebo group

DANCEREX Treatment

Experimental group

Description:

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.

Treatment:

Device: DANCEREX-DTx

Multidimensional dance-based program

Active Comparator group

Description:

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.

Treatment:

Device: Multidimensional dance-based program

Educational Program

Placebo Comparator group

Description:

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.

Treatment:

Device: Educational Program