RecruitingNot ApplicableNCT06112639

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

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Enrollment

192 participants

Start Date

Jan 31, 2024

Study Type

INTERVENTIONAL

Conditions

Sclerosis, Multiple Neurocognitive Impairment, Mild Neurocognitive Dysfunction

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This proof-of-concept study (DANCEREX) tests whether a structured home-based dance and exercise program improves physical and cognitive function in people with early multiple sclerosis (MS) or mild cognitive impairment (MCI), which can be an early sign of Alzheimer's disease. **You may be eligible if...** - You are between 18 and 85 years old - You have at least 5 years of education - You have been diagnosed with relapsing-remitting multiple sclerosis (with mild disability, EDSS ≤ 4.5) and have been relapse-free and off steroids for at least one month, OR - You have been diagnosed with pre-MCI, subjective cognitive complaints, or MCI at possible risk of Alzheimer's disease (CDR ≤ 0.5) - You passed a basic cognitive screening test (MoCA > 15.5) **You may NOT be eligible if...** - You have balance problems, a history of falls in the last 6 months, or use assistive devices to walk - You have significant vision or hearing impairment - You do not have a caregiver available (for the MCI group) - You do not live in your own home - Your MS has significant cerebellar (balance/coordination) involvement Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEDANCEREX-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.

DEVICEMultidimensional 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).

DEVICEEducational Program

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