Digital therapeutic program combining dance and music for chronic neurological disorders
DANCE REhabilitation Experience (DANCEREX-DTx): Protocol for a Randomized Controlled Trial on Effectiveness of Digital Therapeutics in Chronic Neurological Disabilities
This study is testing a new dance and music program to see if it can help people with Multiple Sclerosis and early signs of cognitive decline feel better and improve their daily life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 3 sites (Brescia and 2 other locations) |
| Trial ID | NCT06112639 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy of a new digital therapeutic solution called DANCEREX-DTx, which integrates a multidimensional rehabilitation program based on dance and music with a motivational system. Participants will be randomized into three groups: one receiving the DANCEREX program, another receiving a dance-based program without the motivational component, and a placebo group receiving an educational program. The study will assess adherence, clinical and functional measures, quality of life, and the usability and acceptability of the system among individuals with Multiple Sclerosis and pre-Mild Cognitive Impairment. The trial seeks to provide insights into the potential benefits of dance-based rehabilitation in improving cognitive and functional outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 85 with a diagnosis of Multiple Sclerosis or pre-Mild Cognitive Impairment.
Not a fit: Patients with comorbidities that hinder participation in a home program, such as severe balance issues or a history of falls, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the quality of life and cognitive function for patients with chronic neurological disorders.
How similar studies have performed: While the specific approach of combining dance and music in a digital therapeutic context is novel, similar rehabilitation methods have shown promise in improving outcomes for patients with neurological conditions.
Eligibility criteria
Show full 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
Where this trial is running
Brescia and 2 other locations
- IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli — Brescia, Italy (Recruiting)
- IRCCS Centro Neurolesi Bonino-Pulejo — Messina, Italy (Recruiting)
- IRCCS Fondazione Don Carlo Gnocchi ONLUS — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Maria Pia Amato — IRCCS Fondazione Don Carlo Gnocchi ONLUS
- Study coordinator: Francesca Baglio, MD
- Email: fbaglio@dongnocchi.it
- Phone: +390240308952
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.