NCT06112639Recruiting
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
Source: ClinicalTrials.gov · Last updated 10 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 192 (estimated)
- First submitted
- 23 Oct 2023
- Start date
- 31 Jan 2024
- Primary completion date
- 1 May 2025
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Diseases
- Multiple sclerosis
- NCT number
- NCT06112639
What you commit to
- Study type: Interventional
- Planned participants: 192
- From 31 Jan 2024 to the primary completion date, 1 May 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| IRCCS Centro Neurolesi Bonino Pulejo Coordinator of this site? Confirm its status | Messina | Italy | Recruiting |
| IRCCS Fondazione Don Carlo Gnocchi ONLUS Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.