The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorFondazione Don Carlo Gnocchi Onlus
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
for the MCI group, the absence of a caregiver/study partner able to support the participant;
no living in one's own home;
Trial design
Design model
Parallel
Treatments tested in this trial
DANCEREX-DTx
DeviceDANCEREX 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.
Multidimensional dance-based program
DeviceMultidimensional 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).
Educational Program
DeviceSubjects will view educational/informative videos on Tablet. The treatment will be provided via a digital medicine platform.
Treatment groups
192 Participants
are divided into 3 treatment groupsGroup A: DANCEREX TreatmentExperimental treatment 1 intervention
Group B: Multidimensional dance-based programActive comparator 1 intervention
Group C: Educational ProgramPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adherence to treatment
Adherence to treatment, in terms of both numbers of drop-out and percentage of attended sessions on the total prescribed
Time frame
12 weeks of treatmentSecondary outcomes
1
Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment (MoCA; Conti et al., 2015)
MoCA is a screening test for global cognitive functioning. It includes tasks involving several domains: visuospatial/executive function tests, naming, selective and sustained attention, language, abstraction, memory and orientation. High scores are indicative of better general cognitive performance.
Time frame
Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)2
Change in visuoperceptual and attentional abilities measured by Trail Making Test (TMT part-A and part-B; Giovagnoli et al., 1996)
TMT is a neuropsychological test that involves visual scanning (TMT-A) and dual-task (TMT-B). The TMT is scored by how long it takes to complete each part of the test. High execution times indicate poor performance.
Time frame
Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)3
Change in visuoperceptual and attentional abilities measured by Symbol Digit Modalities Test (SDMT; Smith A., 1973; Nocentini U., 2006)
This paper-pencil measure involves a substitution task using a coding key with nine different abstract symbols, each paired with a numeral. Below the key, a series of these symbols is presented, and the participant is asked to say the corresponding number for each symbol. The score consists of the number of correct substitutions within 90 seconds. Higher scores indicate better performance.
Time frame
Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)4
Change in executive functions, including visual attention and inhibitory control of behavior measured by Stroop Test (Caffarra et al., 2002)
The test consists of three consecutive parts that the subject must perform as quickly and accurately as possible: 1) read a list of color names on a sheet; 2) say the names of the colors of some colored spots on the sheet; 3) name the color of the ink with which the names of the colors were written. Two scores are calculated by summing the number of errors made and the time taken to complete all parts. High execution times and the number of errors indicate poor performance.
Time frame
Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline)Other outcomes
1
Changes in brain morphometry as detected by Magnetic Resonance Imaging Examination.
T1weighted 3D images will be collected to test changes in brain morphometry
Time frame
Time Frame: Baseline, post-treatment (up to 12 weeks)2
Changes in structural connectivity as detected by Magnetic Resonance Imaging Examination.
DWI sequences will be collected to detect changes in structural connectivity
Time frame
Time Frame: Baseline, post-treatment (up to 12 weeks)3
Changes in functional connectivity as detected by Magnetic Resonance Imaging Examination.
Resting-State fMRI (Multi echo - Multi-Band) images will be collected for the assessment of brain activity at rest and functional connectivity.
Time frame
Time Frame: Baseline, post-treatment (up to 12 weeks)4
Changes in inflammatory and anti-inflammatory cytokines as measured by blood sampling
The sera will be collected, centrifuged, stored, frozen at -80 C degrees, and shipped (when necessary) to the chosen sample-processing center. The serum will be used to measure by Enzyme-Linked ImmunoSorbent Assay (ELISA) and by Automated Immunoassay System (ELLA) the Inflammatory cytokines (TNF, IL1beta, TGF-beta, IL-6, IL-33, IL-8), and Anti-inflammatory cytokines (IL-10, IL-37),
Time frame
Time Frame: Baseline, post-treatment (up to 12 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Collaborator
University of Milano Bicocca
Collaborator
IRCCS Centro Neurolesi Bonino Pulejo
Collaborator
Source ClinicalTrials.gov