DANCE REhabilitation Experience (DANCEREX-DTx): Protocol for a Randomized Controlled Trial on Effectiveness of Digital Therapeutics in Chronic Neurological Disabilities

Fondazione Don Carlo Gnocchi Onlus3 sites in 1 country192 target enrollmentJanuary 31, 2024

ConditionsSclerosis, Multiple Neurocognitive Impairment, Mild Neurocognitive Dysfunction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sclerosis, Multiple
Sponsor: Fondazione Don Carlo Gnocchi Onlus
Enrollment: 192
Locations: 3
Primary Endpoint: Adherence to treatment
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 31, 2024

End Date

October 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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)

Exclusion Criteria

•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;
•for the MS group, score in cerebellum function at EDSS greater than 3

Outcomes

Primary Outcomes

Adherence to treatment

Time Frame: 12 weeks of treatment

Adherence to treatment, in terms of both numbers of drop-out and percentage of attended sessions on the total prescribed

Secondary Outcomes

Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment (MoCA; Conti et al., 2015)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
Change in visuoperceptual and attentional abilities measured by Trail Making Test (TMT part-A and part-B; Giovagnoli et al., 1996)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
Change in visuoperceptual and attentional abilities measured by Symbol Digit Modalities Test (SDMT; Smith A., 1973; Nocentini U., 2006)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
Change in executive functions, including visual attention and inhibitory control of behavior measured by Stroop Test (Caffarra et al., 2002)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
Change in Verbal and semantic fluency measured by The Verbal Fluency and Semantic Tests (Carlesimo et al., 1996; Novelli et al., 1986).(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
Change in long term visual memory measured by Free and Cued Selective Reminding Test (FCSRT) (Frasson et al., 2011)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
Change in long term verbal memory measured by 15-Words of Rey (Carlesimo et al., 1995)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
Change in Static and dynamic balance measured by Mini-Best Test (Franchignoni et al., 2010)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
Change in Aerobic Capacity and Gait measured by 6' Minute Walking Test (6MWT)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
Changes in affect measured by Positive-Negative Affect Schedule (PANAS; Watson et al, 1988)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
Changes in Activation level of Patients measured by Patient Activation Measure 13 (PAM13; Hibbard et al., 2004)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
Changes in patient's self-rated health measured by EuroQol five dimensions (5D) and five levels (5L) (The EuroQol Group, 1990; Janssen et al.,2013)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
Changes in patient's self-rated health status measured by Short Form Health Survey 36 (SF36; Ware, 2000)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
Changes in patient's fatigue measured by Modified Fatigue Index Scale (MFIS; Kos et al., 2006)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
Changes in depressive symptoms measured by Beck Depression Inventory for Primary Care (BDI-PC, Steer et al., 1999)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))
Changes in anxiety level measured by State-Trait Anxiety Inventory - Form Y (STAI - Y; Spielberger, 1983; Pedrabissi & Santinello, 1989)(Baseline, post-treatment (up to 12 weeks) and follow-up (up to 6 months from the baseline))