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NCT06112639: DANCEREX-DTx

The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders

Recruiting now NA Last updated 10 January 2025
What this trial tests

NA trial testing DANCEREX-DTx in Sclerosis, Multiple in 192 participants. Currently enrolling.

Timeline
31 January 2024
Primary endpoint
1 May 2025
31 October 2025

Quick facts

Lead sponsorFondazione Don Carlo Gnocchi Onlus
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment192
Start date31 January 2024
Primary completion1 May 2025
Estimated completion31 October 2025
Sites3 locations across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Fondazione Don Carlo Gnocchi Onlus — full company profile →

Who can join

Adults 18 to 85, any sex, with Sclerosis, Multiple or Neurocognitive Impairment, Mild. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. DANCE Rehabilitation EXperience (DANCEREX-DTx): Protocol for a randomized controlled trial on effectiveness of digital therapeutics in chronic neurological disabilities.
    Borgnis F, Blasi V, Realdon O, Mantovani F, et al · · 2025 · PMID 40144043 · DOI 10.1177/20552076251324448

Verify or expand the search:

Other recruiting trials for Sclerosis, Multiple

Currently open trials in the same condition.

Other Fondazione Don Carlo Gnocchi Onlus trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06112639.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing