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NCT06112639: DANCEREX-DTx
The DANCEREX Proof-of-Concept Study for Chronic Neurological Disorders
NA trial testing DANCEREX-DTx in Sclerosis, Multiple in 192 participants. Currently enrolling.
1 May 2025
Quick facts
| Lead sponsor | Fondazione Don Carlo Gnocchi Onlus |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 192 |
| Start date | 31 January 2024 |
| Primary completion | 1 May 2025 |
| Estimated completion | 31 October 2025 |
| Sites | 3 locations across Italy |
Drugs / interventions tested
- DANCEREX-DTx
- Multidimensional dance-based program
- Educational Program
Conditions studied
- Sclerosis, Multiple — all drugs for Sclerosis, Multiple →
- Neurocognitive Impairment, Mild — all drugs for Neurocognitive Impairment, Mild →
- Neurocognitive Dysfunction — all drugs for Neurocognitive Dysfunction →
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):
-
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:
- PubMed search for NCT06112639
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Sclerosis, Multiple
Currently open trials in the same condition.
- NCT06428201 — The Efficacy of Tele Rehabilitation- Based Task-Specific Training for Cognitive Function Improvement · NA · active not recruiting
- NCT05857280 — EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis (EXOSEP 2) · NA · recruiting
- NCT03900221 — French Registry for Monitoring Pregnancies for Multiple Sclerosis · recruiting
- NCT03600779 — Application of ihMT MRI in Multiple Sclerosis · NA · recruiting
Other Fondazione Don Carlo Gnocchi Onlus trials
Trials by the same sponsor.
- NCT07252856 — Transcultural Digital Solutions in Phase III Cardiac Rehabilitation · NA · not yet recruiting
- NCT07290218 — Tridimensional Robotic Assessment of Neglect in Brain Injured Patients · not yet recruiting
- NCT07064226 — Validation of a Digital Intervention to Rehabilitate Cognitive Resources · NA · recruiting
- NCT07130929 — Functional Electrical Stimulation to Treat Critical Neuromyopathy After Severe Stroke: a Pilot Study. · NA · recruiting
- NCT07159854 — Telerehabilitation in Central and Peripheral Neurological Sequelae From Chemotherapy · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06112639 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Don Carlo Gnocchi Onlus
- Last refreshed: 10 January 2025
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