DANCE Rehabilitation EXperience (DANCEREX-DTx): Protocol for a randomized controlled trial on effectiveness of digital therapeutics in chronic neurological disabilities

Abstract

Objective

Rehabilitation is an important player in preventing and reducing the high impact of disability on everyday functioning in chronic neurological diseases (CNDs), especially if timely, intensive, and multidimensional. However, to date, rehabilitation is often a service accessible only to a few people, and the issue of a progressive decrease in treatment adherence still remains to be addressed. This study protocol describes an RCT whose aim is to test the effectiveness in terms of adherence of DANCE Rehabilitation EXperience (DANCEREX-DTx), a new digital therapeutic solution which combines a holistic, multidimensional program based on dance and music with an innovative motivational system.

Methods

The randomized, single-blind, controlled trial will involve 192 patients with CNDs from three rehabilitation centers in Italy. Participants will be randomized (with an allocation ratio of 2:2:1) into three interventions: (1) DANCEREX treatment, (2) multidimensional dance-based program, and (3) educational program. Groups will be assessed at the baseline (T0), after intervention (T1—after 12 weeks), and after six months from enrollment (T2). The primary outcome will be treatment adherence in terms of the number of drop-outs and the percentage of attended sessions on the total prescribed. Moreover, a multifaceted evaluation, including quality of life and clinical/functional measures, will be conducted at each time-point. Surrogate measures (neuroimaging and neurobiological) will be collected at T0 and T1. Finally, usability and acceptability will be assessed at T1.

Results

We expect the validation, in terms of usability, acceptability, and effectiveness of DANCEREX-DTx as an innovative rehabilitation program able to respond in a sustainable way to the great need for rehabilitation of people with CNDs.

Conclusion

With DANCEREX-DTx, we aspire to change the hospital-centered paradigm of rehabilitation care to bring it to the patients' homes, making them active in their treatment path and promoting motivation and adherence to treatment from the initial stages of the disease.

Trial registration: The trial was registered in the clinicaltrials.gov database (identifier NCT06112639) on 2023-11-01.