The effectiveness of combining a home-based Digital motor Telerehabilitation program with conventional therapy in progressive multiple sclerosis: A study protocol for a multicenter, randomized controlled trial
Objective The primary aim is to evaluate the effectiveness of in-hospital rehabilitation followed by a home-based Digital Telerehabilitation program on mobility versus in-hospital rehabilitation alone in patients with Progressive Multiple Sclerosis. Secondary aims are the intervention's impact...
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2025-07-01
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| Series: | Digital Health |
| Online Access: | https://doi.org/10.1177/20552076251323995 |
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| author | Marialuisa Gandolfi Mauro Crestani Gabriele Perachiotti Francesca Salaorni Andrea Baroni Alberto Gajofatto Riccardo Orlandi Michela Rimondini Valeria Donisi Stefano Landi Giovanni Morone Mirta Fiorio Irene Lozzi Nicola Valè Ilaria Siviero Silvia Francesca Storti Nicola Smania Sofia Straudi |
| author_facet | Marialuisa Gandolfi Mauro Crestani Gabriele Perachiotti Francesca Salaorni Andrea Baroni Alberto Gajofatto Riccardo Orlandi Michela Rimondini Valeria Donisi Stefano Landi Giovanni Morone Mirta Fiorio Irene Lozzi Nicola Valè Ilaria Siviero Silvia Francesca Storti Nicola Smania Sofia Straudi |
| author_sort | Marialuisa Gandolfi |
| collection | DOAJ |
| description | Objective The primary aim is to evaluate the effectiveness of in-hospital rehabilitation followed by a home-based Digital Telerehabilitation program on mobility versus in-hospital rehabilitation alone in patients with Progressive Multiple Sclerosis. Secondary aims are the intervention's impact on clinical, physiological, psychological, and economic outcomes. Methods This multicenter, single-blind, randomized controlled trial will involve 78 participants with Progressive Multiple Sclerosis. All participants will complete 10 in-hospital rehabilitation sessions (1 hour/day, three days/week). The experimental group will receive an additional 12-week home-based Digital Telerehabilitation (3 sessions/week), while the control group general self-management instructions. Based on primary and secondary outcomes, a blinded rater will evaluate participants before and after rehabilitation and at 12 and 24 weeks follow-up. Results Integrating home-based Digital Telerehabilitation is expected to mitigate the progression of disability, promote self-management, and reduce healthcare costs, offering a cost-effective and accessible solution for managing Progressive Multiple Sclerosis. Conclusions This study will provide essential insights into the role of Digital Telerehabilitation in the hybrid care model to manage Progressive Multiple Sclerosis, with the potential to guide clinical practice and inform health policy. The physiological and economic evaluations will further clarify the benefits and cost-effectiveness of the intervention. Trial registration This trial was registered in ClinicalTrials.gov (NCT06485115; URL: https://clinicaltrials.gov/study/NCT06485115?cond=NCT06485115&rank=1 ). |
| format | Article |
| id | doaj-art-aab9dc0be8ec4ae6a1e216906a37d5dc |
| institution | DOAJ |
| issn | 2055-2076 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Digital Health |
| spelling | doaj-art-aab9dc0be8ec4ae6a1e216906a37d5dc2025-08-20T02:50:08ZengSAGE PublishingDigital Health2055-20762025-07-011110.1177/20552076251323995The effectiveness of combining a home-based Digital motor Telerehabilitation program with conventional therapy in progressive multiple sclerosis: A study protocol for a multicenter, randomized controlled trialMarialuisa Gandolfi0Mauro Crestani1Gabriele Perachiotti2Francesca Salaorni3Andrea Baroni4Alberto Gajofatto5Riccardo Orlandi6Michela Rimondini7Valeria Donisi8Stefano Landi9Giovanni Morone10Mirta Fiorio11Irene Lozzi12Nicola Valè13Ilaria Siviero14Silvia Francesca Storti15Nicola Smania16Sofia Straudi17 Neurorehabilitation Unit, AOUI Verona, Verona, Italy Department of Neurosciences, Biomedicine and Movement Sciences, , Verona, Italy Department of Neuroscience, Ferrara University Hospital, Ferrara, Italy Department of Neurosciences, Biomedicine and Movement Sciences, , Verona, Italy Department of Neuroscience, Ferrara University Hospital, Ferrara, Italy Department of Neurosciences, Biomedicine and Movement Sciences, , Verona, Italy Department of Neurosciences, Biomedicine and Movement Sciences, , Verona, Italy Department of Neurosciences, Biomedicine and Movement Sciences, , Verona, Italy Department of Neurosciences, Biomedicine and Movement Sciences, , Verona, Italy Department of Management, University of Verona, Verona, Italy Department of Life, Health and Environmental Sciences, , L'Aquila, Italy Department of Neurosciences, Biomedicine and Movement Sciences, , Verona, Italy Department of Neurosciences, Biomedicine and Movement Sciences, , Verona, Italy Department of Engineering for Innovation Medicine, , Verona, Italy Department of Computer Science, , Verona, Italy Department of Engineering for Innovation Medicine, , Verona, Italy Neurorehabilitation Unit, AOUI Verona, Verona, Italy Department of Neuroscience, Ferrara University Hospital, Ferrara, ItalyObjective The primary aim is to evaluate the effectiveness of in-hospital rehabilitation followed by a home-based Digital Telerehabilitation program on mobility versus in-hospital rehabilitation alone in patients with Progressive Multiple Sclerosis. Secondary aims are the intervention's impact on clinical, physiological, psychological, and economic outcomes. Methods This multicenter, single-blind, randomized controlled trial will involve 78 participants with Progressive Multiple Sclerosis. All participants will complete 10 in-hospital rehabilitation sessions (1 hour/day, three days/week). The experimental group will receive an additional 12-week home-based Digital Telerehabilitation (3 sessions/week), while the control group general self-management instructions. Based on primary and secondary outcomes, a blinded rater will evaluate participants before and after rehabilitation and at 12 and 24 weeks follow-up. Results Integrating home-based Digital Telerehabilitation is expected to mitigate the progression of disability, promote self-management, and reduce healthcare costs, offering a cost-effective and accessible solution for managing Progressive Multiple Sclerosis. Conclusions This study will provide essential insights into the role of Digital Telerehabilitation in the hybrid care model to manage Progressive Multiple Sclerosis, with the potential to guide clinical practice and inform health policy. The physiological and economic evaluations will further clarify the benefits and cost-effectiveness of the intervention. Trial registration This trial was registered in ClinicalTrials.gov (NCT06485115; URL: https://clinicaltrials.gov/study/NCT06485115?cond=NCT06485115&rank=1 ).https://doi.org/10.1177/20552076251323995 |
| spellingShingle | Marialuisa Gandolfi Mauro Crestani Gabriele Perachiotti Francesca Salaorni Andrea Baroni Alberto Gajofatto Riccardo Orlandi Michela Rimondini Valeria Donisi Stefano Landi Giovanni Morone Mirta Fiorio Irene Lozzi Nicola Valè Ilaria Siviero Silvia Francesca Storti Nicola Smania Sofia Straudi The effectiveness of combining a home-based Digital motor Telerehabilitation program with conventional therapy in progressive multiple sclerosis: A study protocol for a multicenter, randomized controlled trial Digital Health |
| title | The effectiveness of combining a home-based Digital motor Telerehabilitation program with conventional therapy in progressive multiple sclerosis: A study protocol for a multicenter, randomized controlled trial |
| title_full | The effectiveness of combining a home-based Digital motor Telerehabilitation program with conventional therapy in progressive multiple sclerosis: A study protocol for a multicenter, randomized controlled trial |
| title_fullStr | The effectiveness of combining a home-based Digital motor Telerehabilitation program with conventional therapy in progressive multiple sclerosis: A study protocol for a multicenter, randomized controlled trial |
| title_full_unstemmed | The effectiveness of combining a home-based Digital motor Telerehabilitation program with conventional therapy in progressive multiple sclerosis: A study protocol for a multicenter, randomized controlled trial |
| title_short | The effectiveness of combining a home-based Digital motor Telerehabilitation program with conventional therapy in progressive multiple sclerosis: A study protocol for a multicenter, randomized controlled trial |
| title_sort | effectiveness of combining a home based digital motor telerehabilitation program with conventional therapy in progressive multiple sclerosis a study protocol for a multicenter randomized controlled trial |
| url | https://doi.org/10.1177/20552076251323995 |
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