1. Telerehabilitation for Lee Silverman Voice Treatment (Tele-LSVT)-Loud on voice intensity and voice use in daily living in people with multiple sclerosis: A protocol for a feasibility and pilot randomized controlled study
- Author
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Vitali, C, Fusari, G, Baldanzi, C, Cacciatore, D, Crispiatico, V, Carullo, A, Rovaris, M, Cattaneo, D, Baglio, F, Isernia, S, Vitali, Chiara, Fusari, Giulia, Baldanzi, Cinzia, Cacciatore, Diego Michael, Crispiatico, Valeria, Carullo, Alessio, Rovaris, Marco, Cattaneo, Davide, Baglio, Francesca, Isernia, Sara, Vitali, C, Fusari, G, Baldanzi, C, Cacciatore, D, Crispiatico, V, Carullo, A, Rovaris, M, Cattaneo, D, Baglio, F, Isernia, S, Vitali, Chiara, Fusari, Giulia, Baldanzi, Cinzia, Cacciatore, Diego Michael, Crispiatico, Valeria, Carullo, Alessio, Rovaris, Marco, Cattaneo, Davide, Baglio, Francesca, and Isernia, Sara
- Abstract
Objective: Alterations in voice intensity and quality may constitute a social life limitation in people with multiple sclerosis (MS), but only 2% of cases receive speech therapy. Especially the Lee Silverman Voice Treatment (LSVT)-Loud is a highly effective intensive method for voice intensity, requiring subjects’ repeated attendance at the clinic. Telerehabilitation may represent a feasible solution to bypass potential barriers related to speech therapy attendance, scaling up the beneficial effects of the treatment to a broader population. The proposed protocol aims to test the feasibility and the pilot efficacy of the LSVT-Loud delivered in telerehabilitation (Tele-LSVT-Loud), compared to the same treatment delivered in the clinic (LSVT-Loud). Methods: A single-blinded, parallel, two-arm, pilot randomized (1:1 ratio) controlled trial will be performed involving 20 people with MS. Patients will be allocated to 4 weeks of Tele-LSVT-Loud by accessing a telerehabilitation platform at home or LSVT-Loud conventionally delivered in the clinic. Feasibility and pilot effectiveness will be evaluated three times: before (T0), after the treatment (T1), and 3-month follow-up (T2). Feasibility measures will include adherence, adverse events, user experience, motivation, engagement, and acceptability. Vocal intensity during a 1-minute monologue will be the primary outcome measure. Secondary outcome measures will be the vocal quality during a 1-minute monologue, sustained /a/ voice intensity, quality and stability, voice use in daily life, voice subjective perception in daily life, and quality of life. Results: Expected results will be (1) high feasibility of Tele-LSVT-Loud and (2) a non-inferiority effect of Tele-LSVT-Loud compared with face-to-face treatment delivery on voice intensity and quality outcomes. Conclusions: Tele-LSVT-Loud may be a feasible intervention for MS alteration in voice intensity and quality with a non-inferior effect compared to LSVT-Loud.
- Published
- 2023