ClearSpeechTogether versus standard NHS speech intervention: Study protocol for a single, mixed method, rater blinded pilot randomised controlled trial for people living with MSA-C

Abstract Background: Speech and communication problems are a common symptom of cerebellar Multiple System Atrophy (MSA-C). While recent studies have suggested that these patients can benefit from speech therapy, no properly controlled, large scale investigation of effectiveness has been conducted to date. Furthermore, studies have not focused on how novel, often workload intensive approaches compare to existing standard care. The aim of the current project is to establish feasibility and acceptability of a intensive, mixed individual / group, peer supported speech therapy approach (ClearSpeechTogether) in a group of patients with MSA-C, and to pilot a two-arm RCT comparing it to standard individual therapy. Methods: This protocol outlines a pilot study for a mixed-method registered controlled trial. 24 patients will be allocated in a 1:1 ratio to either existing speech \& language therapy provision or ClearSpeechTogether. Two pre-therapy speech assessments will be carried out followed by 6 weeks of therapy, a post-therapy assessment and a follow-up assessment after 8 weeks. These assessments will evaluate physiological functioning, impairment and participation. Three qualitative interviews will also be conducted at pre, post and follow-up to investigate patients' experiences of the interventions. Discussion: Demonstrating acceptability, feasibility and communication benefits in the current pilot would set the basis for a larger registered controlled trial. If indications of additional benefits of ClearSpeechTogether over existing provisions are found a full superiority trial would be conducted. Trial registration: ISRCTN, ISRCTN44652664. Registered 16 December 2022, https://www.isrctn.com/ISRCTN44652664