ClearSpeechTogether versus standard SLT: a pilot randomised controlled trial for people with MSA-C

Background Speech problems are an early and disabling feature of both variants of MSA. They range from harsh and quiet voice and articulation difficulties characterising the Parkinsonian variant to issues of control resulting in irregular motion and uncontrolled pitch and loudness variations in the cerebellar variant. Both types often also show signs of spasticity, resulting in slow and effortful speech production. Effective communication is important for conveying our immediate needs as well as for building and maintaining social relationships. Speech difficulties can therefore have significant impact on people’s quality of life, frequently leading to social withdrawal and poor mental health.
Despite the prevalence of dysarthria in MSA, there has been a lack of clinical intervention trials designed to improve speech. This is particularly true for ataxic speech problems, as opposed to Parkinsonian symptoms which have been investigated much more widely. However, a number of trials have recently been reported that focused on people with MSA-C. While these studies suggest that these patients can benefit from speech therapy, no properly controlled, large scale investigation of effectiveness has been conducted to date. Outcome measures are often incomplete, only focusing on specific speech features, and no qualitative data on acceptability has been reported to date. Furthermore, studies have not focused on how novel, often workload intensive approaches compare to existing standard care. We recently developed a novel speech intervention (ClearSpeechTogether) that provides intensive, mixed individual / group intervention and is distinct to other approaches in its use of peer supported group session which minimises clinician input whilst maximising patient opportunity for practice and therapeutic gain. Data to date indicates that it can result in speech improvements as well as improved confidence and communication participation. The aim of the current project is to establish feasibility and acceptability of ClearSpeechTogether in a different patient group, i.e. patients with MSA-C, and to pilot a two-arm RCT comparing it to standard SLT provision.
Methods: 24 patients with clinically probably MSA-C and mild to moderate dysarthria were recruited from the Sheffield Ataxia Centre in the UK between April 2023 and January 2024, and allocated in a 1:1 ratio to either standard SLT or ClearSpeechTogether. Both treatment approaches lasted 6 weeks and involved comparable face to face input from therapists. The group randomised to standard SLT received 1 hour of individual therapy a week over 6 weeks. The group randomised to ClearSpeechTogether received four individual therapy sessions over two weeks, followed by daily group interaction for the following four weeks, including SLT contact once a week. All assessment and intervention sessions took place online via videoconferencing software.
Four speech assessments were conducted over the course of the project, two baseline assessments in the week preceding treatment, one immediate post-therapy assessment and one 8 week follow-up. Variation between the two baseline assessments was taken into account to determine the minimum difference necessary for post-treatment results to signal clinically relevant change.

Results: We will report findings on three main aspects:
Feasibility: rate of recruitment and attrition, data quality, access to telehealth;
Acceptability: adherence, fidelity, fatigue, and qualitative feedback of participants and clinicians;
Efficacy: signal of efficacy will be determined via speech assessments evaluating physiological functioning (breath support and voice quality), and impairment (intelligibility), and participatory levels (communication confidence, impact and participation). In addition, we collected qualitative interview data to capture patient reported benefits or problems.

Discussion: Research on rare conditions is particularly challenging in terms of recruitment, and little is known to what degree different manifestations of the same type of disorder might impact on intervention. The current project will provide such information by comparing results with our previous pilots for ClearSpeechTogether involving other, slower progressing ataxia variants. Demonstrating acceptability, feasibility and potential communication benefits in this pilot will set the basis for a larger registered randomised controlled trial, and area of significant need for rare conditions and motor speech disorders in general.