A comparison of two forms of speech therapy (SLT) for people with multiple system atrophy (MSA; a rare condition of the nervous system that causes gradual damage to nerve cells in the brain) type C (that is characterised by cerebellar ataxia [poor muscle control])

Approved 12/04/2023, North West - Greater Manchester West Research Ethics Committee (Barlow House 3rd Floor 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)207 104 8057, 2071048065; gmwest.rec@hra.nhs.uk), ref: 23/NW/0037

1. Feasibility: feasibility for a larger trial will be monitored with the following aspects:
1.1. Levels of interest in the study during the recruitment process (approaches to research team);
1.2. Conversion to consent (considering patient consent and fit with inclusion criteria, target = 75% of those identified agree to participate);
1.3. Rate of recruitment (number of consenting participants in 6 months, target = 24);
1.4. Rate of attrition (target = 75% retention rate);
1.5. Data quality (target = 75 % of participants’ own recordings and 90% of researcher back-up recordings of sufficient quality for analysis);
1.6. Access to telehealth (target = 75% of those consenting have access to necessary technology and support to use it).
2. Acceptability: acceptability will be evaluated both from a participant and clinician/health economic perspective:
Participants:
2.1. Adherence to the therapy programme (target = 80% attendance);
2.2. Fidelity to treatment programme (home practice diary - target = 75% completion of daily exercises (assuming some over-reporting); volunteer observations during peer group sessions);
2.3. Fatigue levels (target = less than 10% decline in overall fatigue level on the Fatigue Impact Scale attributed to participation);
2.4. Qualitative feedback regarding the appropriateness of the exercises, the balance between individual and group sessions (Arm 1), quality of support provided in sessions, and the scheduling intensity of the sessions. There is no standardised assessment that captures the wider psychosocial benefits of individual or group intervention. In line with Steginga et al., we will co-create a questionnaire with our advisory group based on our pilot study comments to gather structured feedback that will allow us to capture any added benefits arising from group intervention.

Therapists:
2.5. Fidelity to treatment programme: evaluation of 20% of session recordings;
2.6. Need for additional individual or group support (target = no more than 1 additional session required per participant); we will consult a health economist to identify further parameters that need to be considered in a full RCT;
2.7. Qualitative interview feedback regarding workload management;
2.8. An international survey for SLTs working with MSA-C concerning current practice and potential to integrate ClearSpeechTogether into patient care models.

Communication: Potential communication benefits will be assessed at each assessment point across all ICF levels, including the physiological (breath support and voice quality), the functional (intelligibility) and participatory levels (communication confidence, impact and participation). We are also including a maximum performance task (syllable repetition (DDK)). Whilst performance in this task is not expected to change with treatment, it can monitor overall physiological decline due to disease progression. Speech will be evaluated both acoustically and perceptually. Within group statistical analyses will be performed to compare In addition, we will collect qualitative interview data to capture patient-reported benefits or problems. Therapist notes will also be reviewed for potential adverse effects (such as vocal strain) arising from the treatments.

Measured at pre- and post-therapy:
1. Communication participation: CPIB scores
2. Intelligibility: perceptual evaluation by 5 blinded trained listeners of read and free speech, acoustic segmental feature analysis
3. Breath support: maximum phonation time (MPT)
4. Voice quality: perceptual assessment by 5 blinded trained listeners for connected speech and prolonged vowels using the Cape-V
5. Syllable repetition: acoustic analysis of rate and variability