Comparing the effectiveness of two types of speech therapy for MSA
Research type
Research Study
Full title
ClearSpeechTogether versus standard NHS speech intervention: A single, mixed method, rater blinded pilot randomised controlled trial for people living with MSA-C
IRAS ID
322064
Contact name
Anja Lowit
Contact email
Sponsor organisation
Strathclyde University
ISRCTN Number
ISRCTN44652664
Duration of Study in the UK
1 years, 2 months, 0 days
Research summary
This study will investigate the feasibility, acceptability and potential benefits of a novel, cost-effective and patient-centred model to treat speech problems in people with MSA-C.
Our novel therapy model (ClearSpeechTogether) combines individual sessions with a speech and language therapist (SLT) with group support sessions that are run by the patients themselves, under the guidance of the SLT. Our recent feasibility study showed that the intervention helped participants with progressive ataxia improve their speech, motivated them to practise more and to use their speech strategies in everyday communication, and that the groups provided psychological and social support which increased their confidence. Some participants also commented that ClearSpeechTogether was more effective in improving these aspects than the individual therapy they had previously received. Finally, ClearSpeechTogether is much more cost-effective as it only uses a small number of therapist sessions whilst providing patients with the opportunity to work on their speech intensively which helps to improve their communication.
This study aims to establish whether ClearSpeechTogether could also have communication benefits for people with MSA-C, and how acceptable the programme would be. Furthermore, we need to find out how feasible it is to inform the design of a future large scale randomised controlled trial.
We plan to recruit 24 people who will be randomly allocated to receive ClearSpeechTogether or standard NHS therapy. Each will receive 6 weeks of therapy, including four individual SLT sessions over two weeks, followed by daily patient led group meetings using SLT designed activities for another four weeks, with weekly check-in by the SLT. Those receiving standard SLT will meet individually with the therapist once a week. All sessions will take place online. We will evaluate feasibility, acceptability and potential communication benefit of ClearSpeechTogether versus standard therapy.Summary Results
Speech difficulties are an early symptom of MSA and can have significant impact on people’s quality of life. Although a few studies have recently shown that speech can improve after therapy, they used intensive therapy models that are not always possible to deliver under the NHS. Our study compared two alternative types of therapy. The first modelled the therapy often provided by the NHS, i.e. one individual session a week over 6 weeks. The second type, ClearSpeechTogether, consisted of a novel approach which combines individual with group therapy. Patients received 4 individual sessions over 2 weeks followed by 4 weeks of daily, patient led group practice resulting in 24 sessions in total, thus simulating intense therapy delivery without added workload on the speech and language therapist (SLT). Our study aimed to establish whether either of the two therapy types could have communication benefits for people with MSA-C (signal of efficacy), how acceptable the therapies would be to individuals (acceptability) and how feasible it would be to compare the two therapy types with each other in a larger trial to test their effectiveness (feasibility).
Each participant’s speech and communication participation and confidence was assessed before and after therapy, and they were interviewed about their views about the therapy outcomes. Furthermore, the SLT delivering the therapy was interviewed about her views on the CST versus standard NHS programme and how well CST could be integrated into usual NHS practice.
The results were as follows:
(1) Feasibility: We succeeded in recruiting the required number of participants (12 for each group). Dropouts stayed within acceptable limits. In the end we had 9 people completing all stages of the NHS arm, and 11 the CST arm. A number of participants required additional support with using the technology for the online meetings but everybody managed to join the sessions successfully.
(2) Acceptability: We had 100% attendance at the NHS sessions, and 80% for the CST programme, which fell within expectations. Nobody reported any negative impact on their energy levels from the therapy. Participants reported that the therapy fully addressed their needs The SLT reported no issues in providing the therapy.
(3) Signal for efficacy: Both types of therapy resulted in improvements for at least some of our participants in terms of the quality of their voice, how much breath they had available for speaking, and how well they were understood by others. The biggest improvements were observed for people’s confidence and also how much their MSA affected them in various speaking situations. We saw improvements in these aspects even if their speech did not change noticeably. There was a small indication, that CST might be more successful in achieving positive communication outcomes than the standard provision, but participant numbers were too small to show this reliably. About 30% of participants showed no change post-therapy, but at the same time reported that their overall condition had declined between assessments. Many in this group felt that if they had not received therapy, their communication would have declined in line with the rest of their status. This suggests that maintenance of abilities might also be an important outcome to consider in studies with people with MSA and that overall health status is an important aspect to monitor in any future trials.
Overall, this pilot RCT achieved its aims. We succeeded in delivering an RCT involving a group of patients that are significantly impacted by their condition with severe disability and rapid progression of their ataxia. Given the excellent feasibility achieved we believe that a larger trial involving a wider group of people with ataxia, the majority of which will be less severely affected that the group studied would be very feasible, Results on the acceptability of both therapy types are also promising, both from a patient and health care provider point of view. Finally, both therapies resulted in positive communication change in some of the participants, indicating that either of them has the potential to be an effective therapy approach for people with MSA.
The outcomes of this study provide a rationale and justification for a larger trial involving patients with ataxia of diverse aetiology to investigate the effectiveness of ClearSpeechTogether and potential superiority over other approaches.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
23/NW/0037
Date of REC Opinion
13 Mar 2023
REC opinion
Further Information Favourable Opinion