Online group and peer support speech therapy for people with progressive ataxia
| ISRCTN | ISRCTN93368860 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93368860 |
| Secondary identifying numbers | 12810 |
- Submission date
- 26/02/2021
- Registration date
- 02/03/2021
- Last edited
- 16/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Ataxia is a term for a group of disorders that affect co-ordination, balance and speech. People with progressive ataxia often suffer from communication difficulties. Currently, few of them are offered regular speech therapy to address these difficulties, and this has been made worse during the COVID-19 lockdown. The lockdown also meant that people with ataxia had less opportunities for social interaction, and that can make speaking worse than usual. In addition, staying isolated is not good for people’s mental health and wellbeing. The aim of this study is to investigate whether a small number of speech therapy sessions combined with group meetings of people with ataxia to practise speaking together can be as effective as seeing a speech therapist for many sessions individually.
Who can participate?
Patients aged over 16 with progressive ataxia who do not have any other neurological problems or communication problems that are not caused by their ataxia.
What does the study involve?
Participants will be tested twice 1 to 2 weeks before and twice after the intervention (immediately following therapy and 6 weeks later). The intervention itself consists of a 6-week programme and is delivered completely online. The researchers will offer four individual sessions with a speech and language therapist (SLT), to establish some good speaking behaviours that will serve as the basis for the exercises. After that, participants will meet online on Zoom for approx. 1 hour from Monday to Friday to work through speech exercises together. An SLT will join the group each week to check on progress and guide activities for the week. The SLT will also be available to meet with individuals if they run into any difficulties during the week. In addition, a volunteer will be available to support participants with technical issues during the group sessions. The therapy programme is based on a previous study that showed benefits for participants for their voice as well as their confidence in communicating. The participants will be split into two groups of five people each in order to keep the group size manageable and allow everyone to contribute during the session. The researchers will measure whether participants’ communication improved, what they thought about practising in groups and how tiring this was, whether they managed to join all the sessions, and whether we provided sufficient support from the SLT with this model.
What are the possible benefits and risks of participating?
It is hoped that participants’ communication will improve as part of this treatment. If it does not, the researchers might be able to suggest other methods that could have more success based on their individual presentation so that they can seek further treatment with their local NHS speech and language therapy department. Whatever the individual outcomes, it is hoped that the research will have wider benefits to people with ataxia and lead to improvements in care in the long term.
The treatment is relatively intensive and participants might experience some fatigue following sessions. The researchers have tried to take this into account by using the group format so they can get some rest during the session while the other participants are taking a turn. In addition, they will monitor their response to treatment closely and make adjustments during its course where necessary. There are no known negative side effects of the treatment or any of the assessment tasks.
Participants also need to consider that they will not be able to access any further speech treatment until the final evaluation 6 weeks after the end of their treatment. The researchers will indicate to them at the end of the therapy block whether they feel they would benefit from further input and they should make the necessary arrangements at that point.
Where is the study run from?
Strathclyde University (UK)
When is the study starting and how long is it expected to run for?
August 2020 to December 2021
Who is funding the study?
Ataxia UK
Who is the main contact?
Prof. Anja Lowit
a.lowit@strath.ac.uk
Contact information
Scientific
School of Psychological Sciences and Health
Strathclyde University
Glasgow
G1 1QE
United Kingdom
 ORCID ID |
0000-0003-0842-584X |
|---|---|
| Phone | +44 (0)7986080537 |
| a.lowit@strath.ac.uk |
Study information
| Study design | Single-centre interventional rater-blinded controlled pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A joint model of online speech and language therapist intervention and peer support to enhance communication effectiveness and participation in people with progressive ataxia |
| Study objectives | The aim of this pilot study is to investigate whether the regular practice of therapist guided speech exercises within a virtual peer group environment can improve communication effectiveness and participation in speakers with progressive ataxia. Primary question: 1. Can a joint model of speech and language therapist (SLT) intervention and peer group support result in improved communication effectiveness and participation as measured by speech outcomes and qualitative evaluation of participant views? Secondary Questions: 2. Does this mode of input enable regular participation and avoid negative impacts on the fatigue levels of participants? 3. Is the balance between SLT input and peer group practice appropriate? |
| Ethics approval(s) | Approved 17/12/2020, Strathclyde University Ethics Committee (16 Richmond St, Glasgow, G1 1XQ, UK; +44 (0)141 5524400; ethics@strath.ac.uk), ref: UEC20/92 |
| Health condition(s) or problem(s) studied | Progressive ataxia |
| Intervention | Each participant will be assessed four times, twice pre-treatment, and twice post-treatment. Pre-treatment assessments will take place 1-2 weeks apart. Post-treatment assessments will take place immediately after and 6 weeks following the end of the intervention. The treatment will follow the principles of LSVT, and be supplemented with a clear speech approach. The overall duration will be 6 weeks. During these, each participant will receive four individual sessions with an SLT (spread over 2 weeks). Subsequently, they will meet as a group (group size 5 participants) online via Zoom for approx. 1 hour Mondays to Fridays for a further 4 weeks to work through speech exercises. An SLT will join the group once a week to check on progress and guide activities for the week. The SLT will also be available to support individuals should they run into any difficulties during the week. A volunteer will be available to support participants with technical issues during the peer support sessions. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Speech data evaluated acoustically (sustained vowel length) as well as perceptually by naïve listeners (voice quality, intelligibility and naturalness) across all four assessment points 2. Patient perceptions of therapy outcomes and delivery format assessed using qualitatively analysed interview data from assessment 3 |
| Secondary outcome measures | 1. Fatigue measured using the Fatigue Rating Scale at assessments 1 and 3 2. Attendance patterns measured using attendance records during the 6-week intervention period 3. Need for additional sessions measured using attendance records during the 6-week intervention period |
| Overall study start date | 07/08/2020 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10 |
| Total final enrolment | 9 |
| Key inclusion criteria | 1. People with progressive ataxia and associated mild to moderate dysarthria 2. The lower age limit will be 16 years 3. Participants require adequate vision and hearing to participate in the prescribed activities |
| Key exclusion criteria | 1. Other medical conditions 2. Speech and language impairments beyond those associated with their ataxia |
| Date of first enrolment | 25/01/2021 |
| Date of final enrolment | 31/03/2021 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Glasgow
G1 1QE
United Kingdom
Sponsor information
University/education
16 Richmond St
Glasgow
G1 1XQ
Scotland
United Kingdom
| Phone | +44 (0)141 5524400 |
|---|---|
| ethics@strath.ac.uk | |
| Website | https://www.strath.ac.uk/ |
"ROR" |
https://ror.org/00n3w3b69 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Ataxia
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Available on request |
| Publication and dissemination plan | 1. Planned publication in high impact journal 2. Conference presentation at Motor Speech Conferences in 2022 3. Dissemination through Ataxia UK publications |
| IPD sharing plan | Current individual participant data (IPD) sharing statement as of 10/01/2022: The datasets generated during and/or analysed during the current study are/will be available upon request from Anja Lowit (a.lowit@strath.ac.uk). Relevant subsets will be published alongside the paper and deposited in the Strathclyde University data repository. Type of data: anonymised speech recordings, acoustic analysis results, anonymised patient details When the data will become available: March 2022 For how long: indefinitely By what access criteria data will be shared including with whom: for research purposes with other researchers For what types of analyses: further acoustic and linguistic analysis of data By what mechanism: researchers should contact the chief investigator to establish appropriate means of data transfer and ensure the relevant agreements are in place Whether consent from participants was obtained: yes Comments on data anonymization: data will be fully anonymised Any ethical or legal restrictions, any other comments: N/A Previous individual participant data (IPD) sharing statement: The datasets generated during and/or analysed during the current study are/will be available upon request from Anja Lowit (a.lowit@strath.ac.uk). Type of data: anonymised speech recordings, acoustic analysis results, anonymise patient details When the data will become available: January 2022 For how long: indefinitely By what access criteria data will be shared including with whom: for research purposes with other researchers For what types of analyses: further acoustic and linguistic analysis of data By what mechanism: researchers should contact the chief investigator to establish appropriate means of data transfer and ensure the relevant agreements are in place Whether consent from participants was obtained: yes Comments on data anonymization: data will be fully anonymised Any ethical or legal restrictions, any other comments: N/A |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/08/2022 | 16/12/2022 | Yes | No |
Editorial Notes
16/12/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
10/01/2022: The individual participant data (IPD) sharing statement has been updated and the IPD sharing summary "Stored in publicly available repository" has been added.
26/02/2021: Trial's existence confirmed by Strathclyde University Ethics Committee.
