ReaDySpeech: clinical testing
| ISRCTN | ISRCTN90031373 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90031373 |
| Secondary identifying numbers | 18337 |
- Submission date
- 04/02/2015
- Registration date
- 05/02/2015
- Last edited
- 24/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Dysarthria, or slurred speech, is caused by muscle weakness and is common after stroke. It leads to people feeling isolated, unconfident and uncomfortable in social situations. Speech therapy can offer support and reduce symptoms but is not always provided in the NHS. So we want to develop technologies, to enable more patients to access speech rehabilitation. This study will try the technology out with clinicians and patients to see what they think of it. If clinicians and patients think using technology is acceptable we will try it out with more people so we can fully test the technology.
Who can participate?
Clinicians that have agreed to be involved in both the preliminary testing phase of the study and the future feasibility study. Patients that have dysarthria as a result of stroke that had occurred at least 12 weeks ago.
What does the study involve?
This stage of the study involves clinicians testing out the computer based intervention with a small number of patients. The clinicians will continue their usual care but will also offer some patients the opportunity to try this new technology. Patients will be set up with a programme that they can access through any Wi-Fi enabled device such as a PC, laptop, mobile phone, tablet computer.
Patients will be asked to use it and to tell their clinician what they think of it. The clinician will be interviewed by the researcher following this clinical testing. The information from these questions along with the history of patient use will enable changes to be made to the next part of the study. It will help guide support and information needs for patients and therapists. It will also help the team to look at any improvements to ReaDySpeech.
What are the possible benefits and risks of participating?
There are no known benefits to take part as this intervention is still at an initial testing phase.
There are no known risks to participating. It could be anticipated that patients will feel pressure to use the intervention and find this stressful. Patients will be reassured that they should only use the intervention as much or as little as they wish.
Where is the study run from?
The study is run from the University of Manchester and using four NHS sites; Central Manchester University Hospital Foundation Trust, South Manchester University Hospital Trust, East Lancashire Hospital Trust, Salford Royal Hospital Trust.
When is the study starting and how long is it expected to run for?
February 2015 to July 2015
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Mrs Claire Mitchell
Contact information
Scientific
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
 ORCID ID |
0000-0002-2445-8468 |
|---|
Study information
| Study design | Non-randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | ReaDySpeech for people with dysarthria after stroke: initial clinical testing prior to feasibility study |
| Study objectives | This study is an initial clinical testing for the technology ReaDySpeech. ReaDySpeech has been developed to use with people with dysarthria following stroke and needs to be tested out in clinical practice before the next part of the study which is a feasibility randomised controlled trial. The ethics application for this initial clinical testing will involve asking a minimum of four speech and language therapists to test out the ReaDySpeech technology with two selected patients who have dysarthria following stroke. This initial test phase will help the researchers to find out what training and support is needed to use the ReaDySpeech technology, what clinicians and patients think of it and if any technical amendments need to be made to it. This initial part of the project will enable this information to be taken forward into the next part of the study, the feasibility study for which separate ethics approval will be sought. |
| Ethics approval(s) | NRES Committee South Central - Oxford B, 20/11/2014, ref: 14/SC/1320 |
| Health condition(s) or problem(s) studied | Topic: Stroke; Subtopic: Rehabilitation; Disease: Therapy type |
| Intervention | This is an initial clinical testing of ReaDySpeech, a computer based programme to deliver speech therapy exercises to patients. Patients will be set up with a programme in ReaDySpeech to test it out for a maximum of ten weeks or a minimum of one week. |
| Intervention type | Other |
| Primary outcome measure | Structured and open questions following testing phase of the intervention. The questions intend to find out training needs for patients and clinicians as well as support needs for patients and clinician. |
| Secondary outcome measures | Adherence to the online programme. Measured by online history of interaction. |
| Overall study start date | 01/02/2015 |
| Completion date | 31/07/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 12; UK Sample Size: 12 |
| Key inclusion criteria | Inclusion criteria for clinicians: Clinicians will be recruited from 4 North West NHS sites that have already agreed to be involved in both the preliminary testing phase of the study and the future feasibility study. These clinicians will have a stroke caseload. Inclusion criteria for patient participants: 1. Patients with dysarthria as a result of stroke as diagnosed by a speech and language therapist 2. Patients more than 12 weeks post stroke with no upper limit post stroke 3. Patients who are willing to trial the computer based programme ReaDySpeech. 4. Participants will present with dysarthria, willing and able to undertake communication therapy (in clinicians' opinion) 5. Sufficient ability in English to participate in therapy without a translator 6. Medically stable 7. Able to give informed consent to participate |
| Key exclusion criteria | There is no clinician exclusion criteria. Patient participant exclusion criteria: 1. Patients with cognitive or language difficulties that will prevent them giving informed consent or using a computer 2. Patients with insufficient grasp of English |
| Date of first enrolment | 01/03/2015 |
| Date of final enrolment | 31/07/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Manchester
M13 9PL
United Kingdom
Sponsor information
University/education
Oxford Road
Manchester
M13 9PL
England
United Kingdom
"ROR" |
https://ror.org/027m9bs27 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Dissemination will be comprehensive and include academics, clinicians and service users. To ensure patient groups are reached appropriately the best approaches will be decided with the PPI partners involved in this study. This may include presenting at local stroke groups, local network PCPI groups, information in an accessible report format for those wanting written information for example. To target relevant professional clinicians, presentations will be carried out at various speech and language therapy (National Royal College of Speech and Language Therapy conference) and stroke specific National (UK Stroke Forum). The findings from this initial testing phase will feed into the next stage of the research a clinical feasibility trial. It is intended that training needs, instruction information and any programme amendments will be provided as a result of this. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 31/12/2016 | 24/01/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
24/01/2019: Publication reference added
09/08/2017: No publications found in PubMed, verifying study status with principal investigator.
