Plain English Summary
Background and study aims
Dysarthria, or slurred speech, is caused by muscle weakness and is common after a stroke. It happens when areas of the brain or nervous system that control the muscles used for speech are damaged. Dysarthria can lead to people feeling isolated, unconfident and uncomfortable in social situations. Speech therapy can offer support to people with dysarthria and help to reduce its symptoms, but this treatment is not always provided within the NHS. The aim of this study is to test a new technology called ReaDySpeech, a specially designed computer programme which aims to provide patients with greater access to personalised speech rehabilitation. ReaDySpeech technology will be trialled in this study with both clinicians and patients to see what they think of it. If clinicians and patients find the technology acceptable, a larger study will be designed from its results so that it can be tested with more people.
Who can participate?
Adults with dysarthria following a stroke.
What does the study involve?
All participants are given access to the ReaDySpeech computer programme. Users are asked to provide feedback on ReaDySpeech.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
University of Manchester (UK)
When is the study starting and how long is it expected to run for?
September 2015 to November 2016
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Mrs C Mitchell
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18964
Study information
Scientific title
ReaDySpeech for people with dysarthria after stroke: a feasibility study
Acronym
Study hypothesis
This study will test the feasibility of a new speech rehabilitation technology, ReaDySpeech, developed for patients with dysarthria. This study will assess its acceptability with clinicians and patients, and the results will be used in the design of a larger study.
Ethics approval
Ref: 15/NW/0371.
Study design
Randomised interventional treatment study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Stroke rehabilitation for dysarthria
Intervention
Participants will be given access to ReaDySpeech, a computer based programme designed to deliver speech therapy exercises to patients.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Activity measure.
Secondary outcome measures
Not available at time of registration.
Overall trial start date
01/09/2015
Overall trial end date
01/11/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participants will be selected by the clinician, within the inclusion criteria of more than 1 week post stroke
2. No upper limit to time post stroke
3. Participants will present with dysarthria, willing and able to undertake communication therapy (in clinicians' opinion)
4. Sufficient ability in English to participate in therapy without a translator
5. Medically stable
6. Able to give informed consent to participate
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 36
Participant exclusion criteria
1. Dysarthria for reason other than stroke
2. Not fluent in the English language (this may make using ReaDySpeech difficult)
3. Coexisting communication, cognitive, hearing or visual problems, significant enough to make using ReaDySpeech difficult
4. Coexisting progressive neurological condition
Recruitment start date
01/09/2015
Recruitment end date
01/11/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2017 protocol in: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-017-0169-0
2. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/29278019 (added 24/01/2019)