Condition category
Circulatory System
Date applied
20/05/2015
Date assigned
21/05/2015
Last edited
26/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Mrs Claire Mitchell

ORCID ID

Contact details

University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

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 below 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 measures

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

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

Sponsor information

Organisation

University of Manchester

Sponsor details

Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes