Treating post-stroke speech difficulties by computer therapy
| ISRCTN | ISRCTN88245643 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88245643 |
| Secondary identifying numbers | MAY07/16 |
- Submission date
- 13/05/2015
- Registration date
- 22/05/2015
- Last edited
- 25/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Stroke and other forms of brain injury can disrupt people's thinking and behaviour in a number of ways. A common complication experienced by people following a stroke is an impairment of speech and language, called apraxia of speech (AOS). AOS results in reduced speech intelligibility, fluency and speed, and as a result an individual’s ability to communicate thoughts and needs is impaired. AOS is viewed by many clinicians as a ‘difficult to treat’ disorder. This is because treatment to stimulate new and improved organisation in damaged parts of the brain requires intensive, well-structured stimulation tasks. However, it is often difficult to achieve the necessary levels of stimulation within the framework of standard treatment consultations. A major factor in this is the limited amount of time clinicians are able to spend with patients. Self-administered, home-based computer therapy creates the opportunity to improve rehabilitation outcomes by allowing patients to take some control over their treatment. It also helps to increase the amount of time a patient spends carrying out brain stimulation tasks. The aim of this study is to see whether a computer-based speech therapy programme for AOS improves speech clarity in post-stroke patients. It also aims to see if this type of treatment is acceptable to patients and their families. It will also assess the financial costs associated with this type of treatment.
Who can participate?
Adults diagnosed with speech production problems following a stroke.
What does the study involve?
All participants take part in both interventions, however the order in which they are carried out is randomised. Initially, participants are randomly allocated into one of two groups. Those in group 1 (intervention group) are given a computer software programme to use at home. The software is a speech intervention aimed at stimulation and production of whole words, and putting words into sentences. Those in group 2 (control group) are given a software programme that involves visual puzzles and is not predicted to improve speech production. Participants take part in one of the interventions for 6 weeks, and then they cross over to the other group to take part in the other intervention for a further 6 weeks. Participants are asked to complete questionnaires and take part in clinical assessments during the study period.
What are the possible benefits and risks of participating?
At the end of the study, some participants might be able to say some words more easily and clearly. The therapy is a behavioural intervention and is therefore unlikely to cause harm. However, a participant might become frustrated if unfamiliar with using a computer. There are no specific risks associated with participating in this study. It is very unlikely that speech would get worse, but it might not change at all, or there might be only very small improvements.
Where is the study run from?
University of Sheffield (UK)
When is the study starting and how long is it expected to run for?
April 2008 to March 2011
Who is funding the study?
The BUPA UK Foundation
Who is the main contact?
Prof R Varley
Contact information
Scientific
University College London
Psychology & Language Sciences
London
WC1N 1PF
United Kingdom
 ORCID ID |
0000-0002-1278-0601 |
|---|
Scientific
University of Sheffield
Human Communication Sciences
Sheffield
S10 2TS
United Kingdom
| ORCID ID |
0000-0002-6672-9369 |
|---|
Study information
| Study design | Single centre intervention trial with a cross-over design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| 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 | Self-administered behavioural intervention for communication impairments following stroke |
| Study objectives | 1. Are there changes in speech production for treated items only, or do any improvements generalise to untreated words? 2. Is the intervention acceptable to service users and is it cost effective? |
| Ethics approval(s) | NRES Committee Yorkshire & The Humber - Sheffield, 25/03/2008, ref: 08/H1308/14. |
| Health condition(s) or problem(s) studied | Post-stroke speech production impairments (apraxia of speech and aphasic word production impairment) |
| Intervention | All participants will take part in both interventions, the order will be randomised: 1. Intervention group use a participant-administered software therapy designed specifically for this study (Sheffield Word (Sword)) that treats whole word production for six weeks 2. Control group use a sham-participant-administered software program that involves completion of visual-spatial tasks for six weeks |
| Intervention type | Behavioural |
| Primary outcome measure | Accuracy of word production in naming and repetition measured by: 1. Naming accuracy 2. Repetition accuracy 3. Word duration 4. Connected speech (narrative) samples Control measures: 1. CAT Spoken sentence to picture matching 2. PALPA48 Written word to picture matching |
| Secondary outcome measures | 1. Health economic assessment (health-related quality of life, resource use & societal costs) measured by: 1.1. EQ-5D Health questionnaire 1.2. SF-12v2. Health Status questionnaire 1.3. Costs questionnaire 2. Acceptability to service users and families of self-administered computer therapy |
| Overall study start date | 01/04/2008 |
| Completion date | 31/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Patients experiencing unilateral left-hemisphere lesion(s) 2. Minimum 6 months post onset of stroke 3. Diagnosis of apraxia of speech |
| Key exclusion criteria | 1. Not pre-morbidly competent in English 2. Insufficient auditory and visual acuity to interact with a laptop computer 3. Currently receiving impairment-based speech/language therapy 4. Presence of degenerative neurocognitive impairment |
| Date of first enrolment | 15/04/2008 |
| Date of final enrolment | 01/10/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Sheffield
S10 2TN
United Kingdom
Sponsor information
University/education
Research Office
Western Bank
Sheffield
S10 2TN
England
United Kingdom
"ROR" |
https://ror.org/05krs5044 |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/12/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Full reporting planned for 2015. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2016 | Yes | No |
Editorial Notes
25/01/2016: Added publication reference.
