Investigating the effects of cognitive training on attention
| ISRCTN | ISRCTN59754564 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59754564 |
| Secondary identifying numbers | 17621 |
- Submission date
- 23/10/2014
- Registration date
- 23/10/2014
- Last edited
- 13/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Cognitive problems, including in attention and working memory, are common consequences of a stroke. Studies have suggested that progressive computerized training (i.e. training exercises that become more challenging as performance improves) can enhance cognitive function not simply on the exercises that people have practiced, but more generally.
Who can participate?
People aged over 18 who have had a stroke
What does the study involve?
Participants are randomly allocated to one of three groups: home-based online working memory training, a similar training programme focused on attention skills, or a waiting list control group. All participants are first assessed on a range of cognitive tasks and questionnaires about everyday function. These assessments are repeated after the 4 weeks of training and again at a 3-month follow-up. Participants in the training groups are asked to try to complete 20 minutes per working day over the 4 weeks. Participants in the waiting list control group are allocated to one of the active training programmes after the follow-up. In addition to the relative effectiveness of the training programmes, this study examines the feasibility of recruiting participants, the acceptability of the interventions to participants, and other factors that will inform a larger study if the results are positive.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
MRC Cognition and Brain Sciences Unit (UK)
When is the study starting and how long is it expected to run for?
November 2014 to September 2017
Who is funding the study?
Stroke Association (UK)
Who is the main contact?
Dr Polly Peers
polly.peers@mrc-cbu.cam.ac.uk
Contact information
Scientific
MRC Cognition and Brain Sciences Unit
15 Chaucer Road
Cambridge
CB2 7EF
United Kingdom
| polly.peers@mrc-cbu.cam.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Progressive home-based working memory and attention training following stroke, implications for spatial bias: a preliminary study |
| Study objectives | In addition to the relative efficacy of the training programmes compared with the waiting list condition, the study will examine the feasibility of recruitment, the acceptability of the interventions to participants and other factors that will inform a definitive trial if the results are positive. More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=17621 |
| Ethics approval(s) | 14/EE/0149 |
| Health condition(s) or problem(s) studied | Topic: Stroke; Subtopic: Rehabilitation; Disease: Therapy type |
| Intervention | In this study we aim to recruit people who have had a stroke and randomly allocate them to one of three conditions: home-based online working memory training, a similar training programme focused on attention skills; or a waiting list control group. All participants will be first assessed on a range of cognitive tasks and questionnaires about everyday function. These assessments will be repeated after the 4 weeks of training/waiting list and again at a 3 month follow-up. Participants in the training groups will be asked to try to complete 20 minutes per working day (MonFri) over the 4 weeks. Participants in the waiting list study will be allocated to one of the active training conditions after the followup. |
| Intervention type | Other |
| Primary outcome measure | Spatial Bias measure derived from Theory of Visual Attention paradigm |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/2014 |
| Completion date | 01/09/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100; UK Sample Size: 100 |
| Total final enrolment | 80 |
| Key inclusion criteria | 1. Over 18 years old 2. Able to give informed consent 3. Ability to interact with the computer with either hand or via the mouse |
| Key exclusion criteria | 1. Medical problems likely to prevent participation 2. Language problems likely to prevent comprehension of consent or the training instructions. |
| Date of first enrolment | 01/11/2014 |
| Date of final enrolment | 01/09/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
CB2 7EF
United Kingdom
Sponsor information
Research council
MRC Cognition and Brain Sciences Unit
15 Chaucer Road
Cambridge
CB2 7EF
United Kingdom
"ROR" |
https://ror.org/03x94j517 |
|---|
Funders
Funder type
Charity
Private sector organisation / Associations and societies (private and public)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Open access data will be available through the University of Cambridge sympletic repository. They will become publically available on publication of the paper at the link: https://doi.org/10.17863/CAM.66310. The data is currently under embargo and will become available once the paper is accepted for publication. The data is fully anonymised and the anonymised data along with copies of the analyses will be available in the repository. At the time of consent patients gave consent for anonymised data to be made freely available to other researchers. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Preprint results | non-peer-reviewed results in preprint | 01/07/2013 | 08/04/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/04/2021: Total final enrolment and IPD sharing statement added.
08/04/2021: Publication reference added.
16/02/2016: Plain English summary added.
