ISRCTN ISRCTN59754564
DOI https://doi.org/10.1186/ISRCTN59754564
Protocol serial number 17621
Sponsor Medical Research Council (MRC) (UK)
Funder Stroke Association
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Polly Peers
Scientific

MRC Cognition and Brain Sciences Unit
15 Chaucer Road
Cambridge
CB2 7EF
United Kingdom

Email polly.peers@mrc-cbu.cam.ac.uk

Study information

Primary study designInterventional
Study designRandomised; Interventional; Design type: Treatment
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleProgressive home-based working memory and attention training following stroke, implications for spatial bias: a preliminary study
Study objectivesIn 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) studiedTopic: Stroke; Subtopic: Rehabilitation; Disease: Therapy type
InterventionIn 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 typeOther
Primary outcome measure(s)

Spatial Bias measure derived from Theory of Visual Attention paradigm

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/09/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration100
Total final enrolment80
Key inclusion criteria1. 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 criteria1. Medical problems likely to prevent participation
2. Language problems likely to prevent comprehension of consent or the training instructions.
Date of first enrolment01/11/2014
Date of final enrolment01/09/2017

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

MRC Cognition and Brain Sciences Unit
Cambridge
CB2 7EF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing planOpen 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?
HRA research summary 28/06/2023 No No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Preprint results non-peer-reviewed results in preprint 01/07/2013 08/04/2021 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.