StrokeTEAMSNCT02405351
Telerehabilitation for Attention and Memory in Stroke
A study testing Adaptive Working Memory Training in people with Stroke, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The investigators propose to develop a Telerehabilitation approach to working memory training for patients experiencing working memory deficits post stroke. The investigators have currently developed a game-like computerized working memory training program that can be accessed via the internet for research purposes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Adaptive Working Memory Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- at least 3 months post first stroke documented clinically or by imaging
- subjective concerns or objective assessment data regarding deficits in attention and working memory ability
- normal or corrected-to-normal vision
- have access to a computer at home
Who cannot join
- severe aphasia or dementia
- other neurological diagnosis such as epilepsy, multiple sclerosis, Parkinson's disease
- current diagnosis of a severe psychiatric disorder such as major depressive disorder or psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telerehabilitation for Attention and Memory in Stroke (TEAMS): Development and Initial Evaluation of an Internet-Based Training Program
The investigators propose to develop a Telerehabilitation approach to working memory training for patients experiencing working memory deficits post stroke. The investigators have currently developed a game-like computerized working memory training program that can be accessed via the internet for research purposes. The investigators propose to refine the website to focus more on clinically based training, and to evaluate the feasibility and initial effectiveness of this approach in a pilot study with participants after stroke.
Read the detailed description
Vascular disease and stroke often affect working memory, which is the ability to hold information in mind in order to deal with tasks, such as reading, having a conversation, problem-solving and decision-making. Working memory deficits can lead to problems with everyday activities, affecting independence and quality of life. Thus, interventions to improve working memory are important for optimal health outcomes in individuals after stroke.
Currently, approaches to provide interventions for working memory deficits are limited to intensive face-to-face rehabilitation sessions requiring trained therapists over many weeks. Even one-on-one computerized training requires significant health care resources, however, including supervision of daily sessions by a trained therapist, set-up of the program on the computer, teaching the patient how to use the program, regular encouragement and feedback to maintain motivation, monitoring of progress, and trouble-shooting when there are difficulties. Thus, access to these interventions is usually restricted to patients currently in hospital in urban areas, and limited or not available to those in the community once discharged, or when treated in hospital in more rural settings. Thus, new approaches to increase accessibility of this intervention approach to patients are needed.
The investigators developed one method of working memory training which uses a computerized, game-like approach, which is ideal for providing intensive, repetitive practice, with feedback and monitoring of progress. While the maximally effective dose is not yet identified, adaptive training practice normally is provided for 5 days/week for 5-10 weeks. With this intensity, computerized working memory training has been shown to improve cognitive abilities in a range of groups (e.g., healthy younger and older adults, those with Attention deficit hyperactivity disorder (ADHD), stroke, schizophrenia) and these benefits can generalize to other cognitive abilities and be maintained, at least in the short term.
The investigators propose to develop and evaluate an internet-based intervention approach, using the computerized working memory method that has been shown to be effective in improving working memory in several patient groups, including stroke. The investigators will develop and refine a website that the investigators can use to provide an already available computerized game-like software program for working memory training, and conduct an initial evaluation of this approach for feasibility and effectiveness in a pilot study involving clinical sites in Nova Scotia.
- Conditions
- Stroke
- Being tested
- Adaptive Working Memory Training
- Keywords
- Telemedicine, Stroke, Working Memory, Cognitive Training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Working Memory TrainingBehavioural
The working memory training task will consist of an online adaptive working memory program that will test and extend patients' working memory capacity.
Adaptive refers to the increase in the number of items that the patient is required to remember.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Participants will be 10 individuals post stroke, living in the community. The intervention, adaptive working memory training, is a dual n-back working memory task. This training will take place once for 30 minutes per day, 5 days a week for 6 weeks, with one week dedicated for familiarizing participants to the program in the very beginning (i.e., Week 1). Receives: Behavioral: Adaptive Working Memory Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline working memory function
Using operation and symmetry span task, as well as as Sternberg memory scanning tasks Operation span task: A dual-task in which participants complete mathematical reasoning (e.g. solving a mathematical equation) while using short-term verbal memory to remember words.
Symmetry span task: A dual task in which participants discriminate about the symmetry of visual stimuli while using short-term spatial memory to remember the locations of stimuli.
Sternberg memory scanning tasks: A task that involved remembering various number of cards as memory test
Measured: Baseline
Change in working memory function between baseline and 6 weeks post training onset
Measured: 6 weeks post training onset
Secondary outcomes (13)
Baseline cognitive function
Baseline cognitive function will be assessed using the Montreal Cognitive Assessment Test (MoCA; Cognitive screening tool with short tests of attention and executive function, language, memory, perception, and abstraction)
Measured: Baseline
Baseline anxiety/depression
Baseline anxiety/depression will be assessed using the Hospital Anxiety and Depression Scale (HADS; self-report screen for symptoms of anxiety and depression)
Measured: Baseline
Baseline premorbid intelligence quotient (IQ)
Baseline IQ will be assessed using the Spot the Word test (participants are asked to identify the real word in a pair of words)
Measured: Baseline
Baseline aphasia assessment
Baseline aphasia assessment will be done using the Discourse Comprehension Test (test assesses comprehension and retention of stated and implied main ideas from ten stories with questions that require yes/no-responses)
Measured: Baseline
Change in aphasia assessment 6 weeks post training onset
Measured: 6 weeks post training onset
Baseline memory function
Baseline memory function will be assessed using the Hopkins Verbal Learning Test-Revised (HVLT-R; Learning of a list of words over 5 trials is measured both immediately and after a delay) as well as the Logical Memory unit I and II (participants are told two stories and then asked to repeat the stories verbatim and after delay) from the Wechsler Memory Scale -Revised
Measured: Baseline
Change in in memory function 6 weeks post training onset
Measured: 6 weeks post training onset
Baseline executive functioning
Baseline executive functioning will be assessed using the Trail Making Test A and B (assessment of psychomotor speed, mental flexibility), semantic and phonemic fluency tests (participants are asked to recall words for one minute starting with a specific letter or in a specific category), and the Stroop task (participants are shown words written in different colours and asked to indicate the colour of the word, while trying to ignore the word itself)
Measured: Baseline
Change in executive functioning 6 weeks post training onset
Measured: 6 weeks post training onset
Baseline attention function
Baseline attention function will be assessed using the Dalhousie Computerized Attention Battery (DalCAB; a series of computer tasks used to measure processing speed, sustained attention, visual search, dual task, and inhibition of automatic responses), the Digit Span unit (participants are asked to repeat a number series that increases in length) from the Wechsler Adult Intelligence Scale (WAIS-III), the d2 Test of Attention (participants are asked to identify and cross out a specified symbol while ignoring distracters, and the Brief Test of Attention (a voice reads 10 lists of letters and numbers of increasing length and participants have to ignore letters and count the numbers and vice versa)
Measured: Baseline
Change in attention function 6 weeks post training onset
Measured: 6 weeks post training onset
Baseline behaviour and motivation
Baseline behaviour and motivation will be assessed using the Dysexecutive Questionnaire (DEX; self-report questionnaire of daily memory and executive functioning mistakes), and the Cognitive Failures Questionnaire (CFQ; self-report questionnaire regarding minor mistakes/failures in daily situations involving perception, memory, and motor control within the last six months), as well as a motivational questionnaire asking about motivation and intentions regarding cognitive training
Measured: Baseline
Change in behaviour and motivation 6 weeks post training onset
Measured: 6 weeks post training onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- Sarah Dolan, BSc, Study director, Dalhousie UniversityGail A Eskes, PhD, Principal investigator, Dalhousie UniversityStephen Phillips, MD, Study chair, Capital District Health Authority; Dalhousie UniversityAnita Mountain, MD, Study chair, Capital District Health Authority; Dalhousie UniversityDiane MacKenzie, PhD, Study chair, Capital District Health Authority; Dalhousie UniversityMary Gorman, MD, Study chair, St. Martha's Regional Hospital; Dalhousie UniversityPeggy Green, Study chair, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405351
- Sponsor's protocol ID
- TEAMS02102014
- Acronym
- TEAMS
- Status last verified
- Feb 2018
- First submitted
- 17 Nov 2014
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation for Attention and Memory in Stroke (TEAMS): Development and Initial Evaluation of an Internet-Based Training Program
- ClinicalTrials.gov ID
- NCT02405351
- Acronym / sponsor ID
- TEAMS / TEAMS02102014
- Conditions
- Stroke
- Keywords
- Telemedicine, Stroke, Working Memory, Cognitive Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Apr 2015
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to develop a Telerehabilitation approach to working memory training for patients experiencing working memory deficits post stroke. The investigators have currently developed a game-like computerized working memory training program that can be accessed via the internet for research purposes. The investigators propose to refine the website to focus more on clinically based training, and to evaluate the feasibility and initial effectiveness of this approach in a pilot study with participants after stroke.
Detailed description
Vascular disease and stroke often affect working memory, which is the ability to hold information in mind in order to deal with tasks, such as reading, having a conversation, problem-solving and decision-making. Working memory deficits can lead to problems with everyday activities, affecting independence and quality of life. Thus, interventions to improve working memory are important for optimal health outcomes in individuals after stroke.
Currently, approaches to provide interventions for working memory deficits are limited to intensive face-to-face rehabilitation sessions requiring trained therapists over many weeks. Even one-on-one computerized training requires significant health care resources, however, including supervision of daily sessions by a trained therapist, set-up of the program on the computer, teaching the patient how to use the program, regular encouragement and feedback to maintain motivation, monitoring of progress, and trouble-shooting when there are difficulties. Thus, access to these interventions is usually restricted to patients currently in hospital in urban areas, and limited or not available to those in the community once discharged, or when treated in hospital in more rural settings. Thus, new approaches to increase accessibility of this intervention approach to patients are needed.
The investigators developed one method of working memory training which uses a computerized, game-like approach, which is ideal for providing intensive, repetitive practice, with feedback and monitoring of progress. While the maximally effective dose is not yet identified, adaptive training practice normally is provided for 5 days/week for 5-10 weeks. With this intensity, computerized working memory training has been shown to improve cognitive abilities in a range of groups (e.g., healthy younger and older adults, those with Attention deficit hyperactivity disorder (ADHD), stroke, schizophrenia) and these benefits can generalize to other cognitive abilities and be maintained, at least in the short term.
The investigators propose to develop and evaluate an internet-based intervention approach, using the computerized working memory method that has been shown to be effective in improving working memory in several patient groups, including stroke. The investigators will develop and refine a website that the investigators can use to provide an already available computerized game-like software program for working memory training, and conduct an initial evaluation of this approach for feasibility and effectiveness in a pilot study involving clinical sites in Nova Scotia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Behavioral: Adaptive Working Memory TrainingParticipants will be 10 individuals post stroke, living in the community. The intervention, adaptive working memory training, is a dual n-back working memory task. This training will take place once for 30 minutes per day, 5 days a week for 6 weeks, with one week dedicated for familiarizing participants to the program in the very beginning (i.e., Week 1). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- at least 3 months post first stroke documented clinically or by imaging
- subjective concerns or objective assessment data regarding deficits in attention and working memory ability
- normal or corrected-to-normal vision
- have access to a computer at home
Key exclusion criteria (3 listed)
- severe aphasia or dementia
- other neurological diagnosis such as epilepsy, multiple sclerosis, Parkinson's disease
- current diagnosis of a severe psychiatric disorder such as major depressive disorder or psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Working Memory TrainingThe working memory training task will consist of an online adaptive working memory program that will test and extend patients' working memory capacity. Adaptive refers to the increase in the number of items that the patient is required to remember. | Behavioural | Training Group |
Primary outcome
Baseline working memory function
Time frame: Baseline
Using operation and symmetry span task, as well as as Sternberg memory scanning tasks Operation span task: A dual-task in which participants complete mathematical reasoning (e.g. solving a mathematical equation) while using short-term verbal memory to remember words. Symmetry span task: A dual task in which participants discriminate about the symmetry of visual stimuli while using short-term spatial memory to remember the locations of stimuli. Sternberg memory scanning tasks: A task that involved remembering various number of cards as memory test
Change in working memory function between baseline and 6 weeks post training onset
Time frame: 6 weeks post training onset
13 secondary outcomes
Baseline cognitive function
Time frame: Baseline
Baseline anxiety/depression
Time frame: Baseline
Baseline premorbid intelligence quotient (IQ)
Time frame: Baseline
Baseline aphasia assessment
Time frame: Baseline
Change in aphasia assessment 6 weeks post training onset
Time frame: 6 weeks post training onset
Baseline memory function
Time frame: Baseline
Change in in memory function 6 weeks post training onset
Time frame: 6 weeks post training onset
Baseline executive functioning
Time frame: Baseline
Change in executive functioning 6 weeks post training onset
Time frame: 6 weeks post training onset
Baseline attention function
Time frame: Baseline
Change in attention function 6 weeks post training onset
Time frame: 6 weeks post training onset
Baseline behaviour and motivation
Time frame: Baseline
Change in behaviour and motivation 6 weeks post training onset
Time frame: 6 weeks post training onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Dolan, BSc study director
Dalhousie University
Gail A Eskes, PhD principal investigator
Dalhousie University
Stephen Phillips, MD study chair
Capital District Health Authority; Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Working Memory Training in people with Stroke, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline working memory function (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.