- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405351
Telerehabilitation for Attention and Memory in Stroke (TEAMS)
Telerehabilitation for Attention and Memory in Stroke (TEAMS): Development and Initial Evaluation of an Internet-Based Training Program
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada
- Dalhousie University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Training Group
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).
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
Baseline
|
|
Change in working memory function between baseline and 6 weeks post training onset
Time Frame: 6 weeks post training onset
|
6 weeks post training onset
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Baseline cognitive function
Time Frame: Baseline
|
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)
|
Baseline
|
|
Baseline anxiety/depression
Time Frame: Baseline
|
Baseline anxiety/depression will be assessed using the Hospital Anxiety and Depression Scale (HADS; self-report screen for symptoms of anxiety and depression)
|
Baseline
|
|
Baseline premorbid intelligence quotient (IQ)
Time Frame: Baseline
|
Baseline IQ will be assessed using the Spot the Word test (participants are asked to identify the real word in a pair of words)
|
Baseline
|
|
Baseline aphasia assessment
Time Frame: Baseline
|
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)
|
Baseline
|
|
Change in aphasia assessment 6 weeks post training onset
Time Frame: 6 weeks post training onset
|
6 weeks post training onset
|
|
|
Baseline memory function
Time Frame: Baseline
|
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
|
Baseline
|
|
Change in in memory function 6 weeks post training onset
Time Frame: 6 weeks post training onset
|
6 weeks post training onset
|
|
|
Baseline executive functioning
Time Frame: Baseline
|
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)
|
Baseline
|
|
Change in executive functioning 6 weeks post training onset
Time Frame: 6 weeks post training onset
|
6 weeks post training onset
|
|
|
Baseline attention function
Time Frame: Baseline
|
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)
|
Baseline
|
|
Change in attention function 6 weeks post training onset
Time Frame: 6 weeks post training onset
|
6 weeks post training onset
|
|
|
Baseline behaviour and motivation
Time Frame: Baseline
|
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
|
Baseline
|
|
Change in behaviour and motivation 6 weeks post training onset
Time Frame: 6 weeks post training onset
|
6 weeks post training onset
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of feasibility and usability of approach
Time Frame: 6 weeks post training onset
|
We will be using a computerized System Usability Scale (SUS), asking about problems and opinions regarding our website
|
6 weeks post training onset
|
|
Assessment of functional activities
Time Frame: 6 weeks throughout study participation
|
Participants are asked to rate the level of achievement of each functional goal according to pre-defined criteria
|
6 weeks throughout study participation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Sarah Dolan, BSc, Dalhousie University
- Principal Investigator: Gail A Eskes, PhD, Dalhousie University
- Study Chair: Stephen Phillips, MD, Capital District Health Authority; Dalhousie University
- Study Chair: Anita Mountain, MD, Capital District Health Authority; Dalhousie University
- Study Chair: Diane MacKenzie, PhD, Capital District Health Authority; Dalhousie University
- Study Chair: Mary Gorman, MD, St. Martha's Regional Hospital; Dalhousie University
- Study Chair: Peggy Green, Nova Scotia Health Authority
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEAMS02102014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
Clinical Trials on Adaptive Working Memory Training
-
University of VermontCompleted
-
Gail EskesNova Scotia Health AuthorityActive, not recruiting
-
Kazimierz Wielki UniversityNational Science Centre, Poland; John Paul II Catholic University of Lublin...CompletedAging | Cognitive Decline | Old Age; DementiaPoland
-
University Hospital TuebingenGerman Federal Ministry of Education and ResearchCompletedSchizophrenia | Cognitive DeficitsGermany
-
Nottingham University Hospitals NHS TrustNational Institute for Health Research, United KingdomCompletedHearing LossUnited Kingdom
-
Wayne State UniversityRecruitingBehavior, HealthUnited States
-
University of GeorgiaRecruitingSchizophrenia | Schizo Affective DisorderUnited States
-
Milwaukee VA Medical CenterCompletedPosttraumatic Stress DisorderUnited States
-
KU LeuvenActive, not recruitingCerebral PalsyBelgium
-
Radboud University Medical CenterNetherlands Organisation for Scientific ResearchCompletedAttention Deficit Disorder With HyperactivityNetherlands