Clinical trial NCT02405351: Telerehabilitation for Attention and Memory in Stroke
Official title: Telerehabilitation for Attention and Memory in Stroke (TEAMS): Development and Initial Evaluation of an Internet-Based Training Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Telemedicine, Stroke, Working Memory, Cognitive Training
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2015-04-01
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Baseline working memory function
timeFrame: Baseline
measure: Change in working memory function between baseline and 6 weeks post training onset
timeFrame: 6 weeks post training onset
Secondary outcomes:
measure: Baseline cognitive function
timeFrame: Baseline
measure: Baseline anxiety/depression
timeFrame: Baseline
measure: Baseline premorbid intelligence quotient (IQ)
timeFrame: Baseline
measure: Baseline aphasia assessment
timeFrame: Baseline
measure: Change in aphasia assessment 6 weeks post training onset
timeFrame: 6 weeks post training onset
measure: Baseline memory function
timeFrame: Baseline
measure: Change in in memory function 6 weeks post training onset
timeFrame: 6 weeks post training onset
measure: Baseline executive functioning
timeFrame: Baseline
measure: Change in executive functioning 6 weeks post training onset
timeFrame: 6 weeks post training onset
measure: Baseline attention function
timeFrame: Baseline
measure: Change in attention function 6 weeks post training onset
timeFrame: 6 weeks post training onset
measure: Baseline behaviour and motivation
timeFrame: Baseline
measure: Change in behaviour and motivation 6 weeks post training onset
timeFrame: 6 weeks post training onset
Other outcomes:
measure: Assessment of feasibility and usability of approach
timeFrame: 6 weeks post training onset
measure: Assessment of functional activities
timeFrame: 6 weeks throughout study participation
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Sarah Dolan, BSc
role: STUDY_DIRECTOR
affiliation: Dalhousie University
name: Gail A Eskes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Capital District Health Authority; Dalhousie University
name: Stephen Phillips, MD
role: STUDY_CHAIR
affiliation: Capital District Health Authority; Dalhousie University
name: Anita Mountain, MD
role: STUDY_CHAIR
affiliation: Capital District Health Authority; Dalhousie University
name: Diane MacKenzie, PhD
role: STUDY_CHAIR
affiliation: St. Martha's Regional Hospital; Dalhousie University
name: Mary Gorman, MD
role: STUDY_CHAIR
affiliation: Nova Scotia Health Authority
name: Peggy Green
role: STUDY_CHAIR
References: