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Telerehabilitation for Attention and Memory in Stroke (TEAMS)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Adaptive Working Memory Training
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Telemedicine, Stroke, Working Memory, Cognitive Training

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dalhousie University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Training Group

Arm Description

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).

Outcomes

Primary Outcome Measures

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
Change in working memory function between baseline and 6 weeks post training onset

Secondary Outcome Measures

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)
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)
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)
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)
Change in aphasia assessment 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
Change in in memory function 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)
Change in executive functioning 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)
Change in attention function 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
Change in behaviour and motivation 6 weeks post training onset

Full Information

First Posted
November 17, 2014
Last Updated
June 13, 2023
Sponsor
Nova Scotia Health Authority
Collaborators
Heart and Stroke Foundation of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02405351
Brief Title
Telerehabilitation for Attention and Memory in Stroke
Acronym
TEAMS
Official Title
Telerehabilitation for Attention and Memory in Stroke (TEAMS): Development and Initial Evaluation of an Internet-Based Training Program
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Scotia Health Authority
Collaborators
Heart and Stroke Foundation of Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Telemedicine, Stroke, Working Memory, Cognitive Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training Group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Adaptive Working Memory Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Baseline working memory function
Description
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
Time Frame
Baseline
Title
Change in working memory function between baseline and 6 weeks post training onset
Time Frame
6 weeks post training onset
Secondary Outcome Measure Information:
Title
Baseline cognitive function
Description
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)
Time Frame
Baseline
Title
Baseline anxiety/depression
Description
Baseline anxiety/depression will be assessed using the Hospital Anxiety and Depression Scale (HADS; self-report screen for symptoms of anxiety and depression)
Time Frame
Baseline
Title
Baseline premorbid intelligence quotient (IQ)
Description
Baseline IQ will be assessed using the Spot the Word test (participants are asked to identify the real word in a pair of words)
Time Frame
Baseline
Title
Baseline aphasia assessment
Description
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)
Time Frame
Baseline
Title
Change in aphasia assessment 6 weeks post training onset
Time Frame
6 weeks post training onset
Title
Baseline memory function
Description
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
Time Frame
Baseline
Title
Change in in memory function 6 weeks post training onset
Time Frame
6 weeks post training onset
Title
Baseline executive functioning
Description
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)
Time Frame
Baseline
Title
Change in executive functioning 6 weeks post training onset
Time Frame
6 weeks post training onset
Title
Baseline attention function
Description
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)
Time Frame
Baseline
Title
Change in attention function 6 weeks post training onset
Time Frame
6 weeks post training onset
Title
Baseline behaviour and motivation
Description
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
Time Frame
Baseline
Title
Change in behaviour and motivation 6 weeks post training onset
Time Frame
6 weeks post training onset
Other Pre-specified Outcome Measures:
Title
Assessment of feasibility and usability of approach
Description
We will be using a computerized System Usability Scale (SUS), asking about problems and opinions regarding our website
Time Frame
6 weeks post training onset
Title
Assessment of functional activities
Description
Participants are asked to rate the level of achievement of each functional goal according to pre-defined criteria
Time Frame
6 weeks throughout study participation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Dolan, BSc
Organizational Affiliation
Dalhousie University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gail A Eskes, PhD
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Phillips, MD
Organizational Affiliation
Capital District Health Authority; Dalhousie University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anita Mountain, MD
Organizational Affiliation
Capital District Health Authority; Dalhousie University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Diane MacKenzie, PhD
Organizational Affiliation
Capital District Health Authority; Dalhousie University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mary Gorman, MD
Organizational Affiliation
St. Martha's Regional Hospital; Dalhousie University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peggy Green
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Study Chair
Facility Information:
Facility Name
Dalhousie University
City
Halifax
State/Province
Nova Scotia
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Telerehabilitation for Attention and Memory in Stroke

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