NCT02405351

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

June 15, 2023

Status Verified

February 1, 2018

Enrollment Period

4.6 years

First QC Date

November 17, 2014

Last Update Submit

June 13, 2023

Conditions

Keywords

Telemedicine, Stroke, Working Memory, Cognitive Training

Outcome Measures

Primary Outcomes (2)

  • 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

    Baseline

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

    6 weeks post training onset

Secondary Outcomes (13)

  • Baseline cognitive function

    Baseline

  • Baseline anxiety/depression

    Baseline

  • Baseline premorbid intelligence quotient (IQ)

    Baseline

  • Baseline aphasia assessment

    Baseline

  • Change in aphasia assessment 6 weeks post training onset

    6 weeks post training onset

  • +8 more secondary outcomes

Other Outcomes (2)

  • Assessment of feasibility and usability of approach

    6 weeks post training onset

  • Assessment of functional activities

    6 weeks throughout study participation

Study Arms (1)

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).

Behavioral: Adaptive Working Memory Training

Interventions

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.

Training Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalhousie University

Halifax, Nova Scotia, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sarah Dolan, BSc

    Dalhousie University

    STUDY DIRECTOR
  • Gail A Eskes, PhD

    Dalhousie University

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2014

First Posted

April 1, 2015

Study Start

April 1, 2015

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

June 15, 2023

Record last verified: 2018-02

Locations