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Effectiveness of Computer-based Cognitive Training for Executive Functions After Stroke

Primary Purpose

Stroke, Executive Dysfunction, Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CogniPlus
Training As Usual (TAU)
Sponsored by
TWGHs Wong Tai Sin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients are suffered from unilateral hemispheric stroke and with a confirmation by neuroimaging evidence from either computer tomography (CT) or magnetic resonance imaging (MRI);
  2. Patients are either at subacute stage or chronic stage, i.e. the patients are suffered from post-stroke after one month,
  3. Patients are age 60 years old or above;
  4. Patients are medically stable;
  5. Patients are Cantonese speaking,
  6. Patients can communicate and to follow at least three-step commands, and;
  7. Patients are willing to give written consent.

Exclusion Criteria:

  1. Patients are at acute stage, i.e the patients are suffered from stroke within 1 week;
  2. Patients with severe aphasia, swallowing disorders or other complications post-stroke that prevent them from successfully completing the assessments;
  3. Patients with any previously known psychiatric disorder or neurological disease excluding stroke;
  4. Patients are unable to given written consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental CBCT Group

    Training As Usual (TAU) Group

    Arm Description

    Participants of CBCT group will attend individual computer-based cognitive training sessions. Researcher will give instruction in the use of the computerized training programs and assists participants during their training sessions.

    Participants of TAU group will attend usual training sessions offered by the training centres with similar intensity and frequency as the CBCT training.

    Outcomes

    Primary Outcome Measures

    Change of Wisconsin Card Sorting Test Score
    The test consists of 128 card designs, participant is required to sort the cards under the categorization rules and feedback from examiner in about 20 minutes. The more categories achieved (range 0 to 6) and less perseverative errors (out of 128 trials) the better executive control. Moreover, the lower the total number of trials administered (total number of cards used) reflects greater efficiency of the participant in the task; in addition, the greater the total number of correct responses (number of successes in combinations according to the category) and the lower the total number of errors (number of incorrect combinations) also indicate the better the participant's performance.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 22, 2021
    Last Updated
    June 28, 2021
    Sponsor
    TWGHs Wong Tai Sin Hospital
    Collaborators
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04944004
    Brief Title
    Effectiveness of Computer-based Cognitive Training for Executive Functions After Stroke
    Official Title
    Effectiveness of Computer-based Cognitive Training for Executive Functions After Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2021 (Anticipated)
    Primary Completion Date
    July 1, 2022 (Anticipated)
    Study Completion Date
    October 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    TWGHs Wong Tai Sin Hospital
    Collaborators
    The Hong Kong Polytechnic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Objective: To determine the efficacy of computer-based cognitive training(CBCT) in patients with stroke in the community settings. Study Design: Single-blinded prospective, pre-test/post-test randomized controlled trial (RCT) will be conducted in 2 groups of participants that receiving training in community settings. Treatment groups will attend individualized CBCT programme using CogniPlus® while control group will continue attend conventional treatment as usual (TAU). Assessment on the means difference in assessing functions will be done after the study. Samples: 100 patients with stroke will be recruited from the community, using a sampling frame of selected diagnosis and homogeneity. Expected Findings: Find out the training effects of selected CBCT on EF and daily functioning in patients with stroke
    Detailed Description
    It is important to study the effectiveness of intervention post-stroke cognitive deficits in EF, Post-stroke patients with EF deficits will affect their abilities to successfully return to normal daily activity. Studies over the past decade have provided evidence of substantial gaps in our knowledge on how to effectively manage EF impairment post-stroke. To address these gaps there has been growing attention and research into the management of EF impairment post-stroke. Studies have been conducted to address some of these gaps specific to EF impairment and intervention research, and to investigate use of evidence-based practices for the management of EF impairment post-stroke. The literatures review of EF interventions identified different treatment approaches that were showing promise in helping persons with stroke to cope with EF deficits. The preliminary evidence on specific EF skill retraining suggested that structured, individualized, and intense computerized EF training could improve targeted EF impairments. Stroke patients with EF deficits often find it difficult in their daily activities, the impact of treatment might have potential to enhance rehabilitation and recovery. The translational framework described in (figure IV) describe ways to identify and investigate the evidence for the use of CBCT in specific EF interventions post-stroke. The study is thus required to find the impact of CBCT on a variety of outcomes, including not only measures of EF impairment, but also measures of daily activities and participation in everyday life situations that are affected in stroke patients having EF disorders.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Executive Dysfunction, Cognitive Impairment, Randomized Controlled Trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Single blinded
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental CBCT Group
    Arm Type
    Experimental
    Arm Description
    Participants of CBCT group will attend individual computer-based cognitive training sessions. Researcher will give instruction in the use of the computerized training programs and assists participants during their training sessions.
    Arm Title
    Training As Usual (TAU) Group
    Arm Type
    Active Comparator
    Arm Description
    Participants of TAU group will attend usual training sessions offered by the training centres with similar intensity and frequency as the CBCT training.
    Intervention Type
    Other
    Intervention Name(s)
    CogniPlus
    Intervention Description
    The CBCT programmes proposed in this study is called CogniPlus. This software package offers training of scientifically proven trainable cognitive functions. According to the user manual, the lifelike interactive system and its automatic adaptability to client's ability level made CogniPlus feasible in community settings.
    Intervention Type
    Other
    Intervention Name(s)
    Training As Usual (TAU)
    Intervention Description
    Training As Usual (TAU)
    Primary Outcome Measure Information:
    Title
    Change of Wisconsin Card Sorting Test Score
    Description
    The test consists of 128 card designs, participant is required to sort the cards under the categorization rules and feedback from examiner in about 20 minutes. The more categories achieved (range 0 to 6) and less perseverative errors (out of 128 trials) the better executive control. Moreover, the lower the total number of trials administered (total number of cards used) reflects greater efficiency of the participant in the task; in addition, the greater the total number of correct responses (number of successes in combinations according to the category) and the lower the total number of errors (number of incorrect combinations) also indicate the better the participant's performance.
    Time Frame
    Baseline, after completion of half of the programme (an average of 8 weeks), one month post-treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients are suffered from unilateral hemispheric stroke and with a confirmation by neuroimaging evidence from either computer tomography (CT) or magnetic resonance imaging (MRI); Patients are either at subacute stage or chronic stage, i.e. the patients are suffered from post-stroke after one month, Patients are age 60 years old or above; Patients are medically stable; Patients are Cantonese speaking, Patients can communicate and to follow at least three-step commands, and; Patients are willing to give written consent. Exclusion Criteria: Patients are at acute stage, i.e the patients are suffered from stroke within 1 week; Patients with severe aphasia, swallowing disorders or other complications post-stroke that prevent them from successfully completing the assessments; Patients with any previously known psychiatric disorder or neurological disease excluding stroke; Patients are unable to given written consent.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ray Li, MSc
    Phone
    852 98312636
    Email
    rayliot@yahoo.com.hk

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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