search
Back to results

Effects of Computer Assisted Cognitive Rehabilitation on Patients With Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Computer Assited Cognitive rehabilitation
Conventional Cognitive Rehabilitation
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke

Eligibility Criteria

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

Inclusion Criteria:

  • Patients over 18 years of age with stroke

Exclusion Criteria:

  • Problems with sight
  • Comorbid neurological disease
  • Cognitive impairment prior to stroke
  • Neglect Syndrome
  • Wernicke or Global aphasia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Computer Assisted Cognitive Rehabilitation

    Conventional Cognitive Rehabilitation

    Waiting list controls

    Arm Description

    Patients will receive their therapies 1 day a day, 2-3 days a week. The computer-aided cognitive rehabilitation group will perform simulation-based exercises, including exercises related to attention, in a special computer program (Cogniplus TR version) during therapy hours, and patients will progress to the difficulty level automatically. Their performance during this process (response time etc.) will be recorded.

    The home (paper pen) exercise group will take the necessary exercises on paper suitable for their respective levels and the daily tasks suitable for their functional needs and interests.

    These patients will get no intervention as means of cognitive rehabilitation, but will get their usual treatments.

    Outcomes

    Primary Outcome Measures

    Stroop test
    Stroop test is a quick measurement for ability of color perception and focusing attention Participants are asked to read 112 words with color within 2 min. Then, they are required to tell the color of these 112 words as color-word association. Finally, time of accomplishing task and number of correct read, corrections and errors are examined.
    Trail making
    Trail making test is used to evaluate the attention and velocity. Participants are asked to sequentially connect 25 circles with number which was written in only one style (Line A), or to sequentially connect 25 circles with number which was written in two styles (Line B). The time used to complete the line A or B and the number of errors and fouls are recorded and analyzed.

    Secondary Outcome Measures

    Beck Depression Index
    It is a test frequently used to assess depressive symptoms in chronic diseases. It is comprised of 21 items, 8 of which investigate the somatic symptoms of depression (such as loss of appetite and difficulty sleeping) and 13 of which address the cognitive-affective symptoms of depression (e.g., despair, social withdrawal). The BDI is scored as follows: 0-9: no symptoms; 10-16: mild depression; 17-29: moderate depression; and 30-63: severe depression
    Quality of Life Assessment
    Medical Outcomes Study 36-item Short Form Survey (SF-36). This is one of the most widely used scales evaluating quality of life. The SF-36 explores eight dimensions of the quality of life "physical function", "physical role", "bodily pain", "general health", "vitality", "social function", "emotional role" and "mental health". All scales were linearly transformed to a 0 to 100 scoring, with 100 indicating most favorable health state and 0 indicating the least favorable health state
    Functional Independence
    The FIM is a generic and global activity scale that measures an individual's independence in conducting his or her daily fundamental physical and cognitive activities. The FIM measures 81 items in two areas: 1) physical/motor function (13 items) and 2) cognitive/ psychosocial function (5 items). The items are divided into six subgroups according to activities, four physical and two cognitive. Each item is scored on a scale of one to seven, with "level 1" indicating that the patient needs complete help and "level 7" indicating complete independence. The total FIM score varies between 18 and 126.

    Full Information

    First Posted
    March 22, 2019
    Last Updated
    March 25, 2019
    Sponsor
    Ege University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03890159
    Brief Title
    Effects of Computer Assisted Cognitive Rehabilitation on Patients With Stroke
    Official Title
    Effects of Computer Assisted Cognitive Rehabilitation on Patients With Stroke in Attention, Functional Independence and Quality of Life
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2019 (Anticipated)
    Primary Completion Date
    April 1, 2020 (Anticipated)
    Study Completion Date
    April 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ege University

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study aims to investigate the effects of computer assisted cognitive rehabilitation and conventional cognitive rehabilitation methods on patients' attention, quality of life and functional independence. Recruiting from 15 patients from each group, patients will be followed up for a month and the outcome measures will be repeated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Computer Assisted Cognitive Rehabilitation
    Arm Type
    Experimental
    Arm Description
    Patients will receive their therapies 1 day a day, 2-3 days a week. The computer-aided cognitive rehabilitation group will perform simulation-based exercises, including exercises related to attention, in a special computer program (Cogniplus TR version) during therapy hours, and patients will progress to the difficulty level automatically. Their performance during this process (response time etc.) will be recorded.
    Arm Title
    Conventional Cognitive Rehabilitation
    Arm Type
    Experimental
    Arm Description
    The home (paper pen) exercise group will take the necessary exercises on paper suitable for their respective levels and the daily tasks suitable for their functional needs and interests.
    Arm Title
    Waiting list controls
    Arm Type
    No Intervention
    Arm Description
    These patients will get no intervention as means of cognitive rehabilitation, but will get their usual treatments.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Computer Assited Cognitive rehabilitation
    Intervention Description
    Patients will receive their therapies 1 day a day, 2-3 days a week. The computer-aided cognitive rehabilitation group will perform simulation-based exercises, including exercises related to attention, in a special computer program (Cogniplus TR version) during therapy hours. The total duration of intervention will be 1 month.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Conventional Cognitive Rehabilitation
    Intervention Description
    Patients will receive their therapies 1 day a day, 2-3 days a week. The home (paper pen) exercise group will take the necessary exercises on paper suitable for their respective levels and the daily tasks suitable for their functional needs and interests. The total duration of intervention will be 1 month.
    Primary Outcome Measure Information:
    Title
    Stroop test
    Description
    Stroop test is a quick measurement for ability of color perception and focusing attention Participants are asked to read 112 words with color within 2 min. Then, they are required to tell the color of these 112 words as color-word association. Finally, time of accomplishing task and number of correct read, corrections and errors are examined.
    Time Frame
    1 month
    Title
    Trail making
    Description
    Trail making test is used to evaluate the attention and velocity. Participants are asked to sequentially connect 25 circles with number which was written in only one style (Line A), or to sequentially connect 25 circles with number which was written in two styles (Line B). The time used to complete the line A or B and the number of errors and fouls are recorded and analyzed.
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Beck Depression Index
    Description
    It is a test frequently used to assess depressive symptoms in chronic diseases. It is comprised of 21 items, 8 of which investigate the somatic symptoms of depression (such as loss of appetite and difficulty sleeping) and 13 of which address the cognitive-affective symptoms of depression (e.g., despair, social withdrawal). The BDI is scored as follows: 0-9: no symptoms; 10-16: mild depression; 17-29: moderate depression; and 30-63: severe depression
    Time Frame
    Baseline, Month 1
    Title
    Quality of Life Assessment
    Description
    Medical Outcomes Study 36-item Short Form Survey (SF-36). This is one of the most widely used scales evaluating quality of life. The SF-36 explores eight dimensions of the quality of life "physical function", "physical role", "bodily pain", "general health", "vitality", "social function", "emotional role" and "mental health". All scales were linearly transformed to a 0 to 100 scoring, with 100 indicating most favorable health state and 0 indicating the least favorable health state
    Time Frame
    1 month
    Title
    Functional Independence
    Description
    The FIM is a generic and global activity scale that measures an individual's independence in conducting his or her daily fundamental physical and cognitive activities. The FIM measures 81 items in two areas: 1) physical/motor function (13 items) and 2) cognitive/ psychosocial function (5 items). The items are divided into six subgroups according to activities, four physical and two cognitive. Each item is scored on a scale of one to seven, with "level 1" indicating that the patient needs complete help and "level 7" indicating complete independence. The total FIM score varies between 18 and 126.
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients over 18 years of age with stroke Exclusion Criteria: Problems with sight Comorbid neurological disease Cognitive impairment prior to stroke Neglect Syndrome Wernicke or Global aphasia
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hale Karapolat, M.D.
    Phone
    +902323903682
    Email
    halekarapolat@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    35349186
    Citation
    Gibson E, Koh CL, Eames S, Bennett S, Scott AM, Hoffmann TC. Occupational therapy for cognitive impairment in stroke patients. Cochrane Database Syst Rev. 2022 Mar 29;3(3):CD006430. doi: 10.1002/14651858.CD006430.pub3.
    Results Reference
    derived

    Learn more about this trial

    Effects of Computer Assisted Cognitive Rehabilitation on Patients With Stroke

    We'll reach out to this number within 24 hrs