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Effect of Computer-Assisted Cognitive Rehabilitation in Unilateral Spatial Neglect Patients with Brain Damage

Status Approved

  • First Submitted Date

    2018/07/25

  • Registered Date

    2019/01/11

  • Last Updated Date

    2018/11/23

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003420
    Unique Protocol ID HYI-15-197-2
    Public/Brief Title Effect of Computer-Assisted Cognitive Rehabilitation in Unilateral Spatial Neglect Patients with Brain Damage
    Scientific Title Effect of Computer-Assisted Cognitive Rehabilitation in Unilateral Spatial Neglect Patients with Brain Damage
    Acronym Computer-Assisted Cognitive Rehabilitation(CACR), Conventional Rehabilitation(CR)
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number HYI-15-197-2
    Approval Date 2015-12-10
    Institutional Review Board Name Hanyang University Institutional Review Board
    Institutional Review Board Address 222, Wangsimni-ro, Seongdong-gu, Seoul
    Institutional Review Board Telephone 02-2290-9653
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Woncheol Kim
    Title O.T.
    Telephone +82-2-2290-9363
    Affiliation Hanyang University Seoul Hospital
    Address 222-1, Wangsimni-ro, Seongdong-gu, Seoul, Korea
    Contact Person for Public Queries
    Name Yeon-Gyu Jeong
    Title Physical therapist
    Telephone +82-31-512-2525
    Affiliation Dongguk University Ilsan Hospital
    Address 27, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea
    Contact Person for Updating Information
    Name Woncheol Kim
    Title O.T.
    Telephone +82-2-2290-9363
    Affiliation Hanyang University Seoul Hospital
    Address 222-1, Wangsimni-ro, Seongdong-gu, Seoul, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2016-01-04 Actual
    Target Number of Participant 68
    Primary Completion Date 2017-11-30 , Actual
    Study Completion Date 2016-11-30 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Hanyang University Seoul Hospital
    Recruitment Status Completed
    Date of First Enrollment 2016-01-04 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Hanyang University Seoul Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Hanyang University Seoul Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The purpose of this study is to compare the effectiveness of the computer-assisted cognitive rehabilitation (CACR) and conventional rehabilitation(CR) in patients with unilateral spatial neglect caused by brain damage. The participant of this study was for brain damage patients who underwent rehabilitation treatment at the H hospital in Seoul from January 2016 to November 2017. The experimental group applied the saccadic training, exploration, and visuo-motor coordination programs from the CACR, and the control group applied the hemispheric activation, mental imagery training and vibration therapy of the CR. Both groups carried out a total of 20 interventions, 30 minutes at a time, five times a week, four weeks. The experimental group and control groups conducted motor-free visual perception test (MVPT), line bisection test (LBT), visual span test-forward (VST), visual recognition test (VRT), mini-mental state examination Korean version (MMSE-K) and Korean version modified barthel index (K-MBI) tests before and after the intervention. Both the experimental group and the control group had functional improvements post interventions in MVPT, LBT, VST, VRT, MMSE-K, and K-MBI, but the experimental group was significantly improved in MVPT, VST, VRT, and MMSE-K(p<0.05). In particular, the experimental group was more valid than the control group for MVPT(d=1.06), VST(d=0.67), and VRT(d=1.12) (Cohen’s d≥0.5).
    The results of this study confirmed that the CACR was an effective intervention method for recovering patients with unilateral spatial neglect after brain damage.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type Others (Computer-Assisted Cognitive Rehabilitation, Conventional Rehabilitation)
    Intervention Description
    The experimental group received CACR intervention from RehaCom software 6.21 (HASOMED GmbH, Magdeburg, Germany)   to integrate visual spatial perception and visual memory. It consists of the visual saccadic eye movement (SAKA), visual memory and search (EXPL), and visuo-motor tracking of an object (WISO) programs as similar to an actual situation.
    
     SAKA is a program developed for visual  dysfunction and impairment in visual exploration. A visuo-perceptual stimulus object was programmed to appear from the left and right on the screen. In the training, the patient watched the location of a visuo-perceptual stimulus object on the horizon and pushed a button on the panel. The program is composed of the first step, the lowest level of difficulty, to the twenty eighth step, the highest level of difficulty. As the level of difficulty increases, the straight or slightly curved horizon changes into a complex shape, such as a nightscape. 
    
     EXPL is a visual search program developed for impairments in the field of vision. Patients can analyze the location of an object consistent and accurately to improve search skills. In this procedure, patient first memorized figures shown on the screen. Whenever various figures were shown on the screen, he/she found the given figures and pushed a button with the cursor passing. The program is composed of the first step, the lowest level of difficulty, to the thirtieth step, the highest level of difficulty. As the level of difficulty increases, the search area is expanded with the search speed increased and the size of target figures becoming smaller.
    
     WISO is a program developed for a visual motor coordination disorder. In the training, the patient moved a joystick as a cursor to match the movement of a visual stimulus object. The program is composed of the first step, the lowest level of difficulty, to the ninety sixth step, the highest level of difficulty. As the level of difficulty increases, the pattern of visual stimuli becomes more complex and difficult with the search speed increased and the size of target figures becoming smaller. 
    
     In the three programs, the first step of the intervention began at the first level. When the patient passed the test, they advanced to the next level. While he/she failed the test, the step was revised downward and the intervention lasted for a certain period of time. After termination, the result was automatically computerized and the latest step continued based on the previous records in the next intervention and facilitates training to integrate visual spatial perception and visual memory. 
    
     In the present study, the visual saccadic eye movement (SAKA), visual memory and search (EXPL), and visuo-motor tracking of an object (WISO) programs of the CACR were consisted of each ten minutes for a total of thirty minutes.
    
     The intervention for the control group was composed of Hemispheric Activation Approaches, Mental Imagery Training, and Vibration Therapy. The progam was consisted of each ten mintues for a total of thirty minutes as same duraton as CACR program
    Number of Arms 2
    Arm 1

    Arm Label

    CACR group

    Target Number of Participant

    34

    Arm Type

    Experimental

    Arm Description

    The experimental group applied a total of 20 CACR interventions 30 minutes a day, 5 times a week, and 4 weeks.
    
     SAKA is a program developed for visual  dysfunction and impairment in visual exploration. A visuo-perceptual stimulus object was programmed to appear from the left and right on the screen. In the training, the patient watched the location of a visuo-perceptual stimulus object on the horizon and pushed a button on the panel. The program is composed of the first step, the lowest level of difficulty, to the twenty eighth step, the highest level of difficulty. As the level of difficulty increases, the straight or slightly curved horizon changes into a complex shape, such as a nightscape. 
    
     EXPL is a visual search program developed for impairments in the field of vision. Patients can analyze the location of an object consistent and accurately to improve search skills. In this procedure, patient first memorized figures shown on the screen. Whenever various figures were shown on the screen, he/she found the given figures and pushed a button with the cursor passing. The program is composed of the first step, the lowest level of difficulty, to the thirtieth step, the highest level of difficulty. As the level of difficulty increases, the search area is expanded with the search speed increased and the size of target figures becoming smaller.
    
     WISO is a program developed for a visual motor coordination disorder. In the training, the patient moved a joystick as a cursor to match the movement of a visual stimulus object. The program is composed of the first step, the lowest level of difficulty, to the ninety sixth step, the highest level of difficulty. As the level of difficulty increases, the pattern of visual stimuli becomes more complex and difficult with the search speed increased and the size of target figures becoming smaller. 
    
     In the three programs, the first step of the intervention began at the first level. When the patient passed the test, they advanced to the next level. While he/she failed the test, the step was revised downward and the intervention lasted for a certain period of time. After termination, the result was automatically computerized and the latest step continued based on the previous records in the next intervention and facilitates training to integrate visual spatial perception and visual memory.
    Arm 2

    Arm Label

    CR group

    Target Number of Participant

    34

    Arm Type

    Active comparator

    Arm Description

    The intervention for the control group was composed of Hemispheric Activation Approaches, Mental Imagery Training,and Vibration Therapy. The progam was consisted of each ten mintues for a total of thirty minutes as same duraton as CACR program.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I64)Stroke, not specified as haemorrhage or infarction 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    No Limit~No Limit

    Description

    The inclusion criteria were as follows: patients who were diagnosed with brain damage or brain metabolic diseases by computerized tomography or magnetic resonance imaging; patients with suggested or indicated (moderate/severe) unilateral spatial neglect who under responding less than normal range of response behavior, classified by age and each response on the left or right side, as assessed by motor free visual perception test (MVPT);   sufficient cognition to participate in the training as assessed by a Mini-Mental State Examination (MMSE), score of 18 or higher.
    Exclusion Criteria
    Those who met the participation criteria but did not agree to participate in the study.
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Motor-Free Visual Perception Test (MVPT)
    Timepoint
    Before and after intervention.
    Primary Outcome(s) 2
    Outcome
    Line Bisection Test (LBT)
    Timepoint
    Before and after intervention.
    Secondary Outcome(s) 1
    Outcome
    Visual Span Test –forward (VST)
    Timepoint
    Before and after intervention.
    Secondary Outcome(s) 2
    Outcome
    Visual Recognition Test (VRT)
    Timepoint
    Before and after intervention.
    Secondary Outcome(s) 3
    Outcome
    Korean version Modified Barthel Index (K-MBI)
    Timepoint
    Before and after intervention.
    Secondary Outcome(s) 4
    Outcome
    Mini-Mental State Examination Korean version (MMSE-K)
    Timepoint
    Before and after intervention.
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered Yes
    Results Upload
    Final Enrollment Number 66
    Number of Publication 0
    Results Upload CACR연구결과.pdf
    Date of Posting Results 2019/01/11
    Protocol URL or File Upload
    Brief Summary
    In this study, scores on the VST and VRT significantly improved in the CACR group, compared to the CR group, in brain damaged patients with hemiplegic neglect. The effect size for the variables in the CACR group indicated at least moderate improvement compared to the CR group. Thus, CACR may be a more useful intervention to improve attention and memory in brain damaged patients with hemiplegic neglect. Henceforth, classification of specific diseases and long-term follow-up studies on CACR depending on the functional status of patients are required. 
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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