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The effect of Dobrain on cognition, language, and fine motor function in normal developing children and children with delayed development: single center, randomized, investigator-driven pilot study

Status Approved

  • First Submitted Date

    2018/09/03

  • Registered Date

    2018/10/05

  • Last Updated Date

    2018/09/16

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
    KCT0003247
    Unique Protocol ID 2018-0989
    Public/Brief Title The effect of Dobrain on cognition, language, and fine motor function in normal developing children and children with delayed development
    Scientific Title The effect of Dobrain on cognition, language, and fine motor function in normal developing children and children with delayed development: single center, randomized, investigator-driven pilot study
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    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 2018-0989
    Approval Date 2018-08-20
    Institutional Review Board Name Asan Medical Center Institutional Review Board
    Institutional Review Board Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul
    Institutional Review Board Telephone 02-3010-7166
    Data Monitoring Committee
  • 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 In Young Sung
    Title Professor
    Telephone +82-2-3010-3800
    Affiliation Asan Medical Center
    Address 88, Olympic-ro 43-gil,
    Contact Person for Public Queries
    Name Eun Jae Ko
    Title Professor
    Telephone +82-52-250-8660
    Affiliation Ulsan Univeristy Hospital
    Address 877, BANGEOJINSUNHWANDO-RO, DONG-GU, ULSAN, 44033, REP. OF KOREA
    Contact Person for Updating Information
    Name Eun Jae Ko
    Title Professor
    Telephone +82-52-250-8660
    Affiliation Ulsan Univeristy Hospital
    Address 877, BANGEOJINSUNHWANDO-RO, DONG-GU, ULSAN, 44033, REP. OF 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 Not yet recruiting
    Date of First Enrollment 2018-09-30 Anticipated
    Target Number of Participant 60
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Asan Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-09-30 ,
  • 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 Small and Medium Business Administration
    Organization Type Government
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Asan Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    There are a lot of children with developmental delay, and the number is increasing very fast. The number of them are estimated about 6,000,000 in the United States, 3,000,000 in the India, 600,000 in the Japan, and 300,000 in the South Korea. However, the number of the children who cannot receive cognitive treatments are very high: 93.7% for the United States, and 90% for the South Korea. Also, children who can receive cognitive rehabilitation routinely are very few. These imply the low accessibility of cognitive rehabilitation. There are many difficulties for the cognitive rehabilitation for these children: children have different developmental velocity, therefore standard curriculum does not exist; cognitive rehabilitation is needed one child to one therapist; the price of cognitive rehabilitation is very expensive; and data for the development of children are rare due to the difficulty of collecting.
    Now, Rehacom is the most widely used computer based cognitive rehabilitation program worldwide. Rehacom was developed in 1986 in Germany. It has many limitations: the price of the program is very expensive that only big hospitals with lots of patients only can own it; children who do not know letters and who cannot use computer feel difficult to use the program; the program is developed targeting children who use English; the program is not very interesting for the children; and the locations of input and output are different.
    Dobrain is a game developed to aid cognitive enhancement of children with cognitive age of 36-72 months. A team with more than 15 years of clinical experience developed more than 9,600 contents. There are many advantages of the program. It can be linked with any smart device at home and in rehabilitation centers. Therefore, the cognitive development programs can be applied to children up to 7 days a week. The contents of the program consist of animation with games, therefore it can be used easily in children. Touch screen system is used and one point touch, drag and drop, and rub techniques are need, which the children can adjust easily.
    Therefore, the aim of this study is to evaluate the effect of Dobrain in cognitive, language, and fine motor functions in normal developing children and in children with developmental delay.
  • 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
     Supportive Care
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Others (Dobrain)
    Intervention Description
    Children in the intervention group execute Dobrain for 40 minutes a session, 2 sessions a week, for 12 weeks (total 24 sessions). Whether the children use the program or not is remotely observed. During the period, normal developing children maintain private educations and children with developing delay maintain medicine and rehabilitation programs including physical therapy, occupational therapy, and speech therapy. 
    Children in the control group do not execute Dobrain for 12 weeks. During the period, normal developing children maintain private educations and children with developing delay maintain medicine and rehabilitation programs including physical therapy, occupational therapy, and speech therapy.
    Number of Arms 2
    Arm 1

    Arm Label

    Intervention group

    Target Number of Participant

    30

    Arm Type

    Experimental

    Arm Description

    Children in the intervention group execute Dobrain for 40 minutes a session, 2 sessions a week, for 12 weeks (total 24 sessions). Whether the children use the program or not is remotely observed. During the period, normal developing children maintain private educations and children with developing delay maintain medicine and rehabilitation programs including physical therapy, occupational therapy, and speech therapy.
    Arm 2

    Arm Label

    Control group

    Target Number of Participant

    30

    Arm Type

    Active comparator

    Arm Description

    Children in the control group do not execute Dobrain for 12 weeks. During the period, normal developing children maintain private educations and children with developing delay maintain medicine and rehabilitation programs including physical therapy, occupational therapy, and speech therapy.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F89)Unspecified disorder of psychological development 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    5Year~18Year

    Description

    (Normal developing children)
    Children were assessed for inclusion in the study according to the following criteria: (1) children with 5-6 years old, (2) children who maintain private educations, (3) children who are confirmed to develop normally by examinations and specialists, and (4) children whose caregivers provided a written informed consent. 
    
    (Children with developmental delay)
    Children were assessed for inclusion in the study according to the following criteria: (1) children with 5-18 years old, (2) children with cognitive age of 5-6 years, (3) children who maintain medicine and rehabilitation programs including physical therapy, occupational therapy, and speech therapy, and (4) children whose caregivers provided a written informed consent.
    Exclusion Criteria
    (Normal developing children)
    Exclusion criteria were as follows: (1) children with severe visual impairment, (2) children with poor medical condition who could not execute Dobrain, and (3) children who underwent Korean Wechsler Primary and Preschool Scale Intelligence, K-WPPSI (K-WPPSI) in 6 months.
    
    (Children with developmental delay)
    Exclusion criteria were as follows: (1) children with severe visual or motor impairment, (2) children with poor medical condition who could not execute Dobrain, and (3) children who underwent Korean Wechsler Primary and Preschool Scale Intelligence, K-WPPSI (K-WPPSI) in 6 months.
    Healthy Volunteers
  • 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
    Korean Wechsler Primary and Preschool Scale Intelligence-IV (K-WPPSI-IV)
    Timepoint
    Before and after intervention period
    Secondary Outcome(s) 1
    Outcome
    Pediatric Evaluation of Disability Inventory (PEDI)
    Timepoint
    Before and after intervention period
    Secondary Outcome(s) 2
    Outcome
    Goal Attainment Scale (GAS)
    Timepoint
    Before and after intervention period
    Secondary Outcome(s) 3
    Outcome
    Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2)
    Timepoint
    Before and after intervention period
    Secondary Outcome(s) 4
    Outcome
    PEP-R (Psycheducational Profile Revised)
    Timepoint
    Before and after intervention period
    Secondary Outcome(s) 5
    Outcome
    Korea-Child Behavior Checklist (K-CBCL)
    Timepoint
    Before and after intervention period
    Secondary Outcome(s) 6
    Outcome
    Analysis of quality of life of main caregiver
    Timepoint
    Before and after intervention period
    Secondary Outcome(s) 7
    Outcome
    Analysis of satisfaction and side effects
    Timepoint
    After intervention period
  • 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 No
  • 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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