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
CRIS Registration Number |
KCT0003247 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Small and Medium Business Administration |
Organization Type | Government |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Asan Medical Center |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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 |
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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
Condition(s)/Problem(s) |
* (F00-F99)Mental and behavioural disorders (F89)Unspecified disorder of psychological development |
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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)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Korean Wechsler Primary and Preschool Scale Intelligence-IV (K-WPPSI-IV) |
|
Timepoint | Before and after intervention period |
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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 |
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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 |
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Secondary Outcome(s) 7 | ||
Outcome | Analysis of satisfaction and side effects |
|
Timepoint | After intervention period |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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