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  • Status : Approved
    • First Submitted Date : 2018/07/25
    • Registered Date : 2019/01/11
    • Last Updated Date : 2018/11/23
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1. Background

Background Information
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 
Address 222, Wangsimni-ro, Seongdong-gu, Seoul 
Telephone 02-2290-9653 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
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 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 Site Hanyang University Seoul Hospital 
Recruitment Status Completed  
Date of First Enrollment 2016-01-04 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Hanyang University Seoul Hospital 
Organization Type Medical Institute  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
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 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
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) * Diseases of the nervous system
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 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 Registerd Yes
Results Upload
Final Enrollment Number 66
Number of Publication
Results Upload 연구결과 파일저장 Results Donwload  
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 No 
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