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Cognitive Rehabilitation With C8 Sciences

Primary Purpose

Stroke, Brain Injuries

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Computerized cognitive training program
Conventional cognitive rehabilitation
Sponsored by
National Rehabilitation Center, Seoul, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

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

Inclusion Criteria:

  • Participants with stroke or brain injury
  • Cognitive deficits

Exclusion Criteria:

  • Uncontrolled medical comorbidities
  • Not able to perform outcome measurements
  • Aphasia, which hamper communication
  • Pre-diagnosed psychological or other neurological disease not relevant to stroke or brain injury

Sites / Locations

  • National Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

C8 sciences

Conventional cognitive rehabilitation

Arm Description

cognitive rehabilitation with C8 sciences

cognitive rehabilitation with conventional methods

Outcomes

Primary Outcome Measures

Change from baseline Cambridge Neuropsychological Test Automated Battery(CANTAB) Spatial working memory at 34 th intervention
Change from baseline CANTAB Rapid Visual information Processing at 34 th intervention

Secondary Outcome Measures

CANTAB Spatial working memory
CANTAB Rapid Visual information Processing
CANTAB Motor control task
CANTAB Paired Associated Learning
CANTAB reaction time
CANTAB Attention Switching Task
CANTAB Stoking of Cambridge
CANTAB Emotion Recognition Task
CANTAB Stop Signal Task
Geriatric depression scale
Older participants
Beck depression index
Korean Mini-Mental State Examination (K-MMSE)
Korean activities of daily living (K-ADL)
Korean instrumental activities of daily living (K-IADL)
clinical dementia rating scale (CDR)
Stroke impact scale
Subjective memory complaint questionnaire
NIH toolbox
Autobiographical memory
Trail making test (A/B)
Trail making test - Black and White

Full Information

First Posted
February 23, 2015
Last Updated
March 5, 2018
Sponsor
National Rehabilitation Center, Seoul, Korea
Collaborators
Hanyang University, National IT Industry Promotion Agency, Republic of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02384057
Brief Title
Cognitive Rehabilitation With C8 Sciences
Official Title
Cognitive Rehabilitation for Participants With Stroke or Brain Injury Using C8 Sciences
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
October 27, 2017 (Actual)
Study Completion Date
October 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Rehabilitation Center, Seoul, Korea
Collaborators
Hanyang University, National IT Industry Promotion Agency, Republic of Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
C8 sciences program is a cognitive training program mainly developed for the students, and the effectiveness is well established. The aim of this trial is to assess clinical efficacy of the program for cognitive rehabilitation of the patients with stroke or brain injury.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
C8 sciences
Arm Type
Experimental
Arm Description
cognitive rehabilitation with C8 sciences
Arm Title
Conventional cognitive rehabilitation
Arm Type
Active Comparator
Arm Description
cognitive rehabilitation with conventional methods
Intervention Type
Other
Intervention Name(s)
Computerized cognitive training program
Intervention Description
1000 minutes of computerized cognitive rehabilitation with C8 sciences program
Intervention Type
Other
Intervention Name(s)
Conventional cognitive rehabilitation
Intervention Description
Same amount of conventional cognitive rehabilitation
Primary Outcome Measure Information:
Title
Change from baseline Cambridge Neuropsychological Test Automated Battery(CANTAB) Spatial working memory at 34 th intervention
Time Frame
Baseline, 34th day from baseline
Title
Change from baseline CANTAB Rapid Visual information Processing at 34 th intervention
Time Frame
Baseline, 34th day from baseline
Secondary Outcome Measure Information:
Title
CANTAB Spatial working memory
Time Frame
Baseline, 34th day from baseline, 64th day from baseline
Title
CANTAB Rapid Visual information Processing
Time Frame
Baseline, 34th day from baseline, 64th day from baseline
Title
CANTAB Motor control task
Time Frame
Baseline, 34th day from baseline, 64th day from baseline
Title
CANTAB Paired Associated Learning
Time Frame
Baseline, 34th day from baseline, 64th day from baseline
Title
CANTAB reaction time
Time Frame
Baseline, 34th day from baseline, 64th day from baseline
Title
CANTAB Attention Switching Task
Time Frame
Baseline, 34th day from baseline, 64th day from baseline
Title
CANTAB Stoking of Cambridge
Time Frame
Baseline, 34th day from baseline, 64th day from baseline
Title
CANTAB Emotion Recognition Task
Time Frame
Baseline, 34th day from baseline, 64th day from baseline
Title
CANTAB Stop Signal Task
Time Frame
Baseline, 34th day from baseline, 64th day from baseline
Title
Geriatric depression scale
Description
Older participants
Time Frame
Baseline, 34th day from baseline
Title
Beck depression index
Time Frame
Baseline, 34th day from baseline
Title
Korean Mini-Mental State Examination (K-MMSE)
Time Frame
Baseline, 34th day from baseline
Title
Korean activities of daily living (K-ADL)
Time Frame
Baseline, 34th day from baseline, 64th day from baseline
Title
Korean instrumental activities of daily living (K-IADL)
Time Frame
Baseline, 34th day from baseline, 64th day from baseline
Title
clinical dementia rating scale (CDR)
Time Frame
Baseline, 34th day from baseline
Title
Stroke impact scale
Time Frame
Baseline, 34th day from baseline
Title
Subjective memory complaint questionnaire
Time Frame
Baseline, 34th day from baseline, 64th day from baseline
Title
NIH toolbox
Time Frame
Baseline, 17th day from baseline, 34th day from baseline, 64th day from baseline
Title
Autobiographical memory
Time Frame
Baseline, 34th day from baseline
Title
Trail making test (A/B)
Time Frame
Baseline, 34th day from baseline, 64th day from baseline
Title
Trail making test - Black and White
Time Frame
Baseline, 34th day from baseline, 64th day from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with stroke or brain injury Cognitive deficits Exclusion Criteria: Uncontrolled medical comorbidities Not able to perform outcome measurements Aphasia, which hamper communication Pre-diagnosed psychological or other neurological disease not relevant to stroke or brain injury
Facility Information:
Facility Name
National Rehabilitation Center
City
Seoul
ZIP/Postal Code
142884
Country
Korea, Republic of

12. IPD Sharing Statement

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

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Cognitive Rehabilitation With C8 Sciences

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