Cognitive Rehabilitation With C8 Sciences

March 5, 2018 updated by: Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

Cognitive Rehabilitation for Participants With Stroke or Brain Injury Using C8 Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: C8 sciences
cognitive rehabilitation with C8 sciences
Other: Computerized cognitive training program
1000 minutes of computerized cognitive rehabilitation with C8 sciences program
Active Comparator: Conventional cognitive rehabilitation
cognitive rehabilitation with conventional methods
Other: Conventional cognitive rehabilitation
Same amount of conventional cognitive rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline Cambridge Neuropsychological Test Automated Battery(CANTAB) Spatial working memory at 34 th intervention
Time Frame: Baseline, 34th day from baseline
Baseline, 34th day from baseline
Change from baseline CANTAB Rapid Visual information Processing at 34 th intervention
Time Frame: Baseline, 34th day from baseline
Baseline, 34th day from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CANTAB Spatial working memory
Time Frame: Baseline, 34th day from baseline, 64th day from baseline
Baseline, 34th day from baseline, 64th day from baseline
CANTAB Rapid Visual information Processing
Time Frame: Baseline, 34th day from baseline, 64th day from baseline
Baseline, 34th day from baseline, 64th day from baseline
CANTAB Motor control task
Time Frame: Baseline, 34th day from baseline, 64th day from baseline
Baseline, 34th day from baseline, 64th day from baseline
CANTAB Paired Associated Learning
Time Frame: Baseline, 34th day from baseline, 64th day from baseline
Baseline, 34th day from baseline, 64th day from baseline
CANTAB reaction time
Time Frame: Baseline, 34th day from baseline, 64th day from baseline
Baseline, 34th day from baseline, 64th day from baseline
CANTAB Attention Switching Task
Time Frame: Baseline, 34th day from baseline, 64th day from baseline
Baseline, 34th day from baseline, 64th day from baseline
CANTAB Stoking of Cambridge
Time Frame: Baseline, 34th day from baseline, 64th day from baseline
Baseline, 34th day from baseline, 64th day from baseline
CANTAB Emotion Recognition Task
Time Frame: Baseline, 34th day from baseline, 64th day from baseline
Baseline, 34th day from baseline, 64th day from baseline
CANTAB Stop Signal Task
Time Frame: Baseline, 34th day from baseline, 64th day from baseline
Baseline, 34th day from baseline, 64th day from baseline
Geriatric depression scale
Time Frame: Baseline, 34th day from baseline
Older participants
Baseline, 34th day from baseline
Beck depression index
Time Frame: Baseline, 34th day from baseline
Baseline, 34th day from baseline
Korean Mini-Mental State Examination (K-MMSE)
Time Frame: Baseline, 34th day from baseline
Baseline, 34th day from baseline
Korean activities of daily living (K-ADL)
Time Frame: Baseline, 34th day from baseline, 64th day from baseline
Baseline, 34th day from baseline, 64th day from baseline
Korean instrumental activities of daily living (K-IADL)
Time Frame: Baseline, 34th day from baseline, 64th day from baseline
Baseline, 34th day from baseline, 64th day from baseline
clinical dementia rating scale (CDR)
Time Frame: Baseline, 34th day from baseline
Baseline, 34th day from baseline
Stroke impact scale
Time Frame: Baseline, 34th day from baseline
Baseline, 34th day from baseline
Subjective memory complaint questionnaire
Time Frame: Baseline, 34th day from baseline, 64th day from baseline
Baseline, 34th day from baseline, 64th day from baseline
NIH toolbox
Time Frame: Baseline, 17th day from baseline, 34th day from baseline, 64th day from baseline
Baseline, 17th day from baseline, 34th day from baseline, 64th day from baseline
Autobiographical memory
Time Frame: Baseline, 34th day from baseline
Baseline, 34th day from baseline
Trail making test (A/B)
Time Frame: Baseline, 34th day from baseline, 64th day from baseline
Baseline, 34th day from baseline, 64th day from baseline
Trail making test - Black and White
Time Frame: Baseline, 34th day from baseline, 64th day from baseline
Baseline, 34th day from baseline, 64th day from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Rehabilitation Center, Seoul, Korea

Collaborators

Hanyang University
National IT Industry Promotion Agency, Republic of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

October 27, 2017

Study Completion (Actual)

October 27, 2017

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Actual)

March 6, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRC-2013-04-036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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