NCT02384057

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2017

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

2.9 years

First QC Date

February 23, 2015

Last Update Submit

March 5, 2018

Conditions

StrokeBrain Injuries

Outcome Measures

Primary Outcomes (2)

  • Change from baseline Cambridge Neuropsychological Test Automated Battery(CANTAB) Spatial working memory at 34 th intervention

    Baseline, 34th day from baseline

  • Change from baseline CANTAB Rapid Visual information Processing at 34 th intervention

    Baseline, 34th day from baseline

Secondary Outcomes (21)

  • CANTAB Spatial working memory

    Baseline, 34th day from baseline, 64th day from baseline

  • CANTAB Rapid Visual information Processing

    Baseline, 34th day from baseline, 64th day from baseline

  • CANTAB Motor control task

    Baseline, 34th day from baseline, 64th day from baseline

  • CANTAB Paired Associated Learning

    Baseline, 34th day from baseline, 64th day from baseline

  • CANTAB reaction time

    Baseline, 34th day from baseline, 64th day from baseline

  • +16 more secondary outcomes

Study Arms (2)

C8 sciences

EXPERIMENTAL

cognitive rehabilitation with C8 sciences

Other: Computerized cognitive training program

Conventional cognitive rehabilitation

ACTIVE COMPARATOR

cognitive rehabilitation with conventional methods

Other: Conventional cognitive rehabilitation

Interventions

Computerized cognitive training programOTHER

1000 minutes of computerized cognitive rehabilitation with C8 sciences program

C8 sciences
Conventional cognitive rehabilitationOTHER

Same amount of conventional cognitive rehabilitation

Conventional cognitive rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with stroke or brain injury
  • Cognitive deficits

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Rehabilitation Center

Seoul, 142884, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 35349186DERIVED

MeSH Terms

Conditions

StrokeBrain Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Team manager

Study Record Dates

First Submitted

February 23, 2015

First Posted

March 10, 2015

Study Start

December 1, 2014

Primary Completion

October 27, 2017

Study Completion

October 27, 2017

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

KR(1)