CBCR for Executive Functions in Patients With ABI in the Chronic Phase

July 21, 2021 updated by: Katrine Sværke

The Effects of Computer Based Cognitive Rehabilitation on Executive Functions in Patients With Acquired Brain Injury in the Chronic Phase: A Pilot Study

This study examines the effects of computerbased cognitive rehabilitation on executive functions in the chronic phase after acquired brain injury

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study examines the effects of computerbased cognitive rehabilitation on executive functions in the chronic phase after acquired brain injury using two clinically developed programmes and one sham-intervention. Furthermore, the study consists of Groups that receives the computerized training both with and witouth support from a professional.

Study Type

Interventional

Enrollment (Actual)

72

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

  • Denmark
    • København
      • Amager, København, Denmark, 2300
        • Center for Hjerneskade

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Persons who are able to give an informed consent both verbally and in writing
  • Persons in the chronic phase after stroke or traumatic brain injury (more than one year post onset)
  • Persons who score less than the 30. Percentile in one or more of the primary outcome measures outlined above.

Exclusion Criteria:

  • Persons with neurodegenerative diseases
  • Persons with diseases which can influence executive functions such as ADHD
  • Persons who are motorically or cognitively unable to use a tablet and complete the CBCR-training

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brain+ with clinical support
Intervention: Computer based cognitive rehabilitation. This group will train with the programme 'Brain+' and receive continuous support from a clinician during the intervention period.
Behavioral: Computer based cognitive rehabilitation
Computer based cognitive rehabilitation is a supplementary computerized tool for cognitive rehabilitation design to train various cognitive functions. Many programmes are available. The current study investigates the effects on two such programmes on rehabilitation of executive functions in the chronic phase after acquired brain injury.
Experimental: Cogmed with continuous support
Intervention: computer based cognitive rehabilitation. This group will train with the programme 'Cogmed' and receive continuous support from a clinician during the intervention period.
Behavioral: Computer based cognitive rehabilitation
Computer based cognitive rehabilitation is a supplementary computerized tool for cognitive rehabilitation design to train various cognitive functions. Many programmes are available. The current study investigates the effects on two such programmes on rehabilitation of executive functions in the chronic phase after acquired brain injury.
Experimental: Brain+ without support
Intervention: computer based cognitive rehabilitation. This group will train with the programme 'Brain+' but receive no support during the intervention period.
Behavioral: Computer based cognitive rehabilitation
Computer based cognitive rehabilitation is a supplementary computerized tool for cognitive rehabilitation design to train various cognitive functions. Many programmes are available. The current study investigates the effects on two such programmes on rehabilitation of executive functions in the chronic phase after acquired brain injury.
Sham Comparator: Sham-training group
Intervention: Sham computerized gaming. This group will train computerized solitaire and other computerized games which are thought to be generally cognitive stimulating but with a very limit load on executive functions. This group will receive continuous support during the intervention period.
Other: Sham computerized gaming
Sham training with generally stimulating computer-games

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PASAT
Time Frame: 3 seconds
Paced auditory serial addition test, test of verbal working memory
3 seconds
Trail making test A+B
Time Frame: 5 minutes
Trail test A: Test of visual attention, trail test B: Test of visual working memory and cognitive shifts
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SDMT
Time Frame: 90 seconds
Symbol digit modalities test: Test of processing speed
90 seconds
Word fluency test
Time Frame: 1 min
Test of verbal fluency
1 min
Digit span (WAIS-IV)
Time Frame: 5 minutes
Test of verbal memory (forward) and working memory (backward)
5 minutes
Spatial span (WMS-III)
Time Frame: 5 minutes
Test of visuospatial memory (forward) and visuospatial working memory (backward)
5 minutes
Stroop colour and word test
Time Frame: 3 minutes
Test of inhibition
3 minutes
BNI-FS
Time Frame: 10 minutes
Barrow Neurological Institute Fatigue Scale: Test of fatigue after brain injury
10 minutes
Quality of Life after Brain Injury (QOLIBRI)
Time Frame: 10 minutes
Questionnaire about quality of life
10 minutes
Wordlist, Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time Frame: 10 minutes
Verbal memory test
10 minutes

Collaborators and Investigators

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

Sponsor

Katrine Sværke

Collaborators

University of Copenhagen

Investigators

  • Principal Investigator: Jesper Mogensen, Professor, University of Copenhagen

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 (Actual)

August 1, 2018

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

June 3, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (Actual)

June 15, 2018

Study Record Updates

Last Update Posted (Actual)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-18006890

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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