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

NCT ID: NCT03558308

Last Updated: 2021-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2021-07-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Acquired Brain Injury Cognitive Symptom Executive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Patients know that one of the conditions is a control-condition not expected to have significant clinical effects (required by the danish scientific committee), but they don't know which treatment condition they are randomised to. The outcome assessor is blind to the group allocation of patients.

Study Groups

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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.

Group Type EXPERIMENTAL

Computer based cognitive rehabilitation

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Computer based cognitive rehabilitation

Intervention Type BEHAVIORAL

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.

Brain+ without support

Intervention: computer based cognitive rehabilitation. This group will train with the programme 'Brain+' but receive no support during the intervention period.

Group Type EXPERIMENTAL

Computer based cognitive rehabilitation

Intervention Type BEHAVIORAL

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-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.

Group Type SHAM_COMPARATOR

Sham computerized gaming

Intervention Type OTHER

Sham training with generally stimulating computer-games

Interventions

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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.

Intervention Type BEHAVIORAL

Sham computerized gaming

Sham training with generally stimulating computer-games

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Katrine Sværke

OTHER

Sponsor Role lead

Responsible Party

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Katrine Sværke

Bsc. Psychology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jesper Mogensen, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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Center for Hjerneskade

Amager, København, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-18006890

Identifier Type: -

Identifier Source: org_study_id

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