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

Acquired Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558308
• Other study ID #: H-18006890
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2021
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Cognitive Symptom
• Executive Dysfunction
• Neurobehavioral Manifestations

Intervention

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.

Other:
• Sham computerized gaming
Sham training with generally stimulating computer-games

Locations

Country	Name	City	State
Denmark	Center for Hjerneskade	Amager	København

Sponsors (2)

Lead Sponsor	Collaborator
Katrine Sværke	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASAT	Paced auditory serial addition test, test of verbal working memory	3 seconds
Primary	Trail making test A+B	Trail test A: Test of visual attention, trail test B: Test of visual working memory and cognitive shifts	5 minutes
Secondary	SDMT	Symbol digit modalities test: Test of processing speed	90 seconds
Secondary	Word fluency test	Test of verbal fluency	1 min
Secondary	Digit span (WAIS-IV)	Test of verbal memory (forward) and working memory (backward)	5 minutes
Secondary	Spatial span (WMS-III)	Test of visuospatial memory (forward) and visuospatial working memory (backward)	5 minutes
Secondary	Stroop colour and word test	Test of inhibition	3 minutes
Secondary	BNI-FS	Barrow Neurological Institute Fatigue Scale: Test of fatigue after brain injury	10 minutes
Secondary	Quality of Life after Brain Injury (QOLIBRI)	Questionnaire about quality of life	10 minutes
Secondary	Wordlist, Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	Verbal memory test	10 minutes