Early Training of Attention After Acquired Brain Injury

NCT02091453 | Completed

• 1 other identifier: APT 1&2
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Background: To study intensive targeted cognitive rehabilitation of attention in the acute (\<4 months) and subacute rehabilitation phases (4 -12 months) after acquired brain injury and to evaluate the effects on function, activity and participation (return to work). Design: prospective, randomised, controlled study. Methods: 120 consecutive patients with stroke or traumatic brain injury are randomised to 20 hours of intensive attention training by Attention Process Training or by standard, activity based training. Progress is evaluated by Statistical Process Control and by pre and post measurement of functional and activity levels. Return to work is also evaluated in the post-acute phase. Primary endpoints are the changes in the attention measure, Paced Auditory Serial Addition Test and changes in work ability. Secondary endpoints include measurement of cognitive functions, activity and work return. There are 3, 6 and 12-month follow ups focussing on health economics. Discussion: The study will provide information on rehabilitation of attention in the early phases after acquired brain injury (ABI); effects on function, activity and return to work. Further, the application of Statistical Process Control might enable closer investigation of the cognitive changes after acquired brain injury and demonstrate the usefulness of process measures in rehabilitation.

Conditions

Traumatic Brain Injury; Stroke

Keywords

Brain injury; stroke; cognitive rehabilitation

Outcome Measures

Primary Outcomes (2)

• Paced auditory Serial Attention Test (PASAT)

  Primary endpoint for the acute phase The primary endpoint was performance in the attention measure PASAT after 20 hours of APT training expressed as the number of correct responses.

  change from baseline after each 3 treatment sessions, change from baseline after 20 hours of training, change from baseline after 6 months and change from baseline after 1 year

• Work Ability Index (WAI)

  Primary endpoint for the subacute phase The primary endpoint was the score in the WAI measure expressed as the degree of subjective work ability.

  change from baseline after 20 hours of training, change from baseline after 3 months and change from baseline after 1 year

Secondary Outcomes (15)

• Digit Span

  after 20 hours of training, after 6 months and after 1 year

• The Block Span

  after 20 hours of training, after 6 months, after 1 year

• The Ruff 2&7 Selective Attention Test

  after 20 hours of training, after 6 months, after 1 year

• The Letter-Number Sequencing task

  after 20 hours of training, after 6 months and after 1 year

• The Trail Making Test (TMT)

  after 20 hours of training, after 6 months and after 1 year

Other Outcomes (1)

• Quality Adjusted Life Years (QUALYs)

  after one year

Study Arms (2)

attention training acute

EXPERIMENTAL

20 hours of attention training, APT training, or multiprofessional rehabilitation

Behavioral: APT training; Behavioral: Multiprofessional rehabilitation

attention training subacute

EXPERIMENTAL

20 hours of attention training, APT training, or multiprofessional rehabilitation

Behavioral: APT training; Behavioral: Multiprofessional rehabilitation

Interventions

APT training BEHAVIORAL

APT training was used as intensive area-specific cognitive training at four levels: sustained, selective, divided and alternating attention. The APT also includes education in acquired attention deficits and training for generalization. Each session took 45-90 minutes to perform. The APT-test was used to determine the level of difficulty for the attention training.

attention training acute; attention training subacute

Multiprofessional rehabilitation BEHAVIORAL

Attention training in activities included standard occupational training within an interdisciplinary rehabilitation programme. The programme consisted of training and the use of compensatory strategies in attention-demanding activities of daily living, performing independent work with attention-demanding tasks at individual level and group activities

attention training acute; attention training subacute

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• mild to moderate stroke
• traumatic brain-injury
• deficits in attention defined by the APT test
• lower average and above for reasoning skills
• lower average and above for abstract thinking
• good understanding of the Swedish language

You may not qualify if:

• moderate to severe aphasia
• ongoing psychiatric illness
• history of severe somatic disorder causing anoxic periods
• ongoing substance abuse
• severe pain severe memory disorders,
• neglect
• visual field defects
• motor disability interfering with participation

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator
• Promobilia Foundation: collaborator
• Stroke Foundation: collaborator
• KID-medel: collaborator

Study Sites (1)

Dept medical rehabilitation Danderyd hospital

Stockholm, 18288, Sweden

Location

Related Publications (1)

• Bartfai A, Markovic G, Sargenius Landahl K, Schult ML. The protocol and design of a randomised controlled study on training of attention within the first year after acquired brain injury. BMC Neurol. 2014 May 8;14:102. doi: 10.1186/1471-2377-14-102.

  PMID: 24885585 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aniko Bartfai, PhD

  Karolinska institutet, KIDS

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 19, 2014
• Study Start: January 1, 2009
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: September 3, 2015

Record last verified: 2015-09

Locations

SE (1)