Managing Dysexecutive Syndrome (DS): CIHR 2011-2014

Study Overview
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Brief Summary
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Successful community participation following acquired brain injury (ABI) continues to be an elusive goal for patients, clinicians and researchers. Our pilot work shows that community dwelling survivors of ABI can significantly improve performance on self-identified real- world performance problems and that they can transfer this learning to improve goals not trained in the treatment sessions. We will compare two types of rehabilitation intervention using a randomized controlled trial. We will also interview survivors, their significant others and clinicians regarding their experiences with each intervention to help us discover what works best.

Detailed Description
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Executive dysfunction is endemic after severe acquired brain injuries (ABIs) and is highly associated with long-lasting psychosocial distress, problems in a multiplicity of everyday activities and overall reduced quality of life. There is increasing evidence to suggest that a novel behavioral intervention is a treatment of choice for executive dysfunction. However few studies have addressed ecological relevance: failing to take into account the significant impact of the complex settings of real life on executive function. More data are desperately needed in this area given the devastating consequences of ABI. We propose to investigate the benefits of two community- based interventions.

Official Title
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Managing the Dysexecutive Syndrome Following Traumatic Brain Injury: An Ecologically Valid Rehabilitation Approach

Conditions
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Traumatic Brain Injury, Cerebrovascular Accident (CVA), Acquired Brain Injury

Intervention / Treatment
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* Behavioral: Conventional rehabilitation.
* Behavioral: Novel rehabilitation approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fluent in written and spoken English, have sustained (1) a moderate to severe TBI as defined by a 6-hour GCS of 12 or less OR (2) complicated mild TBI with GCS 13-15 and associated abnormal findings on CT or MRI scan OR (3) other form of acquired brain injury (ABI) that is not related to a congenital, developmental or degenerative disorder but which occurred through a medical problem or disease process including stroke, Exclusion Criteria: other significant neurological or psychiatric history such as multiple sclerosis or psychiatric illness requiring hospitalization, concurrent moderate to severe depression.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional rehabilitation<br>In-home work on problems in daily living. | Behavioral: Conventional rehabilitation.<br>* 1 hour / 2x / week for up to 15 sessions<br>|
| Experimental: Novel rehabilitation approach<br> | Behavioral: Novel rehabilitation approach<br>* 1 hr, 2x/week for up to 15 sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in performance on COPM | Canadian Occupational Performance Measure: standardized interview | pre, post, 3 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DEX, IADL profile | Perceived and observed impact of dysexecutive syndrome in everyday life | pre, post, 3 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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participation, activities of daily living, brain injuries, executive function