Managing Dysexecutive Syndrome (DS): CIHR 2011-2014

Not Applicable

Completed

• Conditions: Cerebrovascular Accident (CVA); Traumatic Brain Injury; Acquired Brain Injury
• Interventions: Behavioral: Novel rehabilitation approach; Behavioral: Conventional rehabilitation.

• Registration Number: NCT01414348
• Lead Sponsor: Baycrest

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Study Start: 2012-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Novel rehabilitation approach	Novel rehabilitation approach	-
Conventional rehabilitation	Conventional rehabilitation.	In-home work on problems in daily living.

Primary Outcome Measures

Name	Time	Method
Change in performance on COPM	pre, post, 3 month follow-up	Canadian Occupational Performance Measure: standardized interview

Secondary Outcome Measures

Name	Time	Method
DEX, IADL profile	pre, post, 3 month follow-up	Perceived and observed impact of dysexecutive syndrome in everyday life

Trial Locations

Locations (1)

Baycrest Centre for Geriatric Care; 🇨🇦 Toronto, Ontario, Canada