Managing Dysexecutive Syndrome (DS): CIHR 2011-2014
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Traumatic Brain Injury Cerebrovascular Accident (CVA) Acquired Brain Injury |
Behavioral: Conventional rehabilitation. Behavioral: Novel rehabilitation approach |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Managing the Dysexecutive Syndrome Following Traumatic Brain Injury: An Ecologically Valid Rehabilitation Approach |
- Change in performance on COPM [ Time Frame: pre, post, 3 month follow-up ] [ Designated as safety issue: No ]Canadian Occupational Performance Measure: standardized interview
- DEX, IADL profile [ Time Frame: pre, post, 3 month follow-up ] [ Designated as safety issue: No ]Perceived and observed impact of dysexecutive syndrome in everyday life
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Conventional rehabilitation
In-home work on problems in daily living.
|
Behavioral: Conventional rehabilitation.
1 hour / 2x / week for up to 15 sessions
|
| Experimental: Novel rehabilitation approach |
Behavioral: Novel rehabilitation approach
1 hr, 2x/week for up to 15 sessions
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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,
- have no report of other significant neurological or psychiatric history such as multiple sclerosis or psychiatric illness requiring hospitalization, concurrent moderate to severe depression.
Exclusion Criteria:
Contacts and Locations| Contact: Pratika Bandari, BSc | 416-785-2500 ext 3377 | pbandari@research.baycrest.org |
| Canada, Ontario | |
| Baycrest Centre for Geriatric Care | Recruiting |
| Toronto, Ontario, Canada, M6A2E1 | |
| Contact: Deirdre D Dawson, PhD 416-785-2500 ext 2136 ddawson@research.baycrest.org | |
| Principal Investigator: | Deirdre D Dawson, PhD | Baycrest centre |
More Information
No publications provided
| Responsible Party: | Deirdre Dawson, Dr. Deirdre Dawson, Senior Scientist Rotman Research Institute, Baycrest |
| ClinicalTrials.gov Identifier: | NCT01414348 History of Changes |
| Other Study ID Numbers: | REB1120 |
| Study First Received: | August 10, 2011 |
| Last Updated: | November 1, 2012 |
| Health Authority: | Canada: Ethics Review Committee Canada: Canadian Institutes of Health Research |
Keywords provided by Baycrest:
|
participation activities of daily living brain injuries executive function |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Brain Injuries Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013