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Managing Dysexecutive Syndrome (DS): CIHR 2011-2014

B

Baycrest

Status

Completed

Conditions

Traumatic Brain Injury
Cerebrovascular Accident (CVA)
Acquired Brain Injury

Treatments

Behavioral: Conventional rehabilitation.
Behavioral: Novel rehabilitation approach

Study type

Interventional

Funder types

Other

Identifiers

NCT01414348
REB1120

Details and patient eligibility

About

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.

Full 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.

Enrollment

95 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

95 participants in 2 patient groups

Conventional rehabilitation
Active Comparator group
Description:
In-home work on problems in daily living.
Treatment:
Behavioral: Conventional rehabilitation.
Novel rehabilitation approach
Experimental group
Treatment:
Behavioral: Novel rehabilitation approach

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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