NCT01414348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

2.8 years

First QC Date

August 10, 2011

Last Update Submit

January 26, 2015

Conditions

Keywords

participationactivities of daily livingbrain injuriesexecutive function

Outcome Measures

Primary Outcomes (1)

  • Change in performance on COPM

    Canadian Occupational Performance Measure: standardized interview

    pre, post, 3 month follow-up

Secondary Outcomes (1)

  • DEX, IADL profile

    pre, post, 3 month follow-up

Study Arms (2)

Conventional rehabilitation

ACTIVE COMPARATOR

In-home work on problems in daily living.

Behavioral: Conventional rehabilitation.

Novel rehabilitation approach

EXPERIMENTAL
Behavioral: Novel rehabilitation approach

Interventions

1 hour / 2x / week for up to 15 sessions

Conventional rehabilitation

1 hr, 2x/week for up to 15 sessions

Novel rehabilitation approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baycrest Centre for Geriatric Care

Toronto, Ontario, M6A2E1, Canada

Location

Related Publications (1)

  • Dawson DR, Anderson ND, Binns MA, Bottari C, Damianakis T, Hunt A, Polatajko HJ, Zwarenstein M. Managing executive dysfunction following acquired brain injury and stroke using an ecologically valid rehabilitation approach: a study protocol for a randomized, controlled trial. Trials. 2013 Sep 22;14:306. doi: 10.1186/1745-6215-14-306.

MeSH Terms

Conditions

Brain Injuries, TraumaticStrokeBrain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Deirdre D Dawson, PhD

    Baycrest centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Deirdre Dawson, Senior Scientist Rotman Research Institute

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 11, 2011

Study Start

March 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 27, 2015

Record last verified: 2015-01

Locations