Managing executive dysfunction following acquired brain injury and stroke using an ecologically valid rehabilitation approach: a study protocol for a randomized, controlled trial
1 Rotman Research Institute, Baycrest, 3560 Bathurst Street, Toronto, ON M6A 2E1, Canada
2 Department of Occupational Science and Occupational Therapy, University of Toronto, Suite 160-500 University Avenue, Toronto, ON M5G 1V7, Canada
3 Graduate Department of Rehabilitation Sciences, University of Toronto, Suite 160-500 University Avenue, Toronto, ON M5G 1V7, Canada
4 Center for Interdisciplinary Research in Rehabilitation of Greater Montreal, 2275 avenue Laurier Est, Montreal, Quebec H2H 2N8, Canada
5 School of Social Work, University of Windsor, 401 Sunset Ave, Windsor, ON N9B 3P4, Canada
6 Kunin-Lunenfeld Applied and Evaluative Research Unit, Baycrest, 3560 Bathurst Street, Toronto, ON M6A 2E1, Canada
7 Schulich School of Medicine and Dentistry, University of Western Ontario, 245-100 Collip Circle, Research Park, London, ON N6G 4X8, Canada
Trials 2013, 14:306 doi:10.1186/1745-6215-14-306Published: 22 September 2013
We have been investigating an ecologically valid strategy-training approach to enable adults with executive dysfunction to attain everyday life goals. Here, we report the protocol of a randomized controlled trial of the effects of this training compared to conventional therapy in a sample of community-dwelling adults with acquired brain injury and/or stroke.
We will recruit 100 community-dwelling survivors at least six months post-acquired brain injury or stroke who report executive dysfunction during a telephone interview, confirmed in pre-training testing. Following pre-training testing, participants will be randomized to the ecologically valid strategy training or conventional therapy and receive two one-hour sessions for eight weeks (maximum of 15 hours of therapy). Post-testing will occur immediately following the training and three months later. The primary outcome is self-reported change in performance on everyday life activities measured using the Canadian Occupational Performance Measure, a standardized, semi-structured interview. Secondary outcomes are objective measurement of performance change from videotapes of treatment session, Performance Quality Rating Scale; executive dysfunction symptoms, Behavioural Rating Inventory of Executive Function – Adult; participation in everyday life, Mayo-Portland Adaptability Inventory Participation Index; and ability to solve novel problems, Instrumental Activities of Daily Living Profile.
This study is of a novel approach to promoting improvements in attainment of everyday life goals through managing executive dysfunction using an ecologically valid strategy training approach, the Cognitive Orientation to daily Occupational Performance. This study compares the efficacy of this approach with that of conventional therapy. The approach has the potential to be a valuable treatment for people with chronic acquired brain injury and/or stroke.
clinicaltrials.gov, Trial Identification Number: NCT01414348