http://www.trialsjournal.com/content/pdf/1745-6215-14-306.pdf
Abstract
Background
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.
Methods/design
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 video tapes 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.
Discussion
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.
Trial registration
Clinical Trials.gov, Trial Identification Number: NCT01414348
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