Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR) Treatment Approach for Stroke

This study is currently recruiting participants.
Verified July 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01910454
First received: July 22, 2013
Last updated: July 30, 2013
Last verified: July 2013

July 22, 2013
July 30, 2013
August 2012
May 2014   (final data collection date for primary outcome measure)
  • Canadian Occupational Performance Measure (COPM) [ Time Frame: Change from baseline to post-intervention (12 weeks) ] [ Designated as safety issue: No ]
  • Performance Quality Rating Scale (PQRS) [ Time Frame: Change from baseline to post-intervention (12 weeks) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01910454 on ClinicalTrials.gov Archive Site
  • Reintegration to Normal Living Index (RNLI) [ Time Frame: Change from baseline to post-intervention (12 weeks) ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes Measurement System (PROMIS-57) [ Time Frame: Change from baseline to post-intervention (12 weeks) ] [ Designated as safety issue: No ]
  • Stroke Impact Scale (SIS) [ Time Frame: Change from baseline to post-intervention (12 weeks) ] [ Designated as safety issue: No ]
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: Change from baseline to post-intervention (12 weeks) ] [ Designated as safety issue: No ]
  • Self-Efficacy Gauge (SEG) [ Time Frame: Change from baseline to post-intervention (12 weeks) ] [ Designated as safety issue: No ]
  • Activity Card Sort (ACS) [ Time Frame: Change from baseline to post-intervention (12 weeks) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR) Treatment Approach for Stroke
COGNITIVE ORIENTED STRATEGY AUGMENTED REHABILITATION (COSTAR) FOR STROKE

Stroke is the most serious disabling condition in the United States and the developed world. Novel stroke rehabilitation approaches, such as task-specific training, have shown promise in improving an individual's recovery in the rehabilitation setting; however, evidence suggests that these improvements are not generalized or transferred to the home, community, or work settings. Thus, these interventions usually do not impact overall health and participation outcomes. This research study seeks to improve task-specific training as a stroke rehabilitation approach by integrating it with evidence-based cognitive-oriented strategies which have shown great promise as a way to address the limitations of task-specific training. The new treatment protocol is called Cognitive-Oriented Strategy Training Augmented Rehabilitation, or COSTAR. The hypothesis of this study is that COSTAR will result in more efficient functional skill acquisition, better long-term retention of skills learned, and generalization and transfer of skills learned to home, community, and work settings.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • Behavioral: Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)
    The protocol for COSTAR is based on the Cognitive-Orientation to daily Occupational Performance Intervention (CO-OP) approach which includes the following components: (1) Guided discovery - a process created by CO-OP to make certain that participants discover the strategies that will solve their own performance problems ; (2) Cognitive strategy use - participants are taught a global problem-solving strategy and are enabled to discover additional domain specific strategies that will support their skill acquisition and performance competence; and (3) Dynamic performance analysis - an observation-based process of identifying performance problems or performance breakdown. These three components from CO-OP are overlaid on the TST intervention protocol described above to address the overall hypothesis of this study: that an evidence-based stroke rehabilitation treatment protocol (task-specific training) can be enhanced when augmented with the catalyst of cognitive-oriented strategy use.
  • Behavioral: Task Specific Training (TST)
    The protocol for task-specific training is based on criteria established by Winstein and Wolf (2008) who define task-specific training (TST) as a top-down approach to rehabilitation that is based on recent integrated models of motor control, motor learning, and behavioral neuroscience and that addresses skill acquisition of performance of meaningful and relevant tasks (Winstein and Wolf, 2008). Winstein and Wolf use current theory to identify three key ingredients for a task-specific training (pg 269): (1) Challenging enough to require new learning, and engagement with attention to solve the motor problem; (2) Progressive and optimally adapted such that over practice, the task-demand is optimally adapted to the patient's capability and the environmental context. The task should not be too simple or too repetitive nor too difficult; and (3) Interesting enough to invoke active participation through engagement in meaningful activity.
    Other Names:
    • Task Oriented Training
    • Specific Task Training
  • Experimental: Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)
    Intervention: Behavioral: Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)
  • Active Comparator: Task Specific Training (TST)
    Intervention: Behavioral: Task Specific Training (TST)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. age 18 or older;
  2. have completed all physician recommended rehabilitation and currently not receiving rehabilitation services;
  3. at least one-month post-stroke;
  4. have self-reported unmet functional goals; and
  5. NIH Stroke Scale (NIHSS) total score of 2-12.

Exclusion Criteria:

  1. have sustained a hemorrhagic stroke;
  2. NIH Stroke Scale (NIHSS) aphasia rating of 1 or more (impaired speech);
  3. MoCA cognitive screen score of less than 21 (impaired general cognitive ability);
  4. neurological diagnoses other than stroke;
  5. major psychiatric illness (bipolar disorder, OCD, panic disorder, PTSD, and/or borderline personality disorder);
  6. no major depressive symptoms (PHQ-9 < 20);
  7. a score of 6 or less on the CIHI aphasia screen combined items 64 and 66;
  8. terminal illness;
  9. blindness; and
  10. non-English speaking.
Both
18 Years and older
No
Contact: Timothy J Wolf, OTD, MSCI, OTR/L 314-286-1683 wolft@wustl.edu
United States
 
NCT01910454
R03HD069626
No
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Timothy J Wolf, OTD, MSCI, OTR/L Washington University School of Medicine
Washington University School of Medicine
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP