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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Stroke
Behavioral: Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)
Behavioral: Task Specific Training (TST)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: COGNITIVE ORIENTED STRATEGY AUGMENTED REHABILITATION (COSTAR) FOR STROKE

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 36
Study Start Date: August 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR) 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.
Active Comparator: Task Specific Training (TST) 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01910454

Contacts
Contact: Timothy J Wolf, OTD, MSCI, OTR/L 314-286-1683 wolft@wustl.edu

Locations
United States, Missouri
Washington University in St Louis: Program in Occupational Therapy Recruiting
St Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Timothy J Wolf, OTD, MSCI, OTR/L Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01910454     History of Changes
Other Study ID Numbers: R03HD069626
Study First Received: July 22, 2013
Last Updated: July 30, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Stroke
Occupational Therapy
Cognition

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 16, 2014