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Clinical Trials/NCT01910454
NCT01910454
Completed
Phase 1

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

Washington University School of Medicine1 site in 1 country47 target enrollmentAugust 2013
ConditionsStroke

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Stroke
Sponsor
Washington University School of Medicine
Enrollment
47
Locations
1
Primary Endpoint
Canadian Occupational Performance Measure (COPM)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
March 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • have sustained a hemorrhagic stroke;
  • NIH Stroke Scale (NIHSS) aphasia rating of 1 or more (impaired speech);
  • MoCA cognitive screen score of less than 21 (impaired general cognitive ability);
  • neurological diagnoses other than stroke;
  • major psychiatric illness (bipolar disorder, OCD, panic disorder, PTSD, and/or borderline personality disorder);
  • no major depressive symptoms (PHQ-9 \< 20);
  • a score of 6 or less on the CIHI aphasia screen combined items 64 and 66;
  • terminal illness;
  • blindness; and
  • non-English speaking.

Outcomes

Primary Outcomes

Canadian Occupational Performance Measure (COPM)

Time Frame: Change from baseline to post-intervention (12 weeks)

Performance Quality Rating Scale (PQRS)

Time Frame: Change from baseline to post-intervention (12 weeks)

Secondary Outcomes

  • Self-Efficacy Gauge (SEG)(Change from baseline to post-intervention (12 weeks))
  • Activity Card Sort (ACS)(Change from baseline to post-intervention (12 weeks))
  • Reintegration to Normal Living Index (RNLI)(Change from baseline to post-intervention (12 weeks))
  • Stroke Impact Scale (SIS)(Change from baseline to post-intervention (12 weeks))
  • Patient Reported Outcomes Measurement System (PROMIS-57)(Change from baseline to post-intervention (12 weeks))
  • Patient Health Questionnaire (PHQ-9)(Change from baseline to post-intervention (12 weeks))

Study Sites (1)

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