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

Phase 1

Completed

• Conditions: Stroke
• Interventions: Behavioral: Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR); Behavioral: Task Specific Training (TST)

• Registration Number: NCT01910454
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-22
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-29
• Study Start: 2013-08
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-27
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)	Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)	-
Task Specific Training (TST)	Task Specific Training (TST)	-

Primary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure (COPM)	Change from baseline to post-intervention (12 weeks)
Performance Quality Rating Scale (PQRS)	Change from baseline to post-intervention (12 weeks)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Washington University in St Louis: Program in Occupational Therapy; 🇺🇸 Saint Louis, Missouri, United States