Clinical trial NCT01910454: Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR) Treatment Approach for Stroke
Official title: Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR) Treatment Approach for Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Keywords: Stroke
Occupational Therapy
Cognition
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-07-29
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Change from baseline to post-intervention (12 weeks)
measure: Performance Quality Rating Scale (PQRS)
timeFrame: Change from baseline to post-intervention (12 weeks)
Secondary outcomes:
measure: Reintegration to Normal Living Index (RNLI)
timeFrame: Change from baseline to post-intervention (12 weeks)
measure: Patient Reported Outcomes Measurement System (PROMIS-57)
timeFrame: Change from baseline to post-intervention (12 weeks)
measure: Stroke Impact Scale (SIS)
timeFrame: Change from baseline to post-intervention (12 weeks)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline to post-intervention (12 weeks)
measure: Self-Efficacy Gauge (SEG)
timeFrame: Change from baseline to post-intervention (12 weeks)
measure: Activity Card Sort (ACS)
timeFrame: Change from baseline to post-intervention (12 weeks)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St Louis: Program in Occupational Therapy
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Timothy J Wolf, OTD, MSCI, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winstein, Carolee J, & Wolf, Steven L. (2009). Task-oriented training to promote upper extremity recovery. Stroke Recovery & Rehabilitation, 267-290.