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Clinical Trials/NCT01934621
NCT01934621
Completed
Not Applicable

Closing the Gap: Early Intervention for Cognitive Disability After Stroke

University of Pittsburgh1 site in 1 country128 target enrollmentNovember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Strategy Training
Sponsor
University of Pittsburgh
Enrollment
128
Locations
1
Primary Endpoint
Change in Independence with Daily Activities
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. The proposed study examines a novel intervention, strategy training, that shows promise for helping individuals with stroke-related cognitive impairments reduce disability in daily tasks, which may lead to reductions in healthcare costs. We predict that strategy training will result in significantly greater independence 6 months after stroke compared to an attention control intervention, and that strategy training may reduce cognitive impairments.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
September 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elizabeth R. Skidmore, PhD, OTR/L

Assistant Professor

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • primary diagnosis of acute stroke
  • admission to acute inpatient rehabilitation
  • impairment in higher order cognitive functions (EXIT-14 ≥ 3)

Exclusion Criteria

  • pre-stroke diagnosis of dementia in the medical record
  • inability to follow two- step commands 80% of the time
  • severe aphasia (BDAE ≤ 1)
  • current major depressive, bipolar, or psychotic disorder
  • drug or alcohol abuse within 3 months

Outcomes

Primary Outcomes

Change in Independence with Daily Activities

Time Frame: Baseline to Month 6

Moderate effect size of difference between groups in independence (measured with the Functional Independence Measure)

Secondary Outcomes

  • Change in Executive Functions(Baseline to Month 6)

Study Sites (1)

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