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Clinical Trials/NCT02766400
NCT02766400
Completed
N/A

Guided Versus Directed Training in Acute Stroke Rehabilitation

University of Pittsburgh1 site in 1 country77 target enrollmentAugust 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Guided Training
Sponsor
University of Pittsburgh
Enrollment
77
Locations
1
Primary Endpoint
Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
Status
Completed
Last Updated
6 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. This loss of independence is costly because individuals with stroke-related cognitive impairments require more rehabilitation and more resources to support their living, whether in institutional or community settings. The proposed study examines the effects of directed and guided training on the recovery of independence with daily activities in adults with stroke-related cognitive impairments in acute rehabilitation. The investigators predict that patients in both groups will demonstrate significant improvement in independence with daily activities in the first 12 months after rehabilitation admission, but that patients who receive guided training will demonstrate significantly more improvements than patients who received directed training.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
July 2015
Last Updated
6 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 cognitive functions (as indicated by 14-item Executive Interview ≥ 3)

Exclusion Criteria

  • diagnosis of dementia in the medical record
  • inability to follow two-step commands 80% of the time
  • severe aphasia (score of 0 or 1 on the Boston Diagnostic Aphasia Examination 3rd Edition Severity Rating Scale)
  • current untreated major depressive, bipolar, or psychotic disorder (PRIME-MD)
  • drug or alcohol abuse within 3 months (Mini-International Neuropsychiatric Interview)

Outcomes

Primary Outcomes

Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time

Time Frame: Baseline, rehab discharge, month 3, month 6, month 12

Differences between groups in mean independence scores (computed from Functional Independence Measure total scores) over time. The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated for each participant at baseline, discharge, month 3, month 6, and month 12, and mean total scores for each group were calculated at each time point. Differences in mean scores were examined between groups over time with mixed model analyses.

Study Sites (1)

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