Examining Rehabilitation Training Methods

Not Applicable

Completed

• Conditions: Guided Training; Directed Training

• Registration Number: NCT02766400
• Lead Sponsor: University of Pittsburgh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2014-12
• Study Completion: 2015-07
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-06
• Study First Posted: 2016-05-09
• Results First Submitted: 2016-07-08
• Results First Submitted QC: 2016-08-27
• Results First Posted: 2016-10-20
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States