N/A
N=43
Examining Rehabilitation Training Methods
Guided Training · Directed Training
Bottom Line
View on ClinicalTrials.gov: NCT02766400 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time — 67.33; 67.32; 86.86; 89.05 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Guided Training (Behavioral); Directed Training (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time |
67.33; 67.32; 86.86; 89.05; 105.32; 102.55 | <0.001 sig |
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.
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)
Data sourced from ClinicalTrials.gov (NCT02766400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.