N/A
N=30
CO-OPerative Training for Stroke Rehabilitation
CO-OP · Attention Control
Bottom Line
View on ClinicalTrials.gov: NCT02755805 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time — 65.27; 62.60; 86.80; 80.53 units on a scale — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CO-OP (Behavioral); Attention Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time |
65.27; 62.60; 86.80; 80.53; 109.69; 91.23 | 0.007 sig |
| SECONDARY Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale) |
4.85; 4.00; 8.73; 4.40; 8.20; 3.67 | 0.09 |
| SECONDARY Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale) |
3.69; 2.73; 8.82; 3.00; 8.20; 2.78 | .002 sig |
| SECONDARY Differences in Apathy Symptoms Between Groups Over Time |
25.79; 25.18; 25.18; 34.13; 21.38; 29.00 | .04 sig |
Summary
Cognitive impairments occur frequently after stroke, and are associated with significant long-term activities of daily living (ADL) disability and poor quality of life. This research study will undertake an innovative approach addressing cognitive impairments, by examining a new patient-centered functionally-relevant rehabilitation intervention that teaches individuals with cognitive impairments to manage their deficits to reduce ADL disability.
Eligibility Criteria
Inclusion Criteria
- primary diagnosis of acute stroke
- admission to acute inpatient rehabilitation
- impairment in cognitive functions (Quick Executive Interview ≥ 3)
Exclusion Criteria
- dementia diagnosis (as indicated in the medical record)
- severe aphasia as indicated by score ≥ 2 on the Boston Diagnostic Aphasia Examination (3rd Edition) Severity Rating Scale (BDAE-3)
- current major depressive disorder (unless treated and in partial remission), bipolar or any other psychotic disorder (Primary Care Evaluation of Mental Disorders)
- drug or alcohol abuse within 3 months (Mini-International Neuropsychiatric Interview)
- anticipated length of stay less than 5 days
Data sourced from ClinicalTrials.gov (NCT02755805). 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.