Clinical trial NCT02755805: CO-OPerative Training for Stroke Rehabilitation
Official title: CO-OPerative Training For Stroke Rehabilitation: A Phase II Trial Examining Meta-Cognitive Strategy Training in Acute Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CO-OP
Attention Control
Keywords: Stroke
Rehabilitation
Cognition
Intervention
Strategy training
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Cognitive impairments are characterized by problems sustaining attention in distracting conditions, shifting attention between different task demands, and using working memory to consistently execute intended actions, and as a result limit the ability to execute routine ADLs. Presently there are no interventions that have demonstrated robust effectiveness in reducing disability among individuals with cognitive impairments after stroke. Recent findings suggest that individuals with cognitive impairments may experience ADL disability in part because they have difficulty engaging in, and benefiting from rehabilitation programs as they are currently delivered. In other words, individuals with cognitive impairment, due to the nature of their impairments, have difficulty learning and applying adaptive strategies as they are currently provided during traditional rehabilitation training. Therefore, interventions that train individuals with cognitive impairments a new way to learn and apply adaptive strategies may help them benefit from rehabilitation programs and reduce long-term disability. Cognitive Orientation to daily Occupation Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Therefore, CO-OP teaches individuals to "take charge" of their rehabilitation, and develop adaptive behaviors to "work around" cognitive impairments to meet their goals. The proposed project examines whether CO-OP facilitates reductions in ADL disability and improvements in rehabilitation engagement among individuals with cognitive impairments after acute stroke.

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

Primary outcomes:
measure: Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
timeFrame: Baseline, rehabilitation discharge, month 3, month 6
Secondary outcomes:
measure: Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale)
timeFrame: Baseline, 3 months, 6 months
measure: Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale)
timeFrame: Baseline, 3 months, 6 months
measure: Differences in Apathy Symptoms Between Groups Over Time
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Elizabeth R Skidmore, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kringle EA, Terhorst L, Butters MA, Skidmore ER. Clinical Predictors of Engagement in Inpatient Rehabilitation Among Stroke Survivors With Cognitive Deficits: An Exploratory Study. J Int Neuropsychol Soc. 2018 Jul;24(6):572-583. doi: 10.1017/S1355617718000085. Epub 2018 Mar 19.