Clinical trial NCT03593876: Strategy Training for People With Aphasia After Stroke
Official title: Strategy Training for People With Aphasia After Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Strategy Training
Keywords: Stroke
Aphasia
Rehabilitation
Cognition
Disability
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-07-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: One-third to one-half of acute strokes result in newly acquired cognitive impairments. Approximately 30 to 40% of people in the acute phase of stroke also sustain communication impairments. Stroke-related cognitive impairments are associated with significant functional disability, as indicated by the inability to regain independence in daily activities. The overall aim of this study is to examine the feasibility of an adapted form of strategy training for people with communication impairments who are admitted to inpatient rehabilitation. These analyses will address a critical gap in current rehabilitation research, namely the exclusion of people with communication impairments in acute stroke rehabilitation clinical trials, and provide pilot data to inform the design of future inclusive clinical trials seeking to reduce disability after stroke.

Detailed description: This pilot study will use a descriptive case series design with repeated measures to assess the feasibility of an adapted form of strategy training for people with communication impairments after acute stroke. The investigators will recruit people with aphasia due to stroke admitted to the inpatient rehabilitation units and administer the adapted form of strategy training one session per day 5 days per week for 10-15 sessions. The investigators will assess the feasibility of the intervention based on feedback from participants and therapists. These data will serve as pilot data to inform the design of a future clinical trials for people with cognitive impairments after stroke, including people with communication impairments. These efforts will allow the investigators to test new models to support optimal interventions for individuals with stroke-related cognitive impairments, including people with communication impairments who are among those most vulnerable for long-term disability.

Eligibility criteria: Inclusion Criteria:

* primary diagnosis of acute stroke
* admission to acute rehabilitation
* mild to moderate aphasia but able to understand and express communication with verbal, written, and/or augmentative communication (score of 1 or 2 on the National Institutes of Health Stroke Scale item 9, or score 1 to 5 on the Boston Diagnostic Aphasia Examination Severity Scale)

Exclusion Criteria:

* pre-stroke diagnosis of dementia
* severe global aphasia (Boston Diagnostic Aphasia Examination Severity Scale score of 0)
* dysarthria as the only communication impairment (score of 1 or 2 two on the National Institutes of Health Stroke Scale item 10, but score of 0 on item 9)
* current major depressive disorder (unless treated and in partial remission), bipolar disorder, or any other psychotic disorder (indicated by PRIME-MD)severe global aphasia (Boston Diagnostic Aphasia Examination Severity Scale score of 0)

Primary outcomes:
measure: Mean Patient-therapist Communication Score
timeFrame: Baseline to Post-Intervention (up to 3 weeks)
Secondary outcomes:
measure: Change in Independence With Daily Activities
timeFrame: Baseline to 6 months
measure: Change in Cognition
timeFrame: Baseline to 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: