Strategy Training
Conditions
Keywords
Stroke, Aphasia, Rehabilitation, Cognition, Disability
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.
Interventions
BEHAVIORALStrategy Training
This study will use an adapted form of strategy training for people with communication impairments.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Patient-therapist Communication Score | Baseline to Post-Intervention (up to 3 weeks) | Measure of Participation in Conversation (MPC) Interaction score greater than or equal to 2. The scale assesses the degree of participation executed by the participant with communication impairment during supported conversation. Scores range from 0=no participation/comprehension to 4=full participation/comprehension. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Independence With Daily Activities | Baseline to 6 months | Change in independence measured with the Functional Independence Measure. The FIM assesses 18 tasks in 6 functional domains (self-care, sphincter control, transfers, locomotion, communication and social cognition) using a scale of 1 (dependent) to 7 (independent). Scores range from 18 to 126. Higher values represent better outcomes. The a priori criterion for change was a medium effect size of change (Cohen's d≥0.5). |
| Change in Cognition | Baseline to 6 months | Change in cognition measured with the Cognitive Linguistic Quick Test Executive Function Score. The severity score measures executive functions using 4 tasks (symbol trails, generative naming, mazes, and design generation). The score ranges from 40 (within normal limits) to 0 (severe impairment). Higher values represent better outcomes. The a priori criterion for change was a medium effect size of change (Cohen's d≥0.5). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Strategy Training Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice.
Strategy Training: This study will use an adapted form of strategy training for people with communication impairments. Supported conversation principles will be standardized and incorporated into the intervention protocol. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Discharged home before intervention completion | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Strategy Training |
|---|---|
| Age, Continuous | 71.5 years STANDARD_DEVIATION 9.9 |
| Aphasia Severity, Boston Diagnostic Aphasia Examination Severity Scale | 1.9 total score STANDARD_DEVIATION 1.1 |
| Chronicity, Days since stroke | 25.6 days STANDARD_DEVIATION 27.6 |
| Cognitive Linguistic Quick Test Executive Function Score | 12.6 composite score STANDARD_DEVIATION 7.2 |
| Comorbidity, Charlson Comorbidity Index | 2.3 total score STANDARD_DEVIATION 1.7 |
| Disability, Functional Independence Measure | 52.4 total score STANDARD_DEVIATION 21 |
| Inpatient Rehabilitation Length of Stay, Days | 22.5 days STANDARD_DEVIATION 9.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 9 Participants |
| Stroke Hemisphere, Left | 13 participants |
| Stroke Severity, National Institutes of Health Stroke Scale | 8.6 total score STANDARD_DEVIATION 5.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Mean Patient-therapist Communication Score
Measure of Participation in Conversation (MPC) Interaction score greater than or equal to 2. The scale assesses the degree of participation executed by the participant with communication impairment during supported conversation. Scores range from 0=no participation/comprehension to 4=full participation/comprehension.
Time frame: Baseline to Post-Intervention (up to 3 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strategy Training | Mean Patient-therapist Communication Score | 3.0 score on a scale | Standard Deviation 1 |
Secondary
Change in Cognition
Change in cognition measured with the Cognitive Linguistic Quick Test Executive Function Score. The severity score measures executive functions using 4 tasks (symbol trails, generative naming, mazes, and design generation). The score ranges from 40 (within normal limits) to 0 (severe impairment). Higher values represent better outcomes. The a priori criterion for change was a medium effect size of change (Cohen's d≥0.5).
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strategy Training | Change in Cognition | 1.8 composite score | Standard Deviation 3.5 |
Comparison: The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess change scores and effect size of the change scores to compare with previously published clinical trials.
Secondary
Change in Independence With Daily Activities
Change in independence measured with the Functional Independence Measure. The FIM assesses 18 tasks in 6 functional domains (self-care, sphincter control, transfers, locomotion, communication and social cognition) using a scale of 1 (dependent) to 7 (independent). Scores range from 18 to 126. Higher values represent better outcomes. The a priori criterion for change was a medium effect size of change (Cohen's d≥0.5).
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strategy Training | Change in Independence With Daily Activities | 51.7 change score on a scale | Standard Deviation 21 |
Comparison: The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess change scores and effect size of the change scores to compare with previously published clinical trials.