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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD074693 | U.S. NIH Grant/Contract | View source |
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Given the design of the study, we reached saturation with a sample of 16
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strategy Training | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strategy Training | Behavioral | This study will use an adapted form of strategy training for people with communication impairments. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Post-Intervention (up to 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth R. Skidmore, PhD, OTR/L | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Post-Intervention (up to 3 weeks) |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Skidmore | University of Pittsburgh | (412) 383-6617 | skidmore@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 22, 2021 | Jun 10, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2021 | Jun 10, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 28, 2020 | Jun 10, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Baseline to 6 months |
| 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). | Baseline to 6 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Comorbidity, Charlson Comorbidity Index | Comordity severity (measured with the Charlson Comorbidity Index) assesses the presence of 21 comorbid conditions using a scale of 0 (absent) to 1 (present) for each condition. Total scores range from 0 to 21. Higher values represent more severe comorbidity. | Mean | Standard Deviation | total score |
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| Chronicity, Days since stroke | Mean | Standard Deviation | days |
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| Stroke Hemisphere, Left | Number | participants |
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| Inpatient Rehabilitation Length of Stay, Days | Mean | Standard Deviation | days |
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| Aphasia Severity, Boston Diagnostic Aphasia Examination Severity Scale | Aphasia severity (measured with the Boston Diagnostic Aphasia Examination Severity Scale) is assessed using a single scale of 0 (no usable speech or auditory comprehension) to 5 (minimal discernible speech impairments; subjective difficulties not apparent to listener). Higher values represent lower aphasia severity. | Mean | Standard Deviation | total score |
|
| Stroke Severity, National Institutes of Health Stroke Scale | Stroke severity (measured with the National Institutes of Health Stroke Scale) is assessed through 15 items addressing a range of neurological impairments that emerge after stroke (cognition, motor function, sensory function, language, perception). The total score ranges from 0 (no neurological impairment) to 42 (severe neurological impairment). Higher values represent greater stroke severity. | Mean | Standard Deviation | total score |
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| Disability, Functional Independence Measure | Disability (measured with the Functional Independence Measure) is assessed through 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. | Mean | Standard Deviation | total score |
|
| Cognitive Linguistic Quick Test Executive Function Score | Cognition (measured with the Cognitive Linguistic Quick Test Executive Function Score) is measured with 4 tasks (symbol trails, generative naming, mazes, and design generation). The severity score ranges from 40 (within normal limits) to 0 (severe impairment). Higher values represent better outcomes. | Mean | Standard Deviation | composite score |
|
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| 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). | Posted | Mean | Standard Deviation | change score on a scale | Baseline to 6 months |
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|
|
| 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). | Posted | Mean | Standard Deviation | composite score | Baseline to 6 months |
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| 1 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |