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| ID | Type | Description | Link |
|---|---|---|---|
| R03HD073770-01 | U.S. NIH Grant/Contract | View source | |
| R01HD074693-02S1 | U.S. NIH Grant/Contract | View source | |
| UL1TR000005 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. This loss of independence is costly because individuals with stroke-related cognitive impairments require more rehabilitation and more resources to support their living, whether in institutional or community settings. The proposed study examines the effects of directed and guided training on the recovery of independence with daily activities in adults with stroke-related cognitive impairments in acute rehabilitation. The investigators predict that patients in both groups will demonstrate significant improvement in independence with daily activities in the first 12 months after rehabilitation admission, but that patients who receive guided training will demonstrate significantly more improvements than patients who received directed training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guided Training | Experimental | Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with "practical" skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence. |
|
| Directed Training | Active Comparator | Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided Training | Behavioral |
|
| |
| Directed Training |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Differences between groups in mean independence scores (computed from Functional Independence Measure total scores) over time. The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated for each participant at baseline, discharge, month 3, month 6, and month 12, and mean total scores for each group were calculated at each time point. Differences in mean scores were examined between groups over time with mixed model analyses. | Baseline, rehab discharge, month 3, month 6, month 12 |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29552996 | Derived | 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. | |
| 27794487 | Derived | Skidmore ER, Butters M, Whyte E, Grattan E, Shen J, Terhorst L. Guided Training Relative to Direct Skill Training for Individuals With Cognitive Impairments After Stroke: A Pilot Randomized Trial. Arch Phys Med Rehabil. 2017 Apr;98(4):673-680. doi: 10.1016/j.apmr.2016.10.004. Epub 2016 Oct 26. |
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At present, there is no plan to share data.
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Excluded (n=27)
Withdrew prior to randomization (n=7)
Recruitment period: August 2012 to December 2014. Participants with acute stroke were enrolled in inpatient rehabilitation at Mercy and Montefiore Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Guided Training | Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with "practical" skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence. Guided Training |
| FG001 | Directed Training | Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation. Directed Training |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Guided Training | Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with "practical" skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence. Guided Training |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time | Differences between groups in mean independence scores (computed from Functional Independence Measure total scores) over time. The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated for each participant at baseline, discharge, month 3, month 6, and month 12, and mean total scores for each group were calculated at each time point. Differences in mean scores were examined between groups over time with mixed model analyses. | Posted | Mean | Standard Error | units on a scale | Baseline, rehab discharge, month 3, month 6, month 12 |
|
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 | Guided Training | Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with "practical" skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence. Guided Training |
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Both interventions were offered in addition to usual care (comprised mostly of direct skill training). This may have minimized the overall effect of guided training.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth R. Skidmore, PhD, OTR/L, FAOTA | University of Pittsburgh | (412) 383-6617 | skidmore@pitt.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Behavioral |
|
|
| BG001 | Directed Training | Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation. Directed Training |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Stroke onset | Stroke onset is calculated from date of stroke to date of study admission. | Mean | Standard Deviation | days |
|
| Stroke type | Number | participants |
|
| Hemisphere | Number | participants |
|
| Stroke severity, NIHSS | The NIHSS is composed of 11 items that are summed to yield a total score. Total scores range from 0 to 42, where 0=no neurological impairment, and 42=severe neurological impairment. | Mean | Standard Deviation | units on a scale |
|
| Cognitive status, EXIT | The EXIT is composed of 14 items that are summed to yield a total score ranging from 0 to 28. A total score of 0 typically indicates no executive impairment, while a total score of 28 indicates severe executive impairment. | Mean | Standard Deviation | units on a scale |
|
| Functional Independence Measure | The Functional Independence Measure contains 18 items composed of 13 motor tasks and 5 cognitive tasks. A total score of 18-126 is obtained where 18 represents complete dependence/total assistance and 126 represents complete independence with daily activities. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Directed Training | Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation. Directed Training |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Directed Training | Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation. Directed Training | 0 | 22 | 0 | 22 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |