| Primary | Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months | The Patient Health Questionnaire-9 is a screening tool for post-stroke depression and assessing the changes at baseline, 1, 3, and 6 months. The possible range is 0-27 and the higher scores mean worse outcomes. | Over 6 months, the numbers of patients lost to follow-up in the intervention and control groups were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months) | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 1, 3, and 6 months post intervention | | | | ID | Title | Description |
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| OG000 | Multi-intervention Program | A multi-intervention program was designed for intervention groups, including:
- Periodic health check program for post-stroke: The stroke survivors will be assessed for their physical and mental health, and harmful behaviors at 0, 1, 3, and 6 months by specific scales.
- Guiding the appropriate rehabilitation exercises: The appropriate rehabilitation exercises will be designed and guided for each patient and they will be followed up by the daily online report. This arm was performed in months 1+2 (once a week), months 3+4 (every 2 weeks), and months 5 + 6 (every 4 weeks).
- Motivational Interviewing will be conducted with post-stroke patients in the first month (once a week), the second month (every 2 weeks), and the third month (every 2 weeks). Each appointment will last for 1-2 hours. This intervention method aims to discover and resolve patients' conflicts through standardized communication skills to improve their mental health and change negative behaviors.
- Functional near-infrared spectroscopy: The fNIRS devices as an effective monitoring and therapeutic tool, evaluating the evolution of neural activity. Moreover, the cortex hemodynamic measure by fNIRS may detect early various mental disorders such as depression, fatigue, and schizophrenia... through cognitive tasks.
| | OG001 | Standard Care | The control group received the standard health check and fNIRS measure:
- Periodic health check program for post-stroke: The stroke survivors will be assessed for their physical and mental health, and harmful behaviors at 0, 1, 3, and 6 months by specific scales.
- Functional near-infrared spectroscopy: The fNIRS devices as an effective monitoring and therapeutic tool, evaluating the evolution of neural activity. Moreover, the cortex hemodynamic measure by fNIRS may detect early various mental disorders such as depression, fatigue, schizophrenia... through cognitive tasks.
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| | | Title | Denominators | Categories |
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| Baseline | - ParticipantsOG00046
- ParticipantsOG00146
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%. | t-test, 2 sided | | <0.05 | The threshold for statistical significance was p = 0.05. | Median Difference (Net) | 0.6 | Standard Error of the Mean | 1.3 | 2-Sided | 95 | -1.9 | 3.2 | | | Treatment Difference = Intervention group - Control group |
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| Primary | Fatigue Severity Scale (FSS) | Fatigue Severity Scale (FSS) is a 9-item self-report questionnaire. Each item is rated 1 (strongly disagree) to 7 (strongly agree). The total score is the **sum of the 9 items (range 9-63); higher scores indicate greater fatigue severity (worse outcome). The total score (9-63) was analyzed at baseline, 1, 3, and 6 months. If ≤1 item was missing, the item was imputed per instrument guidance; otherwise the score was set to missing. | Over 6 months, the numbers of patients lost to follow-up in the intervention and control groups were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 1, 3, and 6 months post intervention | | | | ID | Title | Description |
|---|
| OG000 | Multi-intervention Program | A multi-intervention program was designed for intervention groups, including:
- Periodic health check program for post-stroke: The stroke survivors will be assessed for their physical and mental health, and harmful behaviors at 0, 1, 3, and 6 months by specific scales.
- Guiding the appropriate rehabilitation exercises: The appropriate rehabilitation exercises will be designed and guided for each patient and they will be followed up by the daily online report. This arm was performed in months 1+2 (once a week), months 3+4 (every 2 weeks), and months 5 + 6 (every 4 weeks).
- Motivational Interviewing will be conducted with post-stroke patients in the first month (once a week), the second month (every 2 weeks), and the third month (every 2 weeks). Each appointment will last for 1-2 hours. This intervention method aims to discover and resolve patients' conflicts through standardized communication skills to improve their mental health and change negative behaviors.
- Functional near-infrared spectroscopy: The fNIRS devices as an effective monitoring and therapeutic tool, evaluating the evolution of neural activity. Moreover, the cortex hemodynamic measure by fNIRS may detect early various mental disorders such as depression, fatigue, and schizophrenia... through cognitive tasks.
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| Primary | Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months | Mini-Mental State Examination is a screening tool for post-stroke cognitive impairment. Scores range from 0 to 30 points, with lower scores indicating greater impairment. | Over 6 months, the numbers of patients lost to follow-up in the intervention and control groups were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months). | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 1, 3, and 6 month post intervention | | | | ID | Title | Description |
|---|
| OG000 | Multi-intervention Program | A multi-intervention program was designed for intervention groups, including:
- Periodic health check program for post-stroke: The stroke survivors will be assessed for their physical and mental health, and harmful behaviors at 0, 1, 3, and 6 months by specific scales.
- Guiding the appropriate rehabilitation exercises: The appropriate rehabilitation exercises will be designed and guided for each patient and they will be followed up by the daily online report. This arm was performed in months 1+2 (once a week), months 3+4 (every 2 weeks), and months 5 + 6 (every 4 weeks).
- Motivational Interviewing will be conducted with post-stroke patients in the first month (once a week), the second month (every 2 weeks), and the third month (every 2 weeks). Each appointment will last for 1-2 hours. This intervention method aims to discover and resolve patients' conflicts through standardized communication skills to improve their mental health and change negative behaviors.
- Functional near-infrared spectroscopy: The fNIRS devices as an effective monitoring and therapeutic tool, evaluating the evolution of neural activity. Moreover, the cortex hemodynamic measure by fNIRS may detect early various mental disorders such as depression, fatigue, and schizophrenia... through cognitive tasks.
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| Primary | Changes From Baseline Barthel Index at 1, 3, and 6 Months | Measure the changes of activities of daily living through assessing functional independence during half-year post-randomization. The score of the Barthel Index ranging from 0 to 100 was collected when 0 is the minimum (worst outcome) and 100 is the maximum (best outcome). | Over 6 months, the numbers of patients lost to follow-up in the intervention and control groups were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months) | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 1, 3, and 6 months post intervention | | | | ID | Title | Description |
|---|
| OG000 | Multi-intervention Program | A multi-intervention program was designed for intervention groups, including:
- Periodic health check program for post-stroke: The stroke survivors will be assessed for their physical and mental health, and harmful behaviors at 0, 1, 3, and 6 months by specific scales.
- Guiding the appropriate rehabilitation exercises: The appropriate rehabilitation exercises will be designed and guided for each patient and they will be followed up by the daily online report. This arm was performed in months 1+2 (once a week), months 3+4 (every 2 weeks), and months 5 + 6 (every 4 weeks).
- Motivational Interviewing will be conducted with post-stroke patients in the first month (once a week), the second month (every 2 weeks), and the third month (every 2 weeks). Each appointment will last for 1-2 hours. This intervention method aims to discover and resolve patients' conflicts through standardized communication skills to improve their mental health and change negative behaviors.
- Functional near-infrared spectroscopy: The fNIRS devices as an effective monitoring and therapeutic tool, evaluating the evolution of neural activity. Moreover, the cortex hemodynamic measure by fNIRS may detect early various mental disorders such as depression, fatigue, and schizophrenia... through cognitive tasks.
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| Primary | Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months | The Stroke Impact Scale evaluates the post-stroke quality of life, utilizing a scoring system ranging from 0 to 100, higher scores denote improved quality of life. This scale consists of 08 domains, including (1) strength; (2) memory; (3) emotion; (4) communication; (5) activities of daily living independence; (6) mobility; (7) hand function; and (8) participation. The Physical domain was calculated from the domains by averaging the values (1+5+6+7)/4. | Over 6 months, the numbers of patients lost to follow-up in the intervention and control groups were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months) | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 1, 3, and 6 months post intervention | | | | ID | Title | Description |
|---|
| OG000 | Multi-intervention Program | A multi-intervention program was designed for intervention groups, including:
- Periodic health check program for post-stroke: The stroke survivors will be assessed for their physical and mental health, and harmful behaviors at 0, 1, 3, and 6 months by specific scales.
- Guiding the appropriate rehabilitation exercises: The appropriate rehabilitation exercises will be designed and guided for each patient and they will be followed up by the daily online report. This arm was performed in months 1+2 (once a week), months 3+4 (every 2 weeks), and months 5 + 6 (every 4 weeks).
- Motivational Interviewing will be conducted with post-stroke patients in the first month (once a week), the second month (every 2 weeks), and the third month (every 2 weeks). Each appointment will last for 1-2 hours. This intervention method aims to discover and resolve patients' conflicts through standardized communication skills to improve their mental health and change negative behaviors.
- Functional near-infrared spectroscopy: The fNIRS devices as an effective monitoring and therapeutic tool, evaluating the evolution of neural activity. Moreover, the cortex hemodynamic measure by fNIRS may detect early various mental disorders such as depression, fatigue, and schizophrenia... through cognitive tasks.
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| Secondary | Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months | The Stroke Impact Scale evaluates the post-stroke quality of life, utilizing a scoring system ranging from 0 to 100, higher scores denote improved quality of life. This scale consists of 08 domains, including (1) strength; (2) memory; (3) emotion; (4) communication; (5) activities of daily living independence; (6) mobility; (7) hand function; and (8) participation | Over 6 months, the numbers of patients lost to follow-up in the intervention and control groups were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months) | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 1, 3, and 6 months post intervention | | | | ID | Title | Description |
|---|
| OG000 | Multi-intervention Program | A multi-intervention program was designed for intervention groups, including:
- Periodic health check program for post-stroke: The stroke survivors will be assessed for their physical and mental health, and harmful behaviors at 0, 1, 3, and 6 months by specific scales.
- Guiding the appropriate rehabilitation exercises: The appropriate rehabilitation exercises will be designed and guided for each patient and they will be followed up by the daily online report. This arm was performed in months 1+2 (once a week), months 3+4 (every 2 weeks), and months 5 + 6 (every 4 weeks).
- Motivational Interviewing will be conducted with post-stroke patients in the first month (once a week), the second month (every 2 weeks), and the third month (every 2 weeks). Each appointment will last for 1-2 hours. This intervention method aims to discover and resolve patients' conflicts through standardized communication skills to improve their mental health and change negative behaviors.
- Functional near-infrared spectroscopy: The fNIRS devices as an effective monitoring and therapeutic tool, evaluating the evolution of neural activity. Moreover, the cortex hemodynamic measure by fNIRS may detect early various mental disorders such as depression, fatigue, and schizophrenia... through cognitive tasks.
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