Trial Outcomes & Findings for Intervention Effectiveness Towards Improving Physical and Mental Health for Post-stroke Patients. (NCT NCT04941482)
NCT ID: NCT04941482
Last Updated: 2025-09-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
Baseline, 1, 3, and 6 months post intervention
Results posted on
2025-09-29
Participant Flow
From December 2021 to March 2022, individuals participating in the study were selected from the statistical list of stroke patients diagnosed by a neurologist at the National Geriatric Hospital.
Of 129 individuals assessed for eligibility (screened), 92 provided informed consent and were randomized (46 per arm). 37 were excluded due to not meeting the inclusion criteria, declining to participate, or other reasons.
Participant milestones
| Measure |
Multi-intervention Program
A multi-intervention program will be designed for stroke patients, including:
1. Periodic health check program for post-stroke: The stroke survivors will be assessed their physical and mental health, and harmful behaviors at 0, 1, 3, and 6 months by specific scales.
2. 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).
3. 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.
4. 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.
|
Standard Care
Standard health check and fNIRS measure
1. Periodic health check program for post-stroke: The stroke survivors will be assessed their physical and mental health, and harmful behaviors at 0, 1, 3, and 6 months by specific scales.
2. 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.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
|
Overall Study
COMPLETED
|
37
|
43
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
Multi-intervention Program
A multi-intervention program will be designed for stroke patients, including:
1. Periodic health check program for post-stroke: The stroke survivors will be assessed their physical and mental health, and harmful behaviors at 0, 1, 3, and 6 months by specific scales.
2. 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).
3. 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.
4. 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.
|
Standard Care
Standard health check and fNIRS measure
1. Periodic health check program for post-stroke: The stroke survivors will be assessed their physical and mental health, and harmful behaviors at 0, 1, 3, and 6 months by specific scales.
2. 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.
|
|---|---|---|
|
Overall Study
At the time of confirming dropout, the dropout patients had not experienced any SAEs or fatalities.
|
9
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Multi-intervention Program
n=46 Participants
A multi-intervention program was designed for intervention groups, including:
1. 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.
2. 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).
3. 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.
4. 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.
|
Standard Care
n=46 Participants
The control group received the standard health check and fNIRS measure:
1. 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.
2. 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.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.7 years
STANDARD_DEVIATION 10.2 • n=46 Participants
|
69.8 years
STANDARD_DEVIATION 12.1 • n=46 Participants
|
72.2 years
STANDARD_DEVIATION 11.4 • n=92 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=46 Participants
|
22 Participants
n=46 Participants
|
44 Participants
n=92 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=46 Participants
|
24 Participants
n=46 Participants
|
48 Participants
n=92 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Marital status
Living with spouse
|
24 Participants
n=46 Participants
|
26 Participants
n=46 Participants
|
50 Participants
n=92 Participants
|
|
Marital status
Single, widow/widower
|
22 Participants
n=46 Participants
|
20 Participants
n=46 Participants
|
42 Participants
n=92 Participants
|
|
Employment status
Inactive
|
25 Participants
n=46 Participants
|
15 Participants
n=46 Participants
|
40 Participants
n=92 Participants
|
|
Employment status
Active
|
21 Participants
n=46 Participants
|
31 Participants
n=46 Participants
|
52 Participants
n=92 Participants
|
|
Education
Secondary school & lower
|
20 Participants
n=46 Participants
|
12 Participants
n=46 Participants
|
32 Participants
n=92 Participants
|
|
Education
High school & upper
|
26 Participants
n=46 Participants
|
34 Participants
n=46 Participants
|
60 Participants
n=92 Participants
|
|
Body mass index (BMI)
Normal (18.5-24.9)
|
28 Participants
n=46 Participants
|
29 Participants
n=46 Participants
|
57 Participants
n=92 Participants
|
|
Body mass index (BMI)
Overweight (25.0-29.9)/ Obese (≥30.0)
|
18 Participants
n=46 Participants
|
17 Participants
n=46 Participants
|
35 Participants
n=92 Participants
|
|
Blood pressure
Normal (<140 mmHg/<90 mmHg)
|
28 Participants
n=46 Participants
|
34 Participants
n=46 Participants
|
62 Participants
n=92 Participants
|
|
Blood pressure
High (≥140 mmHg and/or ≥90 mmHg)
|
18 Participants
n=46 Participants
|
12 Participants
n=46 Participants
|
30 Participants
n=92 Participants
|
|
Poor sleep quality - Pittsburgh Sleep Quality Index
No
|
8 Participants
n=46 Participants
|
16 Participants
n=46 Participants
|
24 Participants
n=92 Participants
|
|
Poor sleep quality - Pittsburgh Sleep Quality Index
Yes
|
38 Participants
n=46 Participants
|
30 Participants
n=46 Participants
|
68 Participants
n=92 Participants
|
|
Charlson Comorbidity Index (CCI)
|
5.7 units on a scale
STANDARD_DEVIATION 1.5 • n=46 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 1.4 • n=46 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 1.5 • n=92 Participants
|
|
Stroke classification
Ischemia
|
21 Participants
n=46 Participants
|
15 Participants
n=46 Participants
|
36 Participants
n=92 Participants
|
|
Stroke classification
Hemorrhage
|
5 Participants
n=46 Participants
|
7 Participants
n=46 Participants
|
12 Participants
n=92 Participants
|
|
Stroke classification
Unknown
|
20 Participants
n=46 Participants
|
24 Participants
n=46 Participants
|
44 Participants
n=92 Participants
|
|
Frequency of stroke occurrences
Once
|
34 Participants
n=46 Participants
|
31 Participants
n=46 Participants
|
65 Participants
n=92 Participants
|
|
Frequency of stroke occurrences
Twice or more
|
12 Participants
n=46 Participants
|
15 Participants
n=46 Participants
|
27 Participants
n=92 Participants
|
|
Duration from stroke onset to participate in the study
1 month to < 3 months
|
9 Participants
n=46 Participants
|
11 Participants
n=46 Participants
|
20 Participants
n=92 Participants
|
|
Duration from stroke onset to participate in the study
3 months to < 6 months
|
22 Participants
n=46 Participants
|
19 Participants
n=46 Participants
|
41 Participants
n=92 Participants
|
|
Duration from stroke onset to participate in the study
6 months to 1 year
|
15 Participants
n=46 Participants
|
16 Participants
n=46 Participants
|
31 Participants
n=92 Participants
|
|
Hemispheric lesion locations
Left-sided
|
6 Participants
n=46 Participants
|
0 Participants
n=46 Participants
|
6 Participants
n=92 Participants
|
|
Hemispheric lesion locations
Right-sided
|
17 Participants
n=46 Participants
|
24 Participants
n=46 Participants
|
41 Participants
n=92 Participants
|
|
Hemispheric lesion locations
Unknown
|
23 Participants
n=46 Participants
|
22 Participants
n=46 Participants
|
45 Participants
n=92 Participants
|
|
Disability levels of stroke survivors - MRS
No symptoms (0)
|
5 Participants
n=46 Participants
|
1 Participants
n=46 Participants
|
6 Participants
n=92 Participants
|
|
Disability levels of stroke survivors - MRS
No significant disability (1)
|
9 Participants
n=46 Participants
|
12 Participants
n=46 Participants
|
21 Participants
n=92 Participants
|
|
Disability levels of stroke survivors - MRS
Slight disability (2)
|
5 Participants
n=46 Participants
|
4 Participants
n=46 Participants
|
9 Participants
n=92 Participants
|
|
Disability levels of stroke survivors - MRS
Moderate disability (3)
|
9 Participants
n=46 Participants
|
6 Participants
n=46 Participants
|
15 Participants
n=92 Participants
|
|
Disability levels of stroke survivors - MRS
Moderate-severe disability (4)
|
18 Participants
n=46 Participants
|
23 Participants
n=46 Participants
|
41 Participants
n=92 Participants
|
|
National Institutes of Health Stroke Scale - NIHSS (score)
|
5.9 units on a scale
STANDARD_DEVIATION 4.6 • n=46 Participants
|
9.2 units on a scale
STANDARD_DEVIATION 6.4 • n=46 Participants
|
7.6 units on a scale
STANDARD_DEVIATION 5.8 • n=92 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1, 3, and 6 months post interventionPopulation: 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)
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.
Outcome measures
| Measure |
Multi-intervention Program
n=46 Participants
A multi-intervention program was designed for intervention groups, including:
1. 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.
2. 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).
3. 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.
4. 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.
|
Standard Care
n=46 Participants
The control group received the standard health check and fNIRS measure:
1. 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.
2. 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.
|
|---|---|---|
|
Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months
After 6 months
|
1.8 units on a scale
Standard Deviation 1.9
|
25.6 units on a scale
Standard Deviation 2.9
|
|
Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months
Baseline
|
10.9 units on a scale
Standard Deviation 6.5
|
10.3 units on a scale
Standard Deviation 5.9
|
|
Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months
After 1 month
|
9.1 units on a scale
Standard Deviation 1.0
|
19.7 units on a scale
Standard Deviation 3.8
|
|
Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months
After 3 months
|
3.1 units on a scale
Standard Deviation 2.8
|
24.5 units on a scale
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: Baseline, 1, 3, and 6 months post interventionPopulation: 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).
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.
Outcome measures
| Measure |
Multi-intervention Program
n=46 Participants
A multi-intervention program was designed for intervention groups, including:
1. 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.
2. 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).
3. 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.
4. 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.
|
Standard Care
n=46 Participants
The control group received the standard health check and fNIRS measure:
1. 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.
2. 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.
|
|---|---|---|
|
Fatigue Severity Scale (FSS)
Baseline
|
35.2 units on a scale
Standard Deviation 12.9
|
37.8 units on a scale
Standard Deviation 11.4
|
|
Fatigue Severity Scale (FSS)
After 1 month
|
28.5 units on a scale
Standard Deviation 11.8
|
43.4 units on a scale
Standard Deviation 8.7
|
|
Fatigue Severity Scale (FSS)
After 3 months
|
17.8 units on a scale
Standard Deviation 5.9
|
53.9 units on a scale
Standard Deviation 8.1
|
|
Fatigue Severity Scale (FSS)
After 6 months
|
14.4 units on a scale
Standard Deviation 4.9
|
57.9 units on a scale
Standard Deviation 7.6
|
PRIMARY outcome
Timeframe: Baseline, 1, 3, and 6 month post interventionPopulation: 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).
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.
Outcome measures
| Measure |
Multi-intervention Program
n=46 Participants
A multi-intervention program was designed for intervention groups, including:
1. 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.
2. 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).
3. 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.
4. 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.
|
Standard Care
n=46 Participants
The control group received the standard health check and fNIRS measure:
1. 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.
2. 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.
|
|---|---|---|
|
Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months
Baseline
|
16.2 units on a scale
Standard Deviation 7.0
|
18.3 units on a scale
Standard Deviation 8.9
|
|
Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months
After 1 month
|
13.5 units on a scale
Standard Deviation 9.7
|
18.5 units on a scale
Standard Deviation 8.7
|
|
Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months
After 3 months
|
17.9 units on a scale
Standard Deviation 10.3
|
16.2 units on a scale
Standard Deviation 7.6
|
|
Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months
After 6 months
|
19.5 units on a scale
Standard Deviation 10.6
|
15.0 units on a scale
Standard Deviation 8.3
|
PRIMARY outcome
Timeframe: Baseline, 1, 3, and 6 months post interventionPopulation: 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)
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).
Outcome measures
| Measure |
Multi-intervention Program
n=46 Participants
A multi-intervention program was designed for intervention groups, including:
1. 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.
2. 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).
3. 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.
4. 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.
|
Standard Care
n=46 Participants
The control group received the standard health check and fNIRS measure:
1. 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.
2. 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.
|
|---|---|---|
|
Changes From Baseline Barthel Index at 1, 3, and 6 Months
Baseline
|
55.5 units on a scale
Standard Deviation 36.2
|
55.4 units on a scale
Standard Deviation 34.3
|
|
Changes From Baseline Barthel Index at 1, 3, and 6 Months
After 1 month
|
58.8 units on a scale
Standard Deviation 35.2
|
55.7 units on a scale
Standard Deviation 33.9
|
|
Changes From Baseline Barthel Index at 1, 3, and 6 Months
After 3 months
|
68.8 units on a scale
Standard Deviation 28.6
|
56.2 units on a scale
Standard Deviation 33.3
|
|
Changes From Baseline Barthel Index at 1, 3, and 6 Months
After 6 months
|
68.8 units on a scale
Standard Deviation 28.6
|
54.5 units on a scale
Standard Deviation 33.0
|
PRIMARY outcome
Timeframe: Baseline, 1, 3, and 6 months post interventionPopulation: 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)
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.
Outcome measures
| Measure |
Multi-intervention Program
n=46 Participants
A multi-intervention program was designed for intervention groups, including:
1. 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.
2. 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).
3. 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.
4. 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.
|
Standard Care
n=46 Participants
The control group received the standard health check and fNIRS measure:
1. 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.
2. 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.
|
|---|---|---|
|
Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months
Baseline
|
36.9 units on a scale
Standard Deviation 24.8
|
44.4 units on a scale
Standard Deviation 29.3
|
|
Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months
After 1 month
|
28.4 units on a scale
Standard Deviation 24.3
|
37.8 units on a scale
Standard Deviation 28.0
|
|
Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months
After 3 months
|
34.7 units on a scale
Standard Deviation 26.7
|
38.2 units on a scale
Standard Deviation 27.7
|
|
Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months
After 6 months
|
38.5 units on a scale
Standard Deviation 26.8
|
32.0 units on a scale
Standard Deviation 27.3
|
SECONDARY outcome
Timeframe: Baseline, 1, 3, and 6 months post interventionPopulation: 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)
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
Outcome measures
| Measure |
Multi-intervention Program
n=46 Participants
A multi-intervention program was designed for intervention groups, including:
1. 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.
2. 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).
3. 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.
4. 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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Standard Care
n=46 Participants
The control group received the standard health check and fNIRS measure:
1. 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.
2. 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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Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months
Baseline
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45.4 units on a scale
Standard Deviation 16.4
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53.2 units on a scale
Standard Deviation 19.2
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Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months
After 1 month
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48.3 units on a scale
Standard Deviation 15.3
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44.7 units on a scale
Standard Deviation 19.6
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Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months
After 3 months
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58.5 units on a scale
Standard Deviation 15.1
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40.5 units on a scale
Standard Deviation 19.2
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Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months
After 6 months
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62.6 units on a scale
Standard Deviation 13.8
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37.0 units on a scale
Standard Deviation 18.8
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Adverse Events
Multi-intervention Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place