An interventional study of Periodic health check program for post-stroke and Guiding the appropriate rehabilitation exercises in Stroke, Brain Infarction and Brain Ischemia, sponsored by Hanoi Medical University. Completed at 1 site in Vietnam. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by Hanoi Medical University · Not applicable, Interventional, and Prevention
This was a multi-intervention randomized controlled trial that aimed to develop a management pattern for stroke survivors. The program consisted of monitoring the recovery process, early detecting the physical and mental disorders, suitably intervening for each patient to improve their quality of life. New intervention techniques were firstly applied for post-stroke patients in Vietnam such as using the portable functional near-infrared spectroscopy (fNIRS) device to explore cortex frontal hemodynamic and motivational interviewing for psychological adjustment. A total of 92 stroke patients registered in Vietnam National Geriatrics Hospital were included in the study for 6 months. Included patients were randomized to an intervention group and received the long-term follow-up program or to a control group receiving standard care. The mental health and physical functioning of participants were assessed at 0, 1, 3, and 6 months follow-up. This work was funded by Vingroup Joint Stock Company and supported by the Domestic Master/Ph.D. Scholarship Programme of Vingroup Innovation Foundation (VINIF), Vingroup Big Data Institute (VINBIGDATA).
Stroke is a medical condition that occurs when a blood vessel that carries oxygen and nutrients to the brain is either blocked by a clot or bursts (or ruptures). This is a major cause of death and disability worldwide. Post-stroke patients will experience sudden and intense changes in their physical and mental health during the first year. Currently, there is no official management model for improving the physical and mental health of patients after stroke in Vietnam. Furthermore, traditional neuroimaging techniques such as Functional magnetic resonance imaging (fMRI), Positron emission tomography (PET), Electroencephalogram (EEG) are not suitable for routine monitoring due to limited flexibility dynamics and costs. Hence, this study aimed to develop a management pattern that included monitoring the recovery process, early detecting the physical and mental disorders, suitably intervening for each patient to improve their quality of life. New intervention techniques were firstly applied for post-stroke patients in Vietnam such as using the portable fNIRS device to explore cortex frontal hemodynamic and motivational interviewing for psychological adjustment. This randomized controlled trial study included 92 post-stroke patients with dividing into two groups (46 control \& 46 intervention subjects), who experienced emergency by stroke within one week. A multi-intervention program was designed for stroke patients including [1] periodic health examination for assessment of physical and mental health, recurrence risks, and harmful behaviors; [2] guiding the appropriate rehabilitation exercises for improving the physical status and monitoring through daily online reports; [3] using motivational interviewing methods to improve and prevent mental disorder; [4] application of the technique of functional near-infrared spectroscopy (fNIRS) for measurement of oxy-hemoglobin on cortex prefrontal to early detect mental disorder and stroke recurrence risks. Outcome data were collected via study questionnaires and fNIRS measuring results which were administered by researchers in the study site at 0, 1, 3, and 6 months follow-up. Simultaneously, Motivational Interviewing was carried out on post-stroke patients in the first three months (one time per week in the first month and one time per second and third month). This intervention method aimed to discover and resolve patient's conflicts by standardized communication skill to improve their mental health and change negative behaviors. The scores of the Stroke Impact Scale (SIS), physical and mental assessment scales and fNIRS data in both groups were used to calculate the effect estimates of intervention methods with a measure of precision (95% CI) and assess the results of the trial.
219 studies on the registry are indexed under Cerebral Infarction; 46 are open to participants now.
This study's enrollment of 92 is below the median of 120 across 139 interventional studies indexed under Cerebral Infarction.
Browse Cerebral Infarction studies →Hanoi Medical University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.
Compared within Cerebral Infarction, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A multi-intervention program was designed for stroke patients, including: \[1\] periodic health examinations for assessing physical and mental health, recurrence risks, and harmful behaviors; \[2\] guiding appropriate rehabilitation exercises to improve physical status and monitoring through daily online reports; \[3\] using motivational interviewing methods to improve and prevent mental disorders; \[4\] using the technique of functional near-infrared spectroscopy (fNIRS) to measure oxy-hemoglobin in the prefrontal cortex to early detect mental disorders and stroke recurrence risks.
Behavioral: Periodic health check program for post-stroke · Behavioral: Guiding the appropriate rehabilitation exercises · Behavioral: Motivational Interviewing · Device: Functional near-infrared spectroscopy
The control group received the standard health check and was measured by an fNIRS device.
Behavioral: Periodic health check program for post-stroke · Device: Functional near-infrared spectroscopy
The stroke survivors were assessed for their physical and mental health, recurrence risks, and harmful behaviors at 0, 1, 3, and 6 months using specific scales.
The appropriate rehabilitation exercises were designed and guided for each patient, and they were followed up by the daily online report.
Motivational Interviewing will carry out on post-stroke patients in the first three months (one time per week in the first month and one time per the second and third month). This intervention method aims to discover and resolve patient's conflicts by a standardized communication skill to improve their mental health and change negative behaviors.
Also known as: Cognitive therapy
The fNIRS devices served as an effective monitoring and therapeutic tool, evaluating the evolution of neural activity and stroke rehabilitation and recovery. Moreover, the cortex hemodynamic measurement by fNIRS could detect various mental disorders such as depression, anxiety, schizophrenia early through cognitive tasks.
Also known as: fNIRS
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.
Time frame: Baseline, 1, 3, and 6 months post intervention
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.
Time frame: Baseline, 1, 3, and 6 months post intervention
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.
Time frame: Baseline, 1, 3, and 6 month post intervention
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).
Time frame: Baseline, 1, 3, and 6 months post intervention
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.
Time frame: Baseline, 1, 3, and 6 months post intervention
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
Time frame: Baseline, 1, 3, and 6 months post intervention
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.
| Milestone | Multi-intervention Program | Standard Care |
|---|---|---|
| Started | 46 | 46 |
| Completed | 37 | 43 |
| Not completed | 9 | 3 |
| Withdrew: At the time of confirming dropout, the dropout patients had not experienced any saes or fatalities. | 9 | 3 |
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.
| units on a scale | Multi-intervention Program | Standard Care |
|---|---|---|
| Baseline | 10.9 ± 6.5 | 10.3 ± 5.9 |
| After 1 month | 9.1 ± 1.0 | 19.7 ± 3.8 |
| After 3 months | 3.1 ± 2.8 | 24.5 ± 2.8 |
| After 6 months | 1.8 ± 1.9 | 25.6 ± 2.9 |
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.
| units on a scale | Multi-intervention Program | Standard Care |
|---|---|---|
| Baseline | 35.2 ± 12.9 | 37.8 ± 11.4 |
| After 1 month | 28.5 ± 11.8 | 43.4 ± 8.7 |
| After 3 months | 17.8 ± 5.9 | 53.9 ± 8.1 |
| After 6 months | 14.4 ± 4.9 | 57.9 ± 7.6 |
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.
| units on a scale | Multi-intervention Program | Standard Care |
|---|---|---|
| Baseline | 16.2 ± 7.0 | 18.3 ± 8.9 |
| After 1 month | 13.5 ± 9.7 | 18.5 ± 8.7 |
| After 3 months | 17.9 ± 10.3 | 16.2 ± 7.6 |
| After 6 months | 19.5 ± 10.6 | 15.0 ± 8.3 |
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).
| units on a scale | Multi-intervention Program | Standard Care |
|---|---|---|
| Baseline | 55.5 ± 36.2 | 55.4 ± 34.3 |
| After 1 month | 58.8 ± 35.2 | 55.7 ± 33.9 |
| After 3 months | 68.8 ± 28.6 | 56.2 ± 33.3 |
| After 6 months | 68.8 ± 28.6 | 54.5 ± 33.0 |
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.
| units on a scale | Multi-intervention Program | Standard Care |
|---|---|---|
| Baseline | 36.9 ± 24.8 | 44.4 ± 29.3 |
| After 1 month | 28.4 ± 24.3 | 37.8 ± 28.0 |
| After 3 months | 34.7 ± 26.7 | 38.2 ± 27.7 |
| After 6 months | 38.5 ± 26.8 | 32.0 ± 27.3 |
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
| units on a scale | Multi-intervention Program | Standard Care |
|---|---|---|
| Baseline | 45.4 ± 16.4 | 53.2 ± 19.2 |
| After 1 month | 48.3 ± 15.3 | 44.7 ± 19.6 |
| After 3 months | 58.5 ± 15.1 | 40.5 ± 19.2 |
| After 6 months | 62.6 ± 13.8 | 37.0 ± 18.8 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Multi-intervention Program | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Standard Care | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Age, Continuous(years) | Multi-intervention Program | Standard Care | Total |
|---|---|---|---|
| Mean | 74.7 ± 10.2 | 69.8 ± 12.1 | 72.2 ± 11.4 |
| Sex: Female, Male(Participants) | Multi-intervention Program | Standard Care | Total |
|---|---|---|---|
| Female | 22 | 22 | 44 |
| Male | 24 | 24 | 48 |
| Race and Ethnicity Not Collected(Participants) | Multi-intervention Program | Standard Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Marital status(Participants) | Multi-intervention Program | Standard Care | Total |
|---|---|---|---|
| Living with spouse | 24 | 26 | 50 |
| Single, widow/widower | 22 | 20 | 42 |
| Employment status(Participants) | Multi-intervention Program | Standard Care | Total |
|---|---|---|---|
| Inactive | 25 | 15 | 40 |
| Active | 21 | 31 | 52 |
| Education(Participants) | Multi-intervention Program | Standard Care | Total |
|---|---|---|---|
| Secondary school & lower | 20 | 12 | 32 |
| High school & upper | 26 | 34 | 60 |
| Body mass index (BMI)(Participants) | Multi-intervention Program | Standard Care | Total |
|---|---|---|---|
| Normal (18.5-24.9) | 28 | 29 | 57 |
| Overweight (25.0-29.9)/ Obese (≥30.0) | 18 | 17 | 35 |
| Blood pressure(Participants) | Multi-intervention Program | Standard Care | Total |
|---|---|---|---|
| Normal (<140 mmHg/<90 mmHg) | 28 | 34 | 62 |
| High (≥140 mmHg and/or ≥90 mmHg) | 18 | 12 | 30 |
8 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2021 to primary completion in Dec 2022, 16 months.
Results were first posted in Sep 2025, 2 years 8 months after primary completion.
Of 27 interventional studies with no phase under Cerebral Infarction, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 49. This study's 16 months is below that.
How these figures are worked out, and which studies are left out of them.
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Hanoi Medical University