StrokeNCT04941482
Intervention Effectiveness Towards Improving Physical and Mental Health for Post-stroke Patients.
A study testing Periodic health check program for post-stroke, Guiding the appropriate rehabilitation exercises and Motivational Interviewing in people with Stroke and Brain Infarction, run by Hanoi Medical University at 1 site in Vietnam.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Stroke, Brain Infarction, Brain Ischemia
- What is being tested?
- Periodic health check program for post-stroke, Guiding the appropriate rehabilitation exercises and Motivational Interviewing
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stroke according to WHO's definition of stroke
- Are managed at the National Geriatrics Hospital in Vietnam
- Include 24 hours to 1 week after stroke
- Provide informed consent
- Willing to attend intervention therapies \& follow-up evaluations for half-year.
- Have conscious, cognitive, and communication abilities.
Who cannot join
- Do not agree to participate in the study
- Are included in other experimental studies
- Have mental disorders before stroke attack
- Glasgow score ≤ 8
- Other diseases that make it difficult to complete the intervention
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
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.
- Being tested
- Periodic health check program for post-stroke, Guiding the appropriate rehabilitation exercises, Motivational Interviewing, Functional near-infrared spectroscopy
- Keywords
- Stroke, Mental Health, Physical activity, Cognitive therapy, Motivational Interviewing, fNIRs, Functional near-infrared spectroscopy, Rehabilitation
- Medical subject headings
- Stroke, Brain Infarction, Brain Ischemia, Cerebral Infarction, Cerebrovascular Disorders, Psychological Well-Being, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodic health check program for post-strokeBehavioural
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.
Guiding the appropriate rehabilitation exercisesBehavioural
The appropriate rehabilitation exercises were designed and guided for each patient, and they were followed up by the daily online report.
Motivational InterviewingBehavioural
Also called Cognitive therapy
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.
Functional near-infrared spectroscopyDevice
Also called fNIRS
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.
| Study group | Role | What they receive |
|---|---|---|
| Multi-intervention program | Experimental | 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. Receives: Behavioral: Periodic health check program for post-stroke; Behavioral: Guiding the appropriate rehabilitation exercises; Behavioral: Motivational Interviewing; Device: Functional near-infrared spectroscopy |
| Standard care | Active comparator | The control group received the standard health check and was measured by an fNIRS device. Receives: Behavioral: Periodic health check program for post-stroke; Device: Functional near-infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, 1, 3, and 6 months post intervention
Secondary outcomes (1)
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
Measured: Baseline, 1, 3, and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start1 Aug 2021
- Primary completion30 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 92 stroke patients registered at the Vietnam National Geriatrics Hospital were enrolled in the study for 6 months. The patients were randomly assigned to either an intervention group that received the long-term follow-up program, or a control group that received standard care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Geriatric Hospital
- Responsible party
- Sponsor
- Investigators
- Thao TP Nguyen, MD, MSc, Principal investigator, Hanoi Medical University, Hanoi 100000, Viet Nam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941482
- Sponsor's protocol ID
- 9720701
- Other IDs
- 494/GCN-HDDDNCYSH-DHYHN
- Status last verified
- Aug 2022
- First submitted
- 10 Jun 2021
- Last updated
- 29 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feigin VL, Roth GA, Naghavi M, Parmar P, Krishnamurthi R, Chugh S, Mensah GA, Norrving B, Shiue I, Ng M, Estep K, Cercy K, Murray CJL, Forouzanfar MH; Global Burden of Diseases, Injuries and Risk Factors Study 2013 and Stroke Experts Writing Group. Global burden of stroke and risk factors in 188 countries, during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet Neurol. 2016 Aug;15(9):913-924. doi: 10.1016/S1474-4422(16)30073-4. Epub 2016 Jun 9.
PubMed 27291521Cheng D, Qu Z, Huang J, Xiao Y, Luo H, Wang J. Motivational interviewing for improving recovery after stroke. Cochrane Database Syst Rev. 2015 Jun 3;2015(6):CD011398. doi: 10.1002/14651858.CD011398.pub2.
PubMed 26037617Petersen TH, Willerslev-Olsen M, Conway BA, Nielsen JB. The motor cortex drives the muscles during walking in human subjects. J Physiol. 2012 May 15;590(10):2443-52. doi: 10.1113/jphysiol.2012.227397. Epub 2012 Mar 5.
PubMed 22393252Miyai I, Yagura H, Hatakenaka M, Oda I, Konishi I, Kubota K. Longitudinal optical imaging study for locomotor recovery after stroke. Stroke. 2003 Dec;34(12):2866-70. doi: 10.1161/01.STR.0000100166.81077.8A. Epub 2003 Nov 13.
PubMed 14615624Strangman G, Goldstein R, Rauch SL, Stein J. Near-infrared spectroscopy and imaging for investigating stroke rehabilitation: test-retest reliability and review of the literature. Arch Phys Med Rehabil. 2006 Dec;87(12 Suppl 2):S12-9. doi: 10.1016/j.apmr.2006.07.269.
PubMed 17140875Mihara M, Miyai I. Review of functional near-infrared spectroscopy in neurorehabilitation. Neurophotonics. 2016 Jul;3(3):031414. doi: 10.1117/1.NPh.3.3.031414. Epub 2016 Jul 12.
PubMed 27429995Nguyen TTP, Hoang HB, Vu HTT. Effectiveness of multifaceted interventions including motivational interviewing and home-based rehabilitation program for improving mental and physical health in stroke patients: A randomized controlled trial. Int J Nurs Stud Adv. 2024 Oct 30;7:100259. doi: 10.1016/j.ijnsa.2024.100259. eCollection 2024 Dec.
PubMed 39610664
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Effectiveness Towards Improving Physical and Mental Health for Post-stroke Patients.
- ClinicalTrials.gov ID
- NCT04941482
- Acronym / sponsor ID
- 9720701
- Keywords
- Stroke, Mental Health, Physical activity, Cognitive therapy, Motivational Interviewing, fNIRs, Functional near-infrared spectroscopy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Collaborators
- National Geriatric Hospital
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Posted 29 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 92 stroke patients registered at the Vietnam National Geriatrics Hospital were enrolled in the study for 6 months. The patients were randomly assigned to either an intervention group that received the long-term follow-up program, or a control group that received standard care.
| Arm | Type | Receives |
|---|---|---|
| Multi-intervention program | Experimental | Behavioral: Periodic health check program for post-stroke, Behavioral: Guiding the appropriate rehabilitation exercises, Behavioral: Motivational Interviewing, Device: Functional near-infrared spectroscopyA 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. |
| Standard care | Active comparator | Behavioral: Periodic health check program for post-stroke, Device: Functional near-infrared spectroscopyThe control group received the standard health check and was measured by an fNIRS device. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of stroke according to WHO's definition of stroke
- Are managed at the National Geriatrics Hospital in Vietnam
- Include 24 hours to 1 week after stroke
- Provide informed consent
- Willing to attend intervention therapies \& follow-up evaluations for half-year.
Key exclusion criteria (5 listed)
- Do not agree to participate in the study
- Are included in other experimental studies
- Have mental disorders before stroke attack
- Glasgow score ≤ 8
- Other diseases that make it difficult to complete the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodic health check program for post-strokeThe 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. | Behavioural | Multi-intervention program, Standard care |
| Guiding the appropriate rehabilitation exercisesThe appropriate rehabilitation exercises were designed and guided for each patient, and they were followed up by the daily online report. | Behavioural | Multi-intervention program |
| Motivational InterviewingAlso: Cognitive therapyMotivational 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. | Behavioural | Multi-intervention program |
| Functional near-infrared spectroscopyAlso: fNIRSThe 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. | Device | Multi-intervention program, Standard care |
Primary outcome
Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months
Time frame: Baseline, 1, 3, and 6 months post intervention
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.
Fatigue Severity Scale (FSS)
Time frame: Baseline, 1, 3, and 6 months post intervention
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.
Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months
Time frame: Baseline, 1, 3, and 6 month post intervention
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.
Changes From Baseline Barthel Index at 1, 3, and 6 Months
Time frame: Baseline, 1, 3, and 6 months post intervention
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).
Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months
Time frame: Baseline, 1, 3, and 6 months post intervention
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.
1 secondary outcome
Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months
Time frame: Baseline, 1, 3, and 6 months post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27291521Feigin VL, Roth GA, Naghavi M, Parmar P, Krishnamurthi R, Chugh S, Mensah GA, Norrving B, Shiue I, Ng M, Estep K, Cercy K, Murray CJL, Forouzanfar MH; Global Burden of Diseases, Injuries and Risk Factors Study 2013 and Stroke Experts Writing Group. Global burden of stroke and risk factors in 188 countries, during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet Neurol. 2016 Aug;15(9):913-924. doi: 10.1016/S1474-4422(16)30073-4. Epub 2016 Jun 9.
- Background: PubMed 26037617Cheng D, Qu Z, Huang J, Xiao Y, Luo H, Wang J. Motivational interviewing for improving recovery after stroke. Cochrane Database Syst Rev. 2015 Jun 3;2015(6):CD011398. doi: 10.1002/14651858.CD011398.pub2.
- Background: PubMed 22393252Petersen TH, Willerslev-Olsen M, Conway BA, Nielsen JB. The motor cortex drives the muscles during walking in human subjects. J Physiol. 2012 May 15;590(10):2443-52. doi: 10.1113/jphysiol.2012.227397. Epub 2012 Mar 5.
- Background: PubMed 14615624Miyai I, Yagura H, Hatakenaka M, Oda I, Konishi I, Kubota K. Longitudinal optical imaging study for locomotor recovery after stroke. Stroke. 2003 Dec;34(12):2866-70. doi: 10.1161/01.STR.0000100166.81077.8A. Epub 2003 Nov 13.
- Background: PubMed 17140875Strangman G, Goldstein R, Rauch SL, Stein J. Near-infrared spectroscopy and imaging for investigating stroke rehabilitation: test-retest reliability and review of the literature. Arch Phys Med Rehabil. 2006 Dec;87(12 Suppl 2):S12-9. doi: 10.1016/j.apmr.2006.07.269.
- Background: PubMed 27429995Mihara M, Miyai I. Review of functional near-infrared spectroscopy in neurorehabilitation. Neurophotonics. 2016 Jul;3(3):031414. doi: 10.1117/1.NPh.3.3.031414. Epub 2016 Jul 12.
- Derived from this study: PubMed 39610664Nguyen TTP, Hoang HB, Vu HTT. Effectiveness of multifaceted interventions including motivational interviewing and home-based rehabilitation program for improving mental and physical health in stroke patients: A randomized controlled trial. Int J Nurs Stud Adv. 2024 Oct 30;7:100259. doi: 10.1016/j.ijnsa.2024.100259. eCollection 2024 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thao TP Nguyen, MD, MSc principal investigator
Hanoi Medical University, Hanoi 100000, Viet Nam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodic health check program for post-stroke, Guiding the appropriate rehabilitation exercises and Motivational Interviewing in people with Stroke and Brain Infarction, run by Hanoi Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months (time frame: Baseline, 1, 3, and 6 months post intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04941482, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.