Intervention Effectiveness Towards Improving Physical and Mental Health for Post-stroke Patients.

NCT ID: NCT04941482

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2023-06-30

Brief 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. 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.

Conditions

Stroke; Brain Infarction; Brain Ischemia; Cerebral Infarction; Cerebrovascular Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Multi-intervention program

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.

Group Type: EXPERIMENTAL

Periodic health check program for post-stroke

Intervention Type: BEHAVIORAL

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 exercises

Intervention Type: BEHAVIORAL

The appropriate rehabilitation exercises were designed and guided for each patient, and they were followed up by the daily online report.

Motivational Interviewing

Intervention Type: BEHAVIORAL

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 spectroscopy

Intervention Type: DEVICE

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.

Standard care

The control group received the standard health check and was measured by an fNIRS device.

Group Type: ACTIVE_COMPARATOR

Periodic health check program for post-stroke

Intervention Type: BEHAVIORAL

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.

Functional near-infrared spectroscopy

Intervention Type: DEVICE

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.

Interventions

Periodic health check program for post-stroke

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.

Intervention Type: BEHAVIORAL

Guiding the appropriate rehabilitation exercises

The appropriate rehabilitation exercises were designed and guided for each patient, and they were followed up by the daily online report.

Intervention Type: BEHAVIORAL

Motivational Interviewing

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.

Intervention Type: BEHAVIORAL

Functional near-infrared spectroscopy

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.

Intervention Type: DEVICE

Other Intervention Names

Cognitive therapy; fNIRS

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Geriatric Hospital

OTHER_GOV

Sponsor Role: collaborator

Hanoi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thao TP Nguyen, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Hanoi Medical University, Hanoi 100000, Viet Nam

Locations

National Geriatrics Hospital

Hanoi, , Vietnam

Countries

Vietnam

References

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Reference Type: BACKGROUND

PMID: 27291521 (View on PubMed)

Cheng 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.

Reference Type: BACKGROUND

PMID: 26037617 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 22393252 (View on PubMed)

Miyai 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.

Reference Type: BACKGROUND

PMID: 14615624 (View on PubMed)

Strangman 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.

Reference Type: BACKGROUND

PMID: 17140875 (View on PubMed)

Mihara 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.

Reference Type: BACKGROUND

PMID: 27429995 (View on PubMed)

Nguyen 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.

Reference Type: DERIVED

PMID: 39610664 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

494/GCN-HDDDNCYSH-DHYHN

Identifier Type: OTHER

Identifier Source: secondary_id

9720701

Identifier Type: -

Identifier Source: org_study_id