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

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).

Study Overview

• Status: Completed
• Conditions: Stroke; Cerebrovascular Disorders; Brain Ischemia; Cerebral Infarction; Brain Infarction
• Intervention / Treatment: Behavioral: Motivational Interviewing; Behavioral: Periodic health check program for post-stroke; Behavioral: Guiding the appropriate rehabilitation exercises; Device: Functional near-infrared spectroscopy

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam, 100000
    • National Geriatrics Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Cognitive therapy; Behavioral: 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.; 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.; Device: 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.; Other Names: fNIRS
Active Comparator: Standard care; The control group received the standard health check and was measured by an fNIRS device.	Behavioral: 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.; Device: 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.; Other Names: fNIRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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.	Baseline, 1, 3, and 6 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 1, 3, and 6 months post intervention

Collaborators and Investigators

• Sponsor: Hanoi Medical University
• Collaborators: National Geriatric Hospital
• Investigators: Principal Investigator: Thao TP Nguyen, MD, MSc, Hanoi Medical University, Hanoi 100000, Viet Nam

Publications and helpful links

General 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.
• 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.
• Petersen 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Mental Health; Stroke; Motivational Interviewing; Physical activity; Cognitive therapy; Functional near-infrared spectroscopy; fNIRs
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Infarction; Necrosis; Ischemia; Pathological Conditions, Signs and Symptoms; Behavior; Personal Satisfaction; Stroke; Cerebral Infarction; Cerebrovascular Disorders; Brain Ischemia; Brain Infarction; Psychological Well-Being; Motor Activity; Health Services; Health Care Facilities Workforce and Services; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Cognitive Behavioral Therapy; Motivational Interviewing
• Other Study ID Numbers: 9720701; 494/GCN-HDDDNCYSH-DHYHN (Other Identifier: Hanoi Medical University Institutional Ethical Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No