Intervention Effectiveness Towards Improving Physical and Mental Health for Post-stroke Patients.
Phase: NA
Conditions: Stroke, Brain Infarction, Brain Ischemia, Cerebral Infarction, Cerebrovascular Disorders
Sponsor: Hanoi Medical University

STUDY PROTOCOL 
Official Title: Intervention Effectiveness Towards Improving Physical and Mental Health for 
Post-stroke Patients. 
ClinicalTrials.gov Identifier: NCT04941482. 
Document Type: Study Protocol. 
Version: 2.0 – 25 December 2021. 
Principal Investigator: Nguyen Thi Phuong Thao, MD, MSc 
Affiliation: Institute for Preventive Medicine and Public Health, Hanoi Medical University, 
Vietnam. 
Background and Rationale 
Stroke is a leading cause of long-term disability and the second leading cause of death 
worldwide [1]. Many stroke survivors suffer from post-stroke depression (PSD), fatigue, 
cognitive impairments, and reduced functional abilities, which significantly hinder 
rehabilitation outcomes and quality of life [2-5]. Early detection and intervention for these 
physical and mental health issues are crucial for optimal recovery. However, most studies to 
date have addressed either physical rehabilitation or psychological therapy alone, rather than 
an integrated approach targeting both aspects [6, 7]. In Vietnam, there has been a lack of 
comprehensive intervention studies for post-stroke patients, and access to specialized inpatient 
rehabilitation is limited. This gap has led to increased demand for home-based rehabilitation 
and innovative strategies to support stroke survivors’ mental health in the community. 
Motivational Interviewing (MI) is a client-centered counseling technique effective in 
enhancing motivation and treating depression and fatigue in various conditions [8, 9]. Home-
based rehabilitation programs, especially with family involvement and guided exercises, have 
been shown to improve functional independence and accelerate recovery in stroke patients [10]. 
We hypothesize that combining MI therapy with a structured home-based exercise program (a 
multifaceted intervention) will yield synergistic benefits, improving both mental health (e.g., 
reducing depression and fatigue) and physical function beyond what standard care achieves. 
In addition, traditional neuroimaging methods to monitor mental health recovery (e.g. fMRI, 
PET, EEG) are often impractical in routine care due to cost and limited portability [11-13]. 
Functional Near-Infrared Spectroscopy (fNIRS) offers a noninvasive, portable, and low-cost 
brain monitoring tool that can track changes in cerebral blood oxygenation with high temporal 
resolution [14]. fNIRS has been used successfully to evaluate depression and other mental 
health conditions by detecting hemodynamic changes in the prefrontal cortex [15, 16]. 
Applying fNIRS in post-stroke patients could provide an objective biomarker of improvement 
in depression and cognitive function in response to our intervention [15]. This study is 
pioneering in Vietnam as it combines physical rehabilitation, MI, and fNIRS-based monitoring 
to address post-stroke health comprehensively. The knowledge gained may guide future stroke 
care programs and health policy in resource-limited settings. 
Trial Objectives and Hypotheses 
Primary Objective: To evaluate the effectiveness of a 6-month multifaceted intervention 
(Motivational Interviewing plus a home-based rehabilitation program) in improving the mental 
health (reducing depressive symptoms, fatigue, and cognitive impairment) and physical 

functional status of post-stroke patients, compared to standard care alone. The primary 
endpoints include changes in depression severity, fatigue level, cognitive function, and 
activities of daily living from baseline to 6 months. 
Secondary Objectives: (1) To assess the impact of the intervention on post-stroke quality of 
life. (2) To explore neurobiological changes associated with depression improvement by 
measuring prefrontal cortex oxyhemoglobin concentration changes using fNIRS, and 
determine whether fNIRS biomarkers can serve as predictors of depression status in stroke 
survivors. 
Hypotheses: We hypothesize that stroke survivors receiving the combined MI and home-based 
rehabilitation intervention will show significantly greater improvements in mental health 
outcomes (lower Patient Health Questionnaire-9 depression scores and Fatigue Severity Scale 
scores, improved Mini-Mental State Examination scores) and physical function (higher Barthel 
Index scores) over 6 months, compared to those receiving standard care. We also hypothesize 
that the intervention group will exhibit measurable increases in prefrontal cortical activation 
(oxyhemoglobin levels) on fNIRS correlating with reduction in depressive symptoms, and that 
specific fNIRS-derived metrics will predict depression remission status with reasonable 
accuracy. 
Study Design 
This study is a single-center, parallel-group randomized controlled trial with a 1:1 allocation 
ratio to intervention versus control. The trial was conducted at the Vietnam National Geriatric 
Hospital from 2021 to 2022. A total of 92 stroke survivor participants were enrolled and 
randomly assigned to either the Intervention group, which received a multi-component 
program (Motivational Interviewing plus a home-based rehabilitation regimen), or the Control 
group, which received standard care and general health advice. The study duration for each 
participant is approximately 6 months, with assessments at baseline and follow-up at 1, 3, and 
6 months post-enrollment. Figure 1 presents the planned participant flow per CONSORT 
guidelines (see Schedule of Events below for timeline of activities). The trial is open-label: due 
to the nature of the interventions, neither participants nor intervention providers were blinded 
to group assignment. To reduce potential bias, outcome assessments were standardized, and 
the data analyst/statistician remained blinded to group labels during analysis. 
Eligibility Criteria 
Inclusion Criteria: Adults aged ≥45 years who have a confirmed clinical diagnosis of stroke 
(ischemic or hemorrhagic) according to WHO criteria [17]. Eligible patients must be 1 to 12 
months post-stroke (stroke onset between 1 month and 1 year before enrollment), and be 
medically stable enough to participate in outpatient rehabilitation activities. Participants should 
have sufficient cognitive capacity and communication ability to engage in interviews and 
therapy sessions, and be willing to provide informed consent. They must be capable of taking 
part in the intervention protocols, including attending counseling sessions and performing 
exercises (with assistance from caregivers if needed). 
Exclusion Criteria: Patients with a history of serious mental illness prior to stroke (e.g. major 
depressive disorder, anxiety disorder, schizophrenia, or other psychiatric illnesses diagnosed 
before the stroke) are excluded to avoid confounding pre-existing conditions. We also exclude 
those with other significant neurological disorders unrelated to stroke (e.g. Parkinson’s disease, 
dementia) or those who experienced only transient ischemic attacks. Patients with unstable 
medical conditions that would interfere with participation (such as severe consciousness 

disorders, uncontrolled comorbid illness, or inability to communicate) are excluded. Finally, 
patients who are unable to provide informed consent (for example, due to severe cognitive 
impairment with no available legally acceptable representative) are not enrolled. 
Description of Interventions 
Intervention Group: Motivational Interviewing + Home-Based Rehabilitation 
Participants randomized to the intervention group receive Motivational Interviewing (MI) 
therapy in conjunction with a structured home-based rehabilitation exercise program, in 
addition to standard post-stroke care. 
• Motivational Interviewing (MI): MI is delivered through one-on-one counseling 
sessions aimed at enhancing the patient’s motivation and psychological adjustment 
post-stroke. The sessions are facilitated by trained nurses and social workers who 
completed a formal MI training program (including an MI in Healthcare course and 
practice sessions supervised by certified MI trainers). Ongoing supervision and fidelity 
checks were in place: sessions were audio-recorded (with consent) and reviewed by MI 
experts to ensure adherence to MI principles, such as expressing empathy, supporting 
patient autonomy, and eliciting “change talk”. Facilitators failing to meet competence 
standards received additional training. Each participant in the intervention arm receives 
a total of eight MI sessions over three months. Sessions are front-loaded weekly in the 
first month (approximately 4 sessions in Month 1), then held biweekly during Months 
2 and 3. Each session lasts ~1 hour and is conducted face-to-face in a private room at 
the hospital to maintain confidentiality and focus. The MI intervention content is 
tailored to post-stroke adjustment, covering: (1) building rapport and discussing the 
challenges of life after stroke; (2) helping the patient identify personal recovery goals 
and barriers; and (3) resolving ambivalence and reinforcing optimism and self-efficacy 
for achieving those goals. Participants are encouraged to summarize their goals and 
commitments, especially by the end of the early sessions, to reinforce their motivation 
moving forwar. MI facilitators do not overlap with outcome assessors and are not 
involved in patient recruitment, to minimize bias. 
• Home-Based Rehabilitation Program: In addition to MI, intervention group patients 
engage in a personalized home exercise program guided by rehabilitation therapists. A 
physical therapist provides an initial assessment of each patient’s functional abilities 
and limitations (covering mobility, basic activities of daily living, etc.) and, together 
with a multidisciplinary team (including occupational and speech therapists as needed), 
develops an individualized exercise plan. Therapy guidance is delivered through 
scheduled home visits and coaching sessions over the 6-month intervention period. 
Specifically, a therapist conducts home visits once a week during months 1–2, every 2 
weeks during months 3–4, and once every 4 weeks during months 5–6. This tapering 
schedule provides more intensive support early on and encourages growing 
independence later. In total, participants receive approximately 12 home visit sessions 
(weekly for 8 weeks, biweekly for 8 weeks, monthly for 8 weeks). During each visit 
(~1 hour), the therapist trains the patient (and caregiver) in exercises and activities 
aimed at improving strength, balance, mobility, and self-care skills. Standard 
rehabilitation techniques are employed (passive/active range-of-motion exercises, 
strength training, task-oriented practice for daily activities, etc.), often using an 
audiovisual instructional DVD to standardize exercise routines. Example activities 
include gait training with a cane or wheelchair, practicing transfers and stair climbing, 
and fine motor tasks like using a key or preparing a drink. Caregivers are instructed on 

how to assist and encourage the patient’s independent function as much as possible. 
Patients keep a daily exercise log or diary to record their at-home practice outside of 
the supervised visits. The therapist’s contact information is provided so 
patients/caregivers can consult with questions between visits. Any issues encountered 
at home are addressed through counseling or adaptation of the exercises (including 
additional education for caregivers on managing common problems). This home-based 
rehabilitation component is designed to complement the MI sessions by improving 
physical capabilities and thereby enabling patients to pursue the goals they set during 
MI. 
• Periodic Health Checks: Throughout the study, intervention group participants also 
receive routine medical monitoring and standard stroke care. Doctors at the hospital’s 
outpatient clinic see the patients at baseline, 1, 3, and 6 months for general health 
evaluations, management of comorbid conditions (e.g. hypertension, diabetes), and 
reinforcement of healthy behaviors. This ensures any new medical issues are addressed 
promptly and that participants receive equivalent medical attention as the control group. 
Control Group: Standard Care 
Participants in the control arm receive standard post-stroke care and follow-up as per usual 
practice, without the specialized MI or home-visit exercise program. All control group patients 
undergo the same schedule of periodic health check-ups at baseline, 1, 3, and 6 months with 
their physicians at the National Geriatric Hospital. During these visits, any medical or 
rehabilitation needs are managed according to routine care protocols. If a control patient is 
identified (during assessments or clinic visits) to have significant depression or other mental 
health issues, they are referred for appropriate evaluation or treatment by a psychiatrist as 
needed. Control participants and their families are provided with general written educational 
materials on post-stroke care and rehabilitation (e.g. standard pamphlets from the Ministry of 
Health). They are encouraged to continue any home exercises advised during their hospital 
discharge, but no structured, therapist-guided home exercise sessions or motivational 
counseling sessions are provided to the control group during the study period. Any additional 
treatments or services the control participants receive outside the study (e.g. if they seek 
physiotherapy on their own) are documented in case report forms for transparency. By 
comparing this group to the intervention group, we can isolate the effect of the motivational 
interviewing and guided home rehab program over and above usual care. 
Outcome Measures 
All participants are assessed at four time points: baseline (pre-intervention), 1 month, 3 months, 
and 6 months post-enrollment. Evaluations are conducted by a trained research nurse or 
clinician (who was not involved in delivering the intervention) using standardized instruments. 
The primary outcomes are divided into mental health outcomes and physical health outcomes, 
reflecting the dual focus of the intervention: 
• Depressive Symptoms: Measured by the Patient Health Questionnaire-9 (PHQ-9), a 
validated 9-item self-report scale for screening and severity of depression [18]. Each 
PHQ-9 item is scored from 0 (“not at all”) to 3 (“nearly every day”), yielding a total 
score from 0 to 27, with higher scores indicating more severe depression. The PHQ-9 
has been validated in Vietnamese stroke populations for detecting PSD [19]. A decrease 
in PHQ-9 score over time signifies improvement in depressive symptoms. 

• Fatigue: Measured by the Fatigue Severity Scale (FSS), a questionnaire assessing the 
impact of fatigue on daily functioning [20]. Participants rate 9 statements about fatigue 
(e.g. impact on physical functioning, motivation) on a 7-point scale (1 = strongly 
disagree to 7 = strongly agree). The scores are summed to give a total from 9 to 63 
(occasionally a 10th item is included, in which case the range is 10–70). Higher FSS 
scores mean greater fatigue severity. In this study, FSS is treated as a continuous 
outcome; a reduction in score indicates fatigue improvement. Notably, the FSS 
demonstrated excellent internal consistency in our sample (Cronbach’s α ~0.97–0.99 
across time points) [20]. 
• Cognitive Function: Assessed by the Mini-Mental State Examination (MMSE), an 
11-item test of global cognitive status [21]. The MMSE evaluates domains such as 
orientation, immediate and short-term memory, attention/calculation, language, and 
visuoconstructional skills. Scores range from 0 to 30, with scores ≤24 commonly 
indicating cognitive impairment in stroke survivors [21]. The MMSE has been 
validated for use in Vietnam [22]. An increase in MMSE score from baseline indicates 
cognitive improvement. 
• Physical Function (Activities of Daily Living): Measured by the Barthel Index (BI) 
for activities of daily living. The BI rates a person’s independence in 10 daily tasks 
(feeding, bathing, grooming, dressing, bowel/bladder control, toilet use, chair transfer, 
ambulation, and stair climbing). Total scores range from 0 (completely dependent) to 
100 (fully independent). The Barthel Index is well-established and has been culturally 
adapted in Vietnam [23]. Improvement in BI score reflects gains in the ability to 
perform daily activities without assistance. 
These four measures (PHQ-9, FSS, MMSE, and Barthel Index) are considered the primary 
outcomes, representing mental and physical health domains targeted by the intervention. In 
addition, we track a secondary outcome of overall post-stroke recovery: 
• Quality of Life: Evaluated using the Stroke Impact Scale 3.0 (SIS-16), a stroke-
specific quality-of-life questionnaire [24]. The SIS assesses 8 domains including 
strength, hand function, mobility, ADL/IADL, memory, communication, emotion, and 
social participation. Domain scores and an overall composite can be calculated on a 0–
100 scale, with higher scores indicating better functioning and quality of life [24]. We 
will primarily use the total SIS score as an outcome of global recovery. (This measure 
is secondary/exploratory; not all participants may complete the full SIS due to time 
constraints.) 
• Neuroimaging Biomarkers (Exploratory): Changes in cerebral oxyhemoglobin 
concentration in the prefrontal cortex, as measured by fNIRS, serve as an exploratory 
biomarker of depression and cognitive improvement. A portable 48-channel fNIRS 
device (NIRSIT, OBELAB, South Korea) is used to record cortical hemodynamic 
responses while participants perform a brief cognitive task (e.g. verbal fluency task) at 
baseline, 3 months, and 6 months (fNIRS is not administered at the 1-month visit). The 
fNIRS optode array is positioned over the forehead (frontopolar and lateral prefrontal 
regions) to capture activity in brain areas implicated in mood regulation (such as the 
orbitofrontal cortex). Oxyhemoglobin (HbO₂) and deoxyhemoglobin signals are 
calculated using the modified Beer–Lambert law and are sampled at high temporal 
resolution during the cognitive challenge [25]. For analysis, we will examine the mean 
change in HbO₂ from baseline during task performance for specific regions of interest 

(e.g. left orbitofrontal cortex, ventrolateral PFC) and how these values change from pre- 
to post-intervention. Prior studies suggest that greater increases in prefrontal HbO₂ 
activation correspond to better emotional and cognitive outcomes [26]. We will explore 
whether our intervention group shows increased HbO₂ responses over time relative to 
controls, and whether certain threshold values of HbO₂ change can distinguish 
participants with resolved depression from those with persistent depression by 6 
months. These fNIRS measurements are considered an exploratory outcome and will 
not be used as primary endpoints, but rather to supplement and biologically 
contextualize the clinical findings. 
All outcome instruments (questionnaires and cognitive tests) are administered in the 
Vietnamese language by research staff. Standardized, validated Vietnamese versions are used 
for all scales (e.g. the PHQ-9 and MMSE have validated translations). For quality control, the 
same instruments are used at each follow-up, and staff members were trained to maintain 
consistency in administration. 
Schedule of Events (Study Timeline) 
The schedule of enrollment, interventions, and assessments is based on SPIRIT guidelines and 
is summarized below: 
• Screening & Baseline (Month 0): Potential participants are screened against 
inclusion/exclusion criteria and provide written informed consent. At enrollment (pre-
intervention baseline), we collect demographic information and stroke history 
(including stroke type, time since onset, lesion location, disability status by Modified 
Rankin Scale, etc.). Baseline assessments include the PHQ-9, FSS, MMSE, Barthel 
Index, and SIS administered via interview, as well as the first fNIRS measurement 
during a cognitive task. After baseline assessments, participants are randomized to 
either the intervention or control group. For those in the intervention arm, the first MI 
session typically occurs immediately or within a week after randomization, and the 
home-based rehab program is initiated with a visit scheduling within the first week. 
• Intervention Period (Month 0 to Month 6): The intervention group undergoes the 
structured program as described: MI sessions weekly in Month 1 and biweekly in 
Months 2–3 (8 sessions total), and physical therapist home visits weekly in Months 1–
2, biweekly in Months 3–4, and monthly in Months 5–6. All intervention activities are 
logged. The control group receives no intervention during this period beyond usual 
care, though both groups continue to attend routine medical appointments as scheduled. 
• 1-Month Follow-up (Month 1): Both groups return for a follow-up visit at ~1 month 
post-baseline. Outcome assessments at this visit include PHQ-9, FSS, MMSE, Barthel 
Index, and SIS. These are administered by the study assessor to track early changes. 
(No fNIRS measurement is performed at 1 month in this study design.) The intervention 
group will have completed roughly four MI sessions by this point (if on schedule) and 
continues with weekly rehab visits through Month 2. The control group’s visit consists 
of their routine check-up and outcome questionnaires. 
• 3-Month Follow-up (Month 3): A mid-point evaluation is conducted at 3 months for 
all participants. Outcome measures (PHQ-9, FSS, MMSE, Barthel, SIS) are 
administered again, and the second fNIRS assessment is performed for both groups 
under the same protocol as baseline. By Month 3, participants in the intervention arm 
will have completed the course of eight MI sessions (the final MI sessions occur around 

week 10–12). They will also have had biweekly rehab visits through Month 3. The 3-
month follow-up allows assessment of mid-intervention improvements and provides 
data for any necessary intervention adjustments. Control group participants continue to 
receive standard care and are assessed in parallel. 
• 6-Month Follow-up (Month 6, end of study): At the end of the 6-month study period, 
all participants undergo the final evaluation. The same battery of outcome measures 
(PHQ-9, FSS, MMSE, Barthel Index, SIS) is administered, and the final fNIRS 
measurement is conducted. The 6-month outcomes represent the primary endpoint for 
evaluating intervention effectiveness. By this time, the intervention group has 
concluded all activities (the last home visit by the physical therapist typically occurs 
around month 5 or 6 with the monthly schedule). We document any post-study referrals 
or ongoing care plans for both groups. After completing the 6-month assessment, 
participants are thanked and exit the study. Those in the control group are offered an 
opportunity to receive the intervention program after study completion, if appropriate, 
as an ethical consideration. 
Sample Size and Justification 
The sample size was determined based on detecting a clinically meaningful difference in 
depression outcomes between the two groups at 6 months. Using a two-sample comparison of 
mean change in PHQ-9 scores (intervention vs control), we assumed a difference in mean PHQ-
9 reduction of approximately 3.43 points with a standard deviation of about 5.5, based on prior 
research on post-stroke depression interventions [27]. With a two-sided α=0.05 and power (1–
β) of 0.80, the estimated minimum sample required was 43 patients per group (calculated via 
the formula for comparing two means). We planned to enroll 46 patients in each group (total 
N=92) to account for potential drop-outs and ensure adequate power. This sample size also 
offers >80% power to detect medium-to-large effects on secondary continuous outcomes like 
FSS and Barthel Index, given similar variance assumptions. The actual achieved sample size 
was 92, which meets these targets. No interim analyses for efficacy were planned (due to the 
relatively short intervention duration and moderate sample size), so the full sample contributes 
to the final analysis. 
Randomization, Allocation Concealment, and Blinding 
Participants who met inclusion criteria and provided consent were randomized into one of the 
two study arms in a 1:1 ratio. Randomization was performed using a computer-generated 
random sequence of group codes (A = Intervention, B = Control). To ensure allocation 
concealment, the group assignments were placed in sequentially numbered, opaque, sealed 
envelopes prepared by an independent researcher not involved in participant recruitment. After 
a participant completed all baseline assessments, the research coordinator opened the next 
envelope to reveal the group assignment and then informed the intervention team accordingly. 
Due to the nature of the behavioral interventions, blinding of participants and intervention 
providers was not feasible. Participants were informed that different rehabilitation strategies 
were being compared but were not explicitly told which arm was considered the experimental 
intervention, to minimize expectation bias. The therapists (counselors and physiotherapists) 
obviously knew whom they were treating, and the control group received no therapist contact, 
so blinding at the provider level did not apply. The primary outcome assessor (the nurse 
conducting follow-up surveys) was not blinded to group by necessity, since participants might 
mention aspects of their care; however, this assessor followed a standardized script and 
objective questionnaires to reduce bias. Importantly, the data analyst/statistician remained 

blinded to group labels during the analysis phase – the groups were coded as non-identifiable 
labels (e.g., “Group X” vs “Group Y”) for statistical analysis, and the key was only revealed 
after primary analyses were completed. This single-blind data analysis helped prevent bias in 
interpretation of results. No formal blinding of outcome adjudication was required since 
outcomes were based on quantitative scales and not subjective clinical adjudication. We 
acknowledge that the open-label design could introduce performance or response bias, but our 
use of objective measures and blinding of the statistician aimed to mitigate these concerns. 
Data Collection, Management, and Quality Control 
All study data were collected in case report forms (CRFs) by the research staff at each visit. 
Baseline CRFs captured demographics and clinical history, while follow-up CRFs captured 
outcome assessments and any adverse events or additional treatments. Each participant was 
assigned a unique study ID; all data and samples (if any) were labeled with this ID to maintain 
confidentiality. The completed CRFs were double-checked by the study coordinator for 
completeness and accuracy after each visit. Data from CRFs were entered into a secure 
electronic database (password-protected) by two independent data entry personnel, with a third 
person performing comparisons to resolve any discrepancies (double data entry verification). 
The electronic dataset did not contain personal identifiers; a master link file connecting IDs to 
patient names was kept separately by the PI in a locked file. 
Participants’ intervention adherence was monitored through session attendance logs, therapist 
records, and patient diaries (for home exercises). MI session attendance and quality were 
further monitored via the audio-recordings and supervision described earlier. Physical therapy 
home visit reports were reviewed weekly by the principal investigator to ensure the 
rehabilitation content was delivered as per protocol and to note any significant issues or 
deviations. Any protocol deviations or unexpected events were documented and discussed in 
weekly research team meetings. 
Data quality control included range checks for data values (e.g., valid score ranges for 
questionnaires), and periodic audits of the consent forms and source data against the database 
entries. All original consent forms and paper records are stored in a locked cabinet in the 
Institute for Preventive Medicine and Public Health at Hanoi Medical University. Only the PI 
and authorized study team members have access to the keys and database password. We 
ensured compliance with Good Clinical Practice (GCP) guidelines in handling the data. 
After study completion, the database will be locked and exported for analysis. The final de-
identified dataset will be archived at Hanoi Medical University for a minimum of 5 years. Any 
blood samples or imaging data (if applicable, e.g. raw fNIRS recordings) will be stored without 
identifiers and used only for the purposes outlined in the study (with any future use requiring 
new ethical approval). 
Ethics and Dissemination 
This study protocol was reviewed and approved by the Institutional Review Board for Ethics 
in Biomedical Research at Hanoi Medical University (IRB approval number: 494/GCN-
HDDDNCYHN-DHYHN, dated 05/12/2021). All participants (or their legal guardians for 
those with impaired capacity) provided written informed consent prior to enrollment, consistent 
with the principles of the Declaration of Helsinki. The consent process was conducted in 
Vietnamese, using an IRB-approved information sheet and consent form that explained the 
study aims, procedures, risks, and benefits in lay language. Participants were assured that they 
could withdraw from the study at any time without any effect on their ongoing medical care.  

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