N/A
Completed N=92
Intervention Effectiveness Towards Improving Physical and Mental Health for Post-stroke Patients.
Stroke · Brain Infarction · Brain Ischemia · cerebral infarction
Source: ClinicalTrials.gov NCT04941482 ↗
Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months — 10.9; 10.3; 9.1; 19.7 units on a scale — p=<0.05
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months |
10.9; 10.3; 9.1; 19.7; 3.1; 24.5 | <0.05 sig |
| PRIMARY Fatigue Severity Scale (FSS) |
35.2; 37.8; 28.5; 43.4; 17.8; 53.9 | <0.05 sig |
| PRIMARY Changes From Baseline Mini-Mental State Examination at 1, 3, and 6 Months |
16.2; 18.3; 13.5; 18.5; 17.9; 16.2 | <0.05 sig |
| PRIMARY Changes From Baseline Barthel Index at 1, 3, and 6 Months |
55.5; 55.4; 58.8; 55.7; 68.8; 56.2 | <0.05 sig |
| PRIMARY Changes From Baseline of Physical Domain - Stroke Impact Scale at 1, 3, and 6 Months |
36.9; 44.4; 28.4; 37.8; 34.7; 38.2 | <0.05 sig |
| SECONDARY Changes From Baseline of Stroke Impact Scale at 1, 3, and 6 Months |
45.4; 53.2; 48.3; 44.7; 58.5; 40.5 | <0.05 sig |
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
Data sourced from ClinicalTrials.gov (NCT04941482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.