Trial results for a multi-intervention program aimed at improving physical and mental health for post-stroke patients were posted on ClinicalTrials.gov on 2025-09-29, showing a mean difference of -7.8 (95% CI: -15.2 to -0.3) for an unspecified outcome, with 92 participants enrolled.

Background

Stroke is a serious medical condition encompassing brain infarction, brain ischemia, cerebral infarction, and other cerebrovascular disorders. Patients often face significant physical and mental health challenges during recovery, impacting their quality of life. This trial aimed to develop a comprehensive management pattern for stroke survivors, focusing on monitoring recovery, early detection of physical and mental disorders, and tailored interventions. The study introduced new intervention techniques in Vietnam, including the use of portable functional near-infrared spectroscopy (fNIRS) to explore cortical frontal hemodynamics and motivational interviewing for psychological adjustment.

Trial design

This completed randomized controlled trial, designated as Phase NA, enrolled 92 participants. The study investigated conditions including Stroke, Brain Infarction, Brain Ischemia, Cerebral Infarction, and Cerebrovascular Disorders. The trial compared a multi-intervention program against standard care, with the goal of improving physical and mental health for post-stroke patients. The multi-intervention program included monitoring recovery, early detection of physical and mental disorders, and individualized interventions, notably incorporating fNIRS and motivational interviewing.

Key results

The trial reported several key measurements and analyses. For the Changes From Baseline Patient Health Questionnaire at 1, 3, and 6 Months (units on a scale), the Multi-intervention Program showed mean scores of 10.9 (Standard Deviation 6.5), 9.1 (Standard Deviation 1.0), 3.1 (Standard Deviation 2.8), and 1.8 (Standard Deviation 1.9). For Standard Care, the mean scores were 10.3 (Standard Deviation 5.9), 19.7 (Standard Deviation 3.8), 24.5 (Standard Deviation 2.8), and 25.6 (Standard Deviation 2.9). For the Fatigue Severity Scale (FSS) (units on a scale), the Multi-intervention Program reported mean scores of 35.2 (Standard Deviation 12.9) and 28.5 (Standard Deviation 11.8), while Standard Care reported mean scores of 37.8 (Standard Deviation 11.4) and 43.4 (Standard Deviation 8.7).

Key analyses using a 2-sided t-test (a=0.05) showed several mean and median differences between the multi-intervention program and standard care. One analysis reported a Mean Difference (Net) of -7.8 (95% CI: -15.2 to -0.3), indicating a statistically significant effect for the intervention group, as its 95% confidence interval did not cross zero. Other analyses included a Median Difference (Net) of 0.6 (95% CI: -1.9 to 3.2) and Mean Differences (Net) of -2.6 (95% CI: -7.6 to 2.5), -2.1 (95% CI: -5.4 to 1.3), 0.1 (95% CI: -14.5 to 14.7), and -7.6 (95% CI: -18.8 to 3.7).

What this means

The results suggest that the multi-intervention program may offer benefits for post-stroke patients, particularly indicated by one statistically significant mean difference of -7.8 (95% CI: -15.2 to -0.3) in a key analysis. While the specific outcome associated with this significant finding is not detailed in the analysis data, the overall aim of the trial was to improve physical and mental health. The reported measurements for the Patient Health Questionnaire and Fatigue Severity Scale show varying trends, with the multi-intervention group generally reporting lower (improved) scores in later measurements for the PHQ and lower FSS scores compared to standard care. The introduction of techniques like fNIRS and motivational interviewing represents an effort to enhance recovery and quality of life for stroke survivors.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04941482, titled "Intervention Effectiveness Towards Improving Physical and Mental Health for Post-stroke Patients.", were posted on 2025-09-29 on clinicaltrials.gov.