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

NCT04941482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-09-29

Study results available
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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).

Conditions

  • Stroke
  • Brain Infarction
  • Brain Ischemia
  • Cerebral Infarction
  • Cerebrovascular Disorders

Interventions

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.

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.

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.

Sponsors & Collaborators

  • National Geriatric Hospital

    collaborator OTHER_GOV
  • Hanoi Medical University

    lead OTHER

Principal Investigators

  • Thao TP Nguyen, MD, MSc · Hanoi Medical University, Hanoi 100000, Viet Nam

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-12-30
Completion
2023-06-30

Countries

  • Vietnam

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04941482 on ClinicalTrials.gov