NCT04288414

Brief Summary

To investigate the prognostic value of Functional Near-Infrared Spectroscopy (fNIRS) in stroke rehabilitation with serial measurements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2016

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

8.1 years

First QC Date

July 16, 2019

Last Update Submit

June 30, 2025

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Change of Outcome Prediction Rate

    Outcome prediction rate using fNIRS parameter and clinical parameters.

    After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)

Secondary Outcomes (15)

  • Change of fNIRS activation pattern

    After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)

  • Change of Laterality Index

    After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)

  • Change of National Institutes of Health Stroke Scale (NIHSS) Score

    After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)

  • Change of Glasgow Coma Scale (GCS) Score

    After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)

  • Change of Modified Barthel Index (MBI) Score

    After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)

  • +10 more secondary outcomes

Study Arms (1)

fNIRS applied

All of the participants' brain activity was evaluated with fNIRS.

Diagnostic Test: functional near-infrared spectroscopy

Interventions

functional near-infrared spectroscopyDIAGNOSTIC_TEST

Functional near-infrared spectroscopy (fNIRS) is a non-invasive method that can evaluate the brain function by measuring the change in brain metabolic activity and hemodynamics during a given task with near-infrared spectroscopy.

fNIRS applied

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke patients who are receiving rehabilitation.

You may qualify if:

  • Age 18 or above.
  • Diagnosed as stroke (infarction/hemorrhage) with imaging studies.
  • Participants who have given consent after listening to the full explanations of this study.
  • Able to understand the contents of this study and is able to sign to the written consent by his/herself.

You may not qualify if:

  • Traumatic brain injury.
  • Unable to perform simple commands (motor task during fNIRS scan) due to impaired cognition.
  • Current symptoms are caused by diseases other than stroke (e.g., dementia, Parkinson's disease)
  • Participants with any symptoms that may hinder the compliance or evaluation (e.g., delirium and agitation) process.
  • Participants with any uncontrolled disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital

Seongnam-si, Korea, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nam-Jong Paik, Ph.D

    Seoul National University Bundang Hospital, Seongnam, South Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2019

First Posted

February 28, 2020

Study Start

March 7, 2016

Primary Completion

March 30, 2024

Study Completion

March 31, 2024

Last Updated

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)