Prognostic Value for Predicting Outcome Using Functional Near-infrared Spectroscopy in Stroke Rehabilitation

Last updated: June 30, 2025
Sponsor: Seoul National University Bundang Hospital
Overall Status: Completed

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

functional near-infrared spectroscopy

Clinical Study ID

NCT04288414
B-1601/332-003
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 or above.

  • Diagnosed as stroke (infarction/hemorrhage) with imaging studies.

  • Participants who have given consent after listening to the full explanations of thisstudy.

  • Able to understand the contents of this study and is able to sign to the writtenconsent by his/herself.

  • A legal representative has given written consent for those who meet the inclusioncriteria but is unable to understand and agree by themselves due to impairedcognition, a legal representative.

Exclusion

Exclusion Criteria:

  • Traumatic brain injury.

  • Unable to perform simple commands (motor task during fNIRS scan) due to impairedcognition.

  • 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.

Study Design

Total Participants: 23
Treatment Group(s): 1
Primary Treatment: functional near-infrared spectroscopy
Phase:
Study Start date:
March 07, 2016
Estimated Completion Date:
March 31, 2024

Study Description

Serial measurements (immediately after being transferred to rehabilitation department [T0], at discharge from inpatient rehabilitation [T1], and follow up at one to three months from stroke onset [T3]) using Functional Near-Infrared Spectroscopy (fNIRS) was done in all participants. The primary outcome was the outcome prediction rate using fNIRS parameter and clinical parameters. Secondary outcomes were as follows: fNIRS activation pattern, Laterality Index, Functional Connectivity, Fugl-Meyer Score, Modified Barthel Index, , Brunnstrom Stage, Box and Block Test, Grip Strength (handgrip, pinch grip, lateral prehension, three-jaw chuck), Modified Ashworth Scale (wrist flexor and extensor spasticity, elbow flexor, and extensor spasticity, long finger flexor spasticity), modified Rankin Scale score, Functional Ambulation Category, Glasgow Coma Scale, Neglect Evaluation Battery, Korean Version Western Aphasia Battery, and Scale for the Assessment and Rating of Ataxia.

The changes in the fNIRS measurements and clinical parameters will be analyzed and also the correlation between the two will be analyzed to identify the prognostic value of fNIRS.

Connect with a study center

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

    Seongnam-si, Korea, Gyeonggi-do 463-707
    Korea, Republic of

    Site Not Available

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