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

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Seoul National University

Status

Completed

Conditions

Stroke

Treatments

Diagnostic Test: functional near-infrared spectroscopy

Study type

Observational

Funder types

Other

Identifiers

NCT04288414
B-1601/332-003

Details and patient eligibility

About

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

Full 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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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 this study.
  • Able to understand the contents of this study and is able to sign to the written consent by his/herself.
  • A legal representative has given written consent for those who meet the inclusion criteria but is unable to understand and agree by themselves due to impaired cognition, a legal representative.

Exclusion criteria

  • 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.

Trial design

23 participants in 1 patient group

fNIRS applied
Description:
All of the participants' brain activity was evaluated with fNIRS.
Treatment:
Diagnostic Test: functional near-infrared spectroscopy

Trial contacts and locations

1

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Central trial contact

Nam-Jong Paik, Ph.D

Data sourced from clinicaltrials.gov

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