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

NCT ID: NCT04288414

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-07

Study Completion Date

2024-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Stroke

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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fNIRS applied

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

functional near-infrared spectroscopy

Intervention Type DIAGNOSTIC_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.

Interventions

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functional near-infrared spectroscopy

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nam-Jong Paik

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nam-Jong Paik, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital, Seongnam, South Korea

Locations

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

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

Site Status

Countries

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South Korea

Other Identifiers

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B-1601/332-003

Identifier Type: -

Identifier Source: org_study_id

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