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

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

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Diagnostic test: functional near-infrared spectroscopy

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 136

Contacts and Locations

• Study Contact: Name: Nam-Jong Paik, Ph.D; Phone Number: 82-31-787-7731; Email: njpaik@snu.ac.kr

Study Locations

• Korea, Republic of
  • Korea, Gyeonggi-do
    • Seongnam-si, Korea, Gyeonggi-do, Korea, Republic of, 463-707
      • Recruiting
      • Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
      • Contact: Nam-Jong Paik, MD, PhD; Phone Number: 82-031-787-7731; Email: njpaik@snu.ac.kr
      • Principal Investigator: Nam-jong Paik, MD, PhD
      • Contact: Ji-Hong Park, MD; Email: parkjihong.md@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Stroke patients who are receiving rehabilitation.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
fNIRS applied; All of the participants' brain activity was evaluated with fNIRS.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of fNIRS activation pattern	The activation pattern was analyzed by nirsLAB software. This software provides data collection and correction function.	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	The formula for Laterality Index is (contralateral - ipsilateral)/(contralateral + ipsilateral). The range of Laterality index is -1 to 1. '-1' means all ipsilateral activation and '1' means all contralateral activation.	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	Tool to quantify the impairment from stroke. On a scale from 0 to 42, 0 is one with no stroke symptoms and 42 is a stroke patient with the most severe symptoms. The 11 items of NIHSS are as follows: level of consciousness, horizontal eye movement, visual field test, facial palsy, motor arm, motor leg, limb ataxia, sensory, language, speech, and extinction and inattention.	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	A neurological scale to evaluate one's consciousness. There are three elements, which are eye response, verbal response, and motor response. A patient with best response will score 15 and a totally unresponsive patient will score 3.	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	The MBI is a scale that measures activities of daily living. It is composed of 10 categories: fecal incontinence, urinary incontinence, grooming, toilet use, feeding, transfers (e.g., from chair to bed), walking, dressing, climbing stairs, and bathing. A higher score is a patient with better ability to live independently.	After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)
Fugl-Meyer Assessment (FMA) Scale	A scale that assess the impairment in a stroke patient. It has three points for each item. When a patient can perform a given task fully, 2 point is given. 1 point is given for partial performance and 0 for not being able to perform the task. The five domains of FMA scale are: motor function (Maximum score in upper limb = 66, Maximum score in lower limb = 34), sensory function (Maximum score = 24), balance (Maximum score = 14), range of motion of joints (Maximum score = 44), and joint pain (Maximum score = 44).	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 Brunnstrom Stage Score	Staging of recovery from stroke. The stages are: 1. flaccidity, 2. developing spasticity, 3. pronounced spasticity, 4. spasticity and influence of synergies start to decrease, 5. spasticity declines even more, and 6. no spasticity and near normal stage.	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 Box and Block Test Score	A test using a box and and blocks to evaluate the upper extremity function.	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 Grip strength	Used JAMAR Hydraulic Hand Dynamometer and JAMAR Hydraulic Pinch Gauge. Hand grip, pinch grip, lateral prehension, and three jaw chuck were measured.	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 Ashworth Scale Score	Measurement of spasticity during passive stretching. Wrist flexor/extensor spasticity, elbow flexor/extensor spasticity, and long finger flexor spasticity were measured. On a scale of 0 to 4, 0 means there is no spasticity and 4 means it is rigid in flexion or extension.	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 Rankin Scale (mRS) Score	A popular validated functional outcome measure in stroke. On a scale from 0 to 6, 0 is one with no symptom and 6 is the worst meaning death.	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 Functional Ambulatory Category (FAC) Score	On a scale from 1 to 6 ambulation status is described. 1 being the worst and 6 being independent at level and non-level surfaces also.	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 Neglect Evaluation Battery Score	Includes Motor Free Visual Perception Test (MVPT), Line Bisection Test, Albert Test, Clock Drawing, Comb and Razor, and Catherine Bergego Scale. Used electrical method if available. Otherwise test was performed.	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 Western Aphasia Battery (WAB)	Measures aphasia type and severity	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 Scale for the Assessment and Rating of Ataxia (SARA)	Clinical scale that assess different impairments in cerebellar ataxia. Consisted of 8 items. It is related to gait, stance, sitting, finger-chase test, nose-finger test, fast alternating movements and heel-shin test.	After 2-3 weeks from stroke onset (T0), Immediately after 2-3 weeks of rehabilitation (T1), After 1-3 months from stroke onset (T2)

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Nam-Jong Paik, Ph.D, Seoul National University Bundang Hospital, Seongnam, South Korea

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2016
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: B-1601/332-003