Frontal Lobe Oxyhemoglobin Levels in Patients With Lower Extremity Burns Assessed Using a fNIRS (fNIRS)

July 8, 2019 updated by: So Young Joo, Hangang Sacred Heart Hospital

Frontal Lobe Oxyhemoglobin Levels in Patients With Lower Extremity Burns Assessed Using a Functional Near-Infrared Spectroscopy Device During Usual Walking: A Pilot Study

Investigators investigate the patterns of cortical activation using the NIRST in patients with peripheral neurological injury caused by lower extremity burns.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Understanding the mechanisms associated with locomotor networks may be of benefit for rehabilitation of burn victims with neurological locomotor deficits. However, the effects of peripheral neurological injury on locomotor network remains unknown. A wearable functional near-infrared spectroscopy (fNIRS) device has been developed for studying cortical hemodynamics. Changes in cortical activity has not previously been documented in patients with burn injury.

Investigators assessed 15 patients with lower extremity burns and 11 healthy controls.

Investigators measured walking-related cortical activity using an fNIRS device at baseline and during usual walking.

Cortical activity was measured by evaluating relative changes in oxyhemoglobin level. The NIRST Analysis Tool v2.1 was utilized to analyze fNIRS data in a MATLAB environment.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Yeongdeungpo-Ku
      • Seoul, Yeongdeungpo-Ku, Korea, Republic of, 150-719,
        • Hangang Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • burn patients with lower extremity or upper extremity thermal injury
  • patients who could walk unassisted for at least 5min.

Exclusion Criteria:

  • patients with critical systemic conditions
  • severe cognitive impairment
  • had severe pain
  • unable to walk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: burn injury and normal patient
HbO2 PFC perfusion using fNIRS
Diagnostic test: Functional near-infrared spectroscopy (fNIRS)
Functional near-infrared spectroscopy (fNIRS) measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oxygenated hemoglobin (HbO2) of the prefrontal regions,
Time Frame: 5 minutes
identify the location of the normal cortical activation during usual walking
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangang Sacred Heart Hospital

Collaborators

National Research Foundation of Korea

Investigators

  • Principal Investigator: Cheong Hoon Seo, M.D., Hangang Sacred Heart Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2019

Primary Completion (Actual)

July 9, 2019

Study Completion (Actual)

July 9, 2019

Study Registration Dates

First Submitted

February 21, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (Actual)

June 19, 2019

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HangangSHH-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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