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Completed

NCT Number: NCT03990831

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

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

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Key information

Conditions

Walking Burns Wounds and Injuries

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hangang Sacred Heart Hospital

Seoul, Yeongdeungpo-Ku, 150-719,, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional near-infrared spectroscopy (fNIRS)

Diagnostic Test

Functional near-infrared spectroscopy (fNIRS) measurement

Primary outcomes

  1. oxygenated hemoglobin (HbO2) of the prefrontal regions,

    Time frame: 5 minutes

    identify the location of the normal cortical activation during usual walking

Sponsors and collaborators

Lead sponsor

Hangang Sacred Heart Hospital

Other

Collaborators

  • National Research Foundation of Korea

Registry information

Official study title

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

Acronym: fNIRS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2019
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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