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

Not Applicable

Completed

• Conditions: Walking
• Interventions: Diagnostic Test: Functional near-infrared spectroscopy (fNIRS)

• Registration Number: NCT03990831
• Lead Sponsor: Hangang Sacred Heart Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Study Start: 2019-07-09
• Primary Completion: 2019-07-09
• Study Completion: 2019-07-09
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
burn injury and normal patient	Functional near-infrared spectroscopy (fNIRS)	HbO2 PFC perfusion using fNIRS

Primary Outcome Measures

Name	Time	Method
oxygenated hemoglobin (HbO2) of the prefrontal regions,	5 minutes	identify the location of the normal cortical activation during usual walking

Trial Locations

Locations (1)

Hangang Sacred Heart Hospital; 🇰🇷 Seoul, Yeongdeungpo-Ku, Korea, Republic of