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

Walking Clinical Trial

— fNIRS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03990831
• Other study ID #: HangangSHH-1
• Status: Completed
• Phase: N/A
• Start date: July 9, 2019
• Est. completion date: July 9, 2019

Study information

• Verified date: July 2019
• Source: Hangang Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 9, 2019
• Est. primary completion date: July 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Walking

Intervention

Diagnostic Test:
• Functional near-infrared spectroscopy (fNIRS)
Functional near-infrared spectroscopy (fNIRS) measurement

Locations

Country	Name	City	State
Korea, Republic of	Hangang Sacred Heart Hospital	Seoul	Yeongdeungpo-Ku

Sponsors (2)

Lead Sponsor	Collaborator
Hangang Sacred Heart Hospital	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Al-Yahya E, Johansen-Berg H, Kischka U, Zarei M, Cockburn J, Dawes H. Prefrontal Cortex Activation While Walking Under Dual-Task Conditions in Stroke: A Multimodal Imaging Study. Neurorehabil Neural Repair. 2016 Jul;30(6):591-9. doi: 10.1177/1545968315613864. Epub 2015 Oct 21. — View Citation

Kim HY, Kim EJ, You JSH. Adaptive locomotor network activation during randomized walking speeds using functional near-infrared spectroscopy. Technol Health Care. 2017 Jul 20;25(S1):93-98. doi: 10.3233/THC-171310. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygenated hemoglobin (HbO2) of the prefrontal regions,	identify the location of the normal cortical activation during usual walking	5 minutes