NCT03990831

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

July 9, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

Same day

First QC Date

February 21, 2019

Last Update Submit

July 8, 2019

Conditions

Walking

Keywords

BurnNear-infrared spectroscopy (NIRS)

Outcome Measures

Primary Outcomes (1)

  • oxygenated hemoglobin (HbO2) of the prefrontal regions,

    identify the location of the normal cortical activation during usual walking

    5 minutes

Study Arms (1)

burn injury and normal patient

OTHER

HbO2 PFC perfusion using fNIRS

Diagnostic Test: Functional near-infrared spectroscopy (fNIRS)

Interventions

Functional near-infrared spectroscopy (fNIRS)DIAGNOSTIC_TEST

Functional near-infrared spectroscopy (fNIRS) measurement

burn injury and normal patient

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangang Sacred Heart Hospital

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

Location

Related 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.

    PMID: 26493732BACKGROUND

  • 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.

    PMID: 28582896BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Cheong Hoon Seo, M.D.

    Hangang Sacred Heart Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: patients with lower extremity burn : 15 patients patients with upper extremity burn : 10 patients healthy controls : 11
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Rehabilitation Medicine

Study Record Dates

First Submitted

February 21, 2019

First Posted

June 19, 2019

Study Start

July 9, 2019

Primary Completion

July 9, 2019

Study Completion

July 9, 2019

Last Updated

July 10, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)