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Frontal Lobe Oxyhemoglobin Levels in Patients With Lower Extremity Burns Assessed Using a fNIRS (fNIRS)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Walking | Diagnostic Test: Functional near-infrared spectroscopy (fNIRS) | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 36 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | patients with lower extremity burn : 15 patients patients with upper extremity burn : 10 patients healthy controls : 11 |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| 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 |
| Actual Study Start Date : | July 9, 2019 |
| Actual Primary Completion Date : | July 9, 2019 |
| Actual Study Completion Date : | July 9, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
burn injury and normal patient
HbO2 PFC perfusion using fNIRS
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Diagnostic Test: Functional near-infrared spectroscopy (fNIRS)
Functional near-infrared spectroscopy (fNIRS) measurement
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- oxygenated hemoglobin (HbO2) of the prefrontal regions, [ Time Frame: 5 minutes ]identify the location of the normal cortical activation during usual walking
| Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
| Korea, Republic of | |
| Hangang Sacred Heart Hospital | |
| Seoul, Yeongdeungpo-Ku, Korea, Republic of, 150-719, | |
| Principal Investigator: | Cheong Hoon Seo, M.D. | Hangang Sacred Heart Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | February 21, 2019 | ||||
| First Posted Date ICMJE | June 19, 2019 | ||||
| Last Update Posted Date | July 10, 2019 | ||||
| Actual Study Start Date ICMJE | July 9, 2019 | ||||
| Actual Primary Completion Date | July 9, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
oxygenated hemoglobin (HbO2) of the prefrontal regions, [ Time Frame: 5 minutes ] identify the location of the normal cortical activation during usual walking
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Frontal Lobe Oxyhemoglobin Levels in Patients With Lower Extremity Burns Assessed Using a fNIRS | ||||
| Official Title ICMJE | Frontal Lobe Oxyhemoglobin Levels in Patients With Lower Extremity Burns Assessed Using a Functional Near-Infrared Spectroscopy Device During Usual Walking: A Pilot Study | ||||
| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: patients with lower extremity burn : 15 patients patients with upper extremity burn : 10 patients healthy controls : 11 Masking: None (Open Label)Primary Purpose: Diagnostic |
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| Condition ICMJE | Walking | ||||
| Intervention ICMJE | Diagnostic Test: Functional near-infrared spectroscopy (fNIRS)
Functional near-infrared spectroscopy (fNIRS) measurement
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| Study Arms ICMJE | burn injury and normal patient
HbO2 PFC perfusion using fNIRS
Intervention: Diagnostic Test: Functional near-infrared spectroscopy (fNIRS)
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
36 | ||||
| Original Estimated Enrollment ICMJE |
35 | ||||
| Actual Study Completion Date ICMJE | July 9, 2019 | ||||
| Actual Primary Completion Date | July 9, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years to 60 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Korea, Republic of | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03990831 | ||||
| Other Study ID Numbers ICMJE | HangangSHH-1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | So Young Joo, Hangang Sacred Heart Hospital | ||||
| Study Sponsor ICMJE | Hangang Sacred Heart Hospital | ||||
| Collaborators ICMJE | National Research Foundation of Korea | ||||
| Investigators ICMJE |
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| PRS Account | Hangang Sacred Heart Hospital | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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