WalkingfNIRSNCT03990831
Frontal Lobe Oxyhemoglobin Levels in Patients With Lower Extremity Burns Assessed Using a fNIRS
A study testing Functional near-infrared spectroscopy (fNIRS) in people with Walking, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Investigators investigate the patterns of cortical activation using the NIRST in patients with peripheral neurological injury caused by lower extremity burns. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Walking
- What is being tested?
- Functional near-infrared spectroscopy (fNIRS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Jul 2019to 9 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- burn patients with lower extremity or upper extremity thermal injury
- patients who could walk unassisted for at least 5min.
Who cannot join
- patients with critical systemic conditions
- severe cognitive impairment
- had severe pain
- unable to walk.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hangang Sacred Heart Hospital
Seoul, Yeongdeungpo-Ku, 150-719,
About this study
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
Investigators investigate the patterns of cortical activation using the NIRST in patients with peripheral neurological injury caused by lower extremity burns.
Read the 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.
- Conditions
- Walking
- Being tested
- Functional near-infrared spectroscopy (fNIRS)
- Keywords
- Burn, Near-infrared spectroscopy (NIRS)
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional near-infrared spectroscopy (fNIRS)Diagnostic test
Functional near-infrared spectroscopy (fNIRS) measurement
| Study group | Role | What they receive |
|---|---|---|
| burn injury and normal patient | Other | HbO2 PFC perfusion using fNIRS Receives: Diagnostic Test: Functional near-infrared spectroscopy (fNIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenated hemoglobin (HbO2) of the prefrontal regions,
identify the location of the normal cortical activation during usual walking
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start9 Jul 2019
- Primary completion9 Jul 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for WalkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients with lower extremity burn : 15 patients patients with upper extremity burn : 10 patients healthy controls : 11
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangang Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, So Young Joo, Hangang Sacred Heart Hospital
- Investigators
- Cheong Hoon Seo, M.D., Principal investigator, Hangang Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990831
- Sponsor's protocol ID
- HangangSHH-1
- Acronym
- fNIRS
- Status last verified
- Jul 2019
- First submitted
- 21 Feb 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26493732Kim 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.
PubMed 28582896
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03990831
- Acronym / sponsor ID
- fNIRS / HangangSHH-1
- Conditions
- Walking
- Keywords
- Burn, Near-infrared spectroscopy (NIRS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hangang Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients with lower extremity burn : 15 patients patients with upper extremity burn : 10 patients healthy controls : 11
| Arm | Type | Receives |
|---|---|---|
| burn injury and normal patient | Other | Diagnostic Test: Functional near-infrared spectroscopy (fNIRS)HbO2 PFC perfusion using fNIRS |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- burn patients with lower extremity or upper extremity thermal injury
- patients who could walk unassisted for at least 5min.
Key exclusion criteria (4 listed)
- patients with critical systemic conditions
- severe cognitive impairment
- had severe pain
- unable to walk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional near-infrared spectroscopy (fNIRS)Functional near-infrared spectroscopy (fNIRS) measurement | Diagnostic test | burn injury and normal patient |
Primary outcome
oxygenated hemoglobin (HbO2) of the prefrontal regions,
Time frame: 5 minutes
identify the location of the normal cortical activation during usual walking
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Background: PubMed 26493732Al-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.
- Background: PubMed 28582896Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheong Hoon Seo, M.D. principal investigator
Hangang Sacred Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional near-infrared spectroscopy (fNIRS) in people with Walking, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygenated hemoglobin (HbO2) of the prefrontal regions, (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03990831, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.