BurnsNCT05004766
Effects of Virtual Reality Application on Pain Reduction and Cerebral Blood Flow in Robot Training in Burn Patients
A study testing Robot assisted gait training with virtual reality in people with Burns and Pain, run by Hangang Sacred Heart Hospital.
Trial summary
The purpose of this study is to determine whether the application of virtual reality (VR) is effective in reducing training pain in robot-assisted gait training (RAGT) in patients with lower extremity burn. Read more about this study
- Who is it for?
- Ages 19 to 55 years
- Conditions the study is for
- Burns, Pain, Virtual Reality
- What is being tested?
- Robot assisted gait training with virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2021to 31 Mar 2022
- 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 19 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- partial-to-full-thickness burns that had spontaneously healed or required skin grafting
- all patients rated their most severe pain during robot assisted gati training (RAGT) as a score 5 or higher on a visual analog scale of 0 to 10, where 0 represents no pain at all, and 10 represents worst pain.
- 1 ≤ functional ambulation category (FAC) score ≤ 3
Who cannot join
- patients with history of brain injury
- cognitive disorders, intellectual impairment before burn injury
- problems with weight bearing due to unstable fractures
- body weight ≥100 kg
- severe fixed contracture
- skin disorders that could be worsened by RAGT and conventional rehabilitation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Virtual Reality Application on Pain Reduction and Cerebral Blood Flow in Robot-Assisted Gait Training in Burn Patients : Pilot Study
The purpose of this study is to determine whether the application of virtual reality (VR) is effective in reducing training pain in robot-assisted gait training (RAGT) in patients with lower extremity burn. The investigators investigated through an analysis of the activation status over time in the prefrontal cortex using functional near-infrared spectroscopy (NIRS).
Read the detailed description
Burn injuries and their treatment are considered to be among the most painful a person can endure. Therefore, new modalities that prove effective with burn patients are expected to improve clinical outcomes when applied to painful therapies. The purpose of this study is to determine whether the application of virtual reality (VR) is effective in reducing training pain in robot-assisted gait training (RAGT) in patients with lower extremity burn. The investigators investigated through an analysis of the activation status over time in the prefrontal cortex using functional near-infrared spectroscopy (NIRS). RAGT was performed 10 times for 2 weeks from Monday to Friday, and the cerebral blood flow measurement using NIRS was measured 3 times each while applying or not applying VR for 30 minutes as long as the RAGT is in progress. The VR program provided non-immersive VR walking along a forest path or a coastal path according to the walking speed while the RAGT was in progress. For each physical therapy session, each patient spent equal amounts of time in VR and in the control condition (without VR). The average of oxy-Hb and deoxy-Hb of each session was measured for 10 days. In the prefrontal cortex, the levels of hemoglobin (Hb) were measured using the fNIRS measurement system. Average values of both oxy-Hb and deoxy-Hb were calculated at four stages : temporal delay time with RAGT, RAGT without VR, temporal delay time with VR, RAGT with VR. Before training, all patients verbally rated their most severe pain during physical training as a score of 5 or higher on a visual analog scale (VAS) of 0 to 10, where 0 presents " no pain at all" and 10 presents " worst pain". Pain, the primary dependent variable, was measured immediately after each experimental treatment. Patient rated (1) their worst pain (no pain to worst pain), and (2) their average pain ( no pain or worst pain).
- Conditions
- Burns, Pain, Virtual Reality
- Being tested
- Robot assisted gait training with virtual reality
- Keywords
- burns, pain, virtual reality, robot assisted hait training, functional near infrared spectroscopy
- Medical subject headings
- Burns, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assisted gait training with virtual realityOther
Using the VR system during robot training, the auditory stimulation of VR was applied along with the image of walking of a forest road or coastal road at the same speed as the robot walking speed. The VR programs are a composition of scenic beaty with sounds of nature. Each program is a blend of scenes such as the ocean, desert, forest, flowers, waterfalls, and wildlife.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality apply | Experimental | Using the VR system during robot training, the auditory stimulation of VR was applied along with the image of walking of a forest road or coastal road at the same speed as the robot walking speed. The VR programs are a composition of scenic beaty with sounds of nature. Each program is a blend of scenes such as the ocean, desert, forest, flowers, waterfalls, and wildlife. Receives: Other: Robot assisted gait training with virtual reality |
| control condition | No intervention | Each patient participated in the control condition, during which he or she performed RAGT with no distraction for the same amount of time spent doing therapy in VR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
worst pain score
0 presents " no pain at all" and 10 presents "worst pain".
Measured: baseline
worst pain score
0 presents " no pain at all" and 10 presents "worst pain".
Measured: after 10 days training
Secondary outcomes (4)
average pain
0 presents " no pain at all" and 10 presents "worst pain".
Measured: baseline
average pain
0 presents " no pain at all" and 10 presents "worst pain".
Measured: after 10 days training
cerebral blood flow of prefrontal cortex
oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (HbR) concentration will be measured using an fNIRS device (NIRSIT®; OBELAB Inc., Seoul, Korea) while the participants is training with exoskeleton robot.
Measured: baseline
cerebral blood flow of prefrontal cortex
oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (HbR) concentration will be measured using an fNIRS device (NIRSIT®; OBELAB Inc., Seoul, Korea) while the participants is training with exoskeleton robot.
Measured: after 10 days training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start20 Aug 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
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 BurnsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangang Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004766
- Sponsor's protocol ID
- HangangSHH-12
- Status last verified
- Jul 2021
- First submitted
- 29 Jul 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joo SY, Cho YS, Lee SY, Seok H, Seo CH. Effects of Virtual Reality-Based Rehabilitation on Burned Hands: A Prospective, Randomized, Single-Blind Study. J Clin Med. 2020 Mar 9;9(3):731. doi: 10.3390/jcm9030731.
PubMed 32182742Yucel MA, Aasted CM, Petkov MP, Borsook D, Boas DA, Becerra L. Specificity of hemodynamic brain responses to painful stimuli: a functional near-infrared spectroscopy study. Sci Rep. 2015 Mar 30;5:9469. doi: 10.1038/srep09469.
PubMed 25820289
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Application on Pain Reduction and Cerebral Blood Flow in Robot-Assisted Gait Training in Burn Patients : Pilot Study
- ClinicalTrials.gov ID
- NCT05004766
- Acronym / sponsor ID
- HangangSHH-12
- Conditions
- Burns, Pain, Virtual Reality
- Keywords
- burns, pain, virtual reality, robot assisted hait training, functional near infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hangang Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 20 Aug 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 13 Aug 2021 (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.
The purpose of this study is to determine whether the application of virtual reality (VR) is effective in reducing training pain in robot-assisted gait training (RAGT) in patients with lower extremity burn. The investigators investigated through an analysis of the activation status over time in the prefrontal cortex using functional near-infrared spectroscopy (NIRS).
Detailed description
Burn injuries and their treatment are considered to be among the most painful a person can endure. Therefore, new modalities that prove effective with burn patients are expected to improve clinical outcomes when applied to painful therapies. The purpose of this study is to determine whether the application of virtual reality (VR) is effective in reducing training pain in robot-assisted gait training (RAGT) in patients with lower extremity burn. The investigators investigated through an analysis of the activation status over time in the prefrontal cortex using functional near-infrared spectroscopy (NIRS). RAGT was performed 10 times for 2 weeks from Monday to Friday, and the cerebral blood flow measurement using NIRS was measured 3 times each while applying or not applying VR for 30 minutes as long as the RAGT is in progress. The VR program provided non-immersive VR walking along a forest path or a coastal path according to the walking speed while the RAGT was in progress. For each physical therapy session, each patient spent equal amounts of time in VR and in the control condition (without VR). The average of oxy-Hb and deoxy-Hb of each session was measured for 10 days. In the prefrontal cortex, the levels of hemoglobin (Hb) were measured using the fNIRS measurement system. Average values of both oxy-Hb and deoxy-Hb were calculated at four stages : temporal delay time with RAGT, RAGT without VR, temporal delay time with VR, RAGT with VR. Before training, all patients verbally rated their most severe pain during physical training as a score of 5 or higher on a visual analog scale (VAS) of 0 to 10, where 0 presents " no pain at all" and 10 presents " worst pain". Pain, the primary dependent variable, was measured immediately after each experimental treatment. Patient rated (1) their worst pain (no pain to worst pain), and (2) their average pain ( no pain or worst pain).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality apply | Experimental | Other: Robot assisted gait training with virtual realityUsing the VR system during robot training, the auditory stimulation of VR was applied along with the image of walking of a forest road or coastal road at the same speed as the robot walking speed. The VR programs are a composition of scenic beaty with sounds of nature. Each program is a blend of scenes such as the ocean, desert, forest, flowers, waterfalls, and wildlife. |
| control condition | No intervention | –Each patient participated in the control condition, during which he or she performed RAGT with no distraction for the same amount of time spent doing therapy in VR. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- partial-to-full-thickness burns that had spontaneously healed or required skin grafting
- all patients rated their most severe pain during robot assisted gati training (RAGT) as a score 5 or higher on a visual analog scale of 0 to 10, where 0 represents no pain at all, and 10 represents worst pain.
- 1 ≤ functional ambulation category (FAC) score ≤ 3
Key exclusion criteria (6 listed)
- patients with history of brain injury
- cognitive disorders, intellectual impairment before burn injury
- problems with weight bearing due to unstable fractures
- body weight ≥100 kg
- severe fixed contracture
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 |
|---|---|---|
| Robot assisted gait training with virtual realityUsing the VR system during robot training, the auditory stimulation of VR was applied along with the image of walking of a forest road or coastal road at the same speed as the robot walking speed. The VR programs are a composition of scenic beaty with sounds of nature. Each program is a blend of scenes such as the ocean, desert, forest, flowers, waterfalls, and wildlife. | Other | virtual reality apply |
Primary outcome
worst pain score
Time frame: baseline
0 presents " no pain at all" and 10 presents "worst pain".
worst pain score
Time frame: after 10 days training
0 presents " no pain at all" and 10 presents "worst pain".
4 secondary outcomes
average pain
Time frame: baseline
average pain
Time frame: after 10 days training
cerebral blood flow of prefrontal cortex
Time frame: baseline
cerebral blood flow of prefrontal cortex
Time frame: after 10 days training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Background: PubMed 32182742Joo SY, Cho YS, Lee SY, Seok H, Seo CH. Effects of Virtual Reality-Based Rehabilitation on Burned Hands: A Prospective, Randomized, Single-Blind Study. J Clin Med. 2020 Mar 9;9(3):731. doi: 10.3390/jcm9030731.
- Background: PubMed 25820289Yucel MA, Aasted CM, Petkov MP, Borsook D, Boas DA, Becerra L. Specificity of hemodynamic brain responses to painful stimuli: a functional near-infrared spectroscopy study. Sci Rep. 2015 Mar 30;5:9469. doi: 10.1038/srep09469.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Robot assisted gait training with virtual reality in people with Burns and Pain, run by Hangang Sacred Heart Hospital.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheong Hoon Seo, M.D. (+82 2 2639 5738, chseomd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
worst pain score (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT05004766, 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 13 Aug 2021.