Effects of Virtual Reality Application on Pain Reduction and Cerebral Blood Flow in Robot Training in Burn Patients

Study Overview
=================
Brief 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. 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).

Official Title
-----------------
Effects of Virtual Reality Application on Pain Reduction and Cerebral Blood Flow in Robot-Assisted Gait Training in Burn Patients : Pilot Study

Conditions
-----------------
Burns, Pain, Virtual Reality

Intervention / Treatment
-----------------
* Other: Robot assisted gait training with virtual reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: virtual reality apply<br>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. | Other: Robot assisted gait training with virtual reality<br>* 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.<br>|
| No Intervention: control condition<br>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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| worst pain score | 0 presents  no pain at all and 10 presents worst pain. | baseline | 
| worst pain score | 0 presents  no pain at all and 10 presents worst pain. | after 10 days training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average pain | 0 presents  no pain at all and 10 presents worst pain. | baseline | 
| average pain | 0 presents  no pain at all and 10 presents worst pain. | 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. | 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. | after 10 days training | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
burns, pain, virtual reality, robot assisted hait training, functional near infrared spectroscopy