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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05004766
Enrollment
10
Registered
2021-08-13
Start date
2021-08-20
Completion date
2022-03-31
Last updated
2021-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Pain, Virtual Reality

Keywords

burns, pain, virtual reality, robot assisted hait training, functional near infrared spectroscopy

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).

Interventions

OTHERRobot assisted gait training with virtual reality

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.

Sponsors

National Research Foundation of Korea
CollaboratorOTHER
Hangang Sacred Heart Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
worst pain scorebaseline0 presents no pain at all and 10 presents worst pain.

Secondary

MeasureTime frameDescription
average painbaseline0 presents no pain at all and 10 presents worst pain.
cerebral blood flow of prefrontal cortexbaselineoxygenated 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.

Contacts

Primary ContactCheong Hoon Seo, M.D.
chseomd@gmail.com+82 2 2639 5738

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026