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

Primary Purpose

Burns, Pain, Virtual Reality

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Robot assisted gait training with virtual reality
Sponsored by
Hangang Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring burns, pain, virtual reality, robot assisted hait training, functional near infrared spectroscopy

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    virtual reality apply

    control condition

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    worst pain score
    0 presents " no pain at all" and 10 presents "worst pain".
    worst pain score
    0 presents " no pain at all" and 10 presents "worst pain".

    Secondary Outcome Measures

    average pain
    0 presents " no pain at all" and 10 presents "worst pain".
    average pain
    0 presents " no pain at all" and 10 presents "worst pain".
    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.
    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.

    Full Information

    First Posted
    July 29, 2021
    Last Updated
    August 9, 2021
    Sponsor
    Hangang Sacred Heart Hospital
    Collaborators
    National Research Foundation of Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05004766
    Brief Title
    Effects of Virtual Reality Application on Pain Reduction and Cerebral Blood Flow in Robot Training in Burn Patients
    Official Title
    Effects of Virtual Reality Application on Pain Reduction and Cerebral Blood Flow in Robot-Assisted Gait Training in Burn Patients : Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 20, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    March 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hangang Sacred Heart Hospital
    Collaborators
    National Research Foundation of Korea

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burns, Pain, Virtual Reality
    Keywords
    burns, pain, virtual reality, robot assisted hait training, functional near infrared spectroscopy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    virtual reality apply
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control condition
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Robot assisted gait training with virtual reality
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    worst pain score
    Description
    0 presents " no pain at all" and 10 presents "worst pain".
    Time Frame
    baseline
    Title
    worst pain score
    Description
    0 presents " no pain at all" and 10 presents "worst pain".
    Time Frame
    after 10 days training
    Secondary Outcome Measure Information:
    Title
    average pain
    Description
    0 presents " no pain at all" and 10 presents "worst pain".
    Time Frame
    baseline
    Title
    average pain
    Description
    0 presents " no pain at all" and 10 presents "worst pain".
    Time Frame
    after 10 days training
    Title
    cerebral blood flow of prefrontal cortex
    Description
    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.
    Time Frame
    baseline
    Title
    cerebral blood flow of prefrontal cortex
    Description
    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.
    Time Frame
    after 10 days training

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cheong Hoon Seo, M.D.
    Phone
    +82 2 2639 5738
    Email
    chseomd@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32182742
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25820289
    Citation
    Yucel 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.
    Results Reference
    background

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

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