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

NCT05004766 | Unknown DMC

• 1 other identifier: HangangSHH-12
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Burns; Pain; Virtual Reality

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• average pain

  baseline

• average pain

  after 10 days training

• cerebral blood flow of prefrontal cortex

  baseline

• cerebral blood flow of prefrontal cortex

  after 10 days training

Study Arms (2)

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.

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.

Interventions

Robot assisted gait training with virtual reality OTHER

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.

virtual reality apply

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• ≤ functional ambulation category (FAC) score ≤ 3

You may not qualify if:

• 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

Sponsors & Collaborators

• Hangang Sacred Heart Hospital: lead
• National Research Foundation of Korea: collaborator

Related Publications (2)

• 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.

  PMID: 32182742 BACKGROUND

• 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.

  PMID: 25820289 BACKGROUND

MeSH Terms

Conditions

Burns; Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Cheong Hoon Seo, M.D.

CONTACT

+82 2 2639 5738; chseomd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 13, 2021
• Study Start: August 20, 2021
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2022
• Last Updated: August 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share