Immersive Versus Passive Virtual Reality on Upper Limb Pain and Range of Motion in Pediatric Burn

NCT06612892 | Completed

• 1 other identifier: Haitham-005156
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study was to declare the difference between using immersive virtual reality vs passive virtual reality on pain management and improvement of ROM post physiotherapy exercise and mobilization sessions in pediatric burn patients.

Conditions

Virtual Reality; Immersive Virtual Reality; Pediatric Burn; Passive Virtual Reality

Outcome Measures

Primary Outcomes (2)

• assessing the pain intensity using Colored Analog Scale (CAS)

  The Colored Analog Scale (CAS) is a thermometer-like tool that gradually darkens red as you progress, allowing children to indicate their pain levels with markers on the scale's back.

  at baseline and after 6 weeks

• assessing the range of motion using digital goniometer

  The physical therapist will have to measure ROM before and after the intervention to monitor the improvement ,as the study focus on upper limb range of motion , following joints movement will be measured : shoulder flexion and abduction , elbow flexion and extension , wrist flexion and extension , forearm supination and pronation)

  at baseline and after 6 weeks

Study Arms (2)

Immersive virtual reality

EXPERIMENTAL

consisted of 30 patients and received procedure as immersive virtual reality program selected to enhance patient to use his upper limbs in order to interact with the show or game selected

Device: Virtual reality games in immersive VR modality; Other: traditional physiotherapy

Passive virtual reality

ACTIVE COMPARATOR

consisted of 3o patients and received procedure as passive virtual reality program as the patient just wear the headset with a view or show meant only to distract pain while following therapist commands to do active or active assisted upper limbs ROM ex.

Device: Virtual reality show in passive VR modality:; Other: traditional physiotherapy

Interventions

Virtual reality games in immersive VR modality DEVICE

virtual reality involved three characters: a muscular boxer, a superhero, and a rock climber, with patients performing tasks in standing or sitting. Each experience takes 6 minutes, with 5-minute intervals between. Experimenters will instruct users on hand controls and virtual body observation.

Immersive virtual reality

Virtual reality show in passive VR modality: DEVICE

In this modality the patient was asked to have a comfortable seat wearing the head set without holding the controllers , the therapist will play a relaxing show as a nature view or colorful scene as a sort of relaxation and mind distraction for around 20 minutes while asking the patient to perform upper limb muscle ROM exercise in active or active assisted form.

Passive virtual reality

traditional physiotherapy OTHER

Includes stretching exercise for upper limb muscles affected by burn, scar tissue release , and splinting technique.

Immersive virtual reality; Passive virtual reality

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Sixty patients have 2nd degree thermal burn injury, from both genders their ages will be ranged from 7 - 17 years old.
• They will be diagnosed by their physicians with 2nd degree thermal burn injury affecting upper limbs and referred for physical therapy management .
• TBSA calculated up to 9 for one upper limb.
• The patients will be in the acute stage post burn injury; the duration of burn will be 3 weeks post injury.
• Medically and psychologically stable patients

You may not qualify if:

• The potential participants will be excluded if they meet one of the following criteria:
• Cardiac diseases.
• Hand Burn
• Exposed tendons.
• Patients who suffer from skin diseases, diabetes, varicose veins, and peripheral vascular diseases.
• Patients with life threatening disorders as renal failure, myocardial infarction or other similar diseases.
• Patients with facial burn.
• Patients will have an inability to tolerate visual stimulation (e.g., susceptibility to migraines aggravated by light) or inability to tolerate the head mounted display (e.g., sensitivity to touch around the face and head).
• Patients with visual or auditory disorders.
• Patients with unstable fractures.
• Central Nervous System (CNS) problems.
• Patients with medical red flags as severe psychiatric disorder or cognitive deficits .
• Medically unstable and uncooperative patients.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Haytham Mostafa Youssef

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 25, 2024
• Study Start: March 10, 2024
• Primary Completion: June 10, 2024
• Study Completion: September 10, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

EG (1)