Virtual Reality on Pain and Range of Motion on Burn

NCT05352711 | Completed

• 1 other identifier: P.T.REC/012/003467
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The Purpose of the study is to determine the effect of virtual reality exercise on pain and shoulder range of motion in pediatrics with 2nd-degree anterior shoulder burn injuries.

Conditions

Burns

Keywords

burn injuries

Outcome Measures

Primary Outcomes (6)

• status of ROM for shoulder flexion assessment in day 1

  mobile applications (apps) specifically designed to measure ROM

  Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 1

• change of ROM for shoulder flexion assessment in day 14

  mobile applications (apps) specifically designed to measure ROM

  Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 14

• change of ROM for shoulder flexion assessment in day 28

  mobile applications (apps) specifically designed to measure ROM

  Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 28

• status of shoulder pain assessment in day 1

  Smart phone version of visual analogue scale (VAS) for assessing the pain ,the user touches the line, marking the location along the line that indicates the severity of the pain. An integer score between 0 and 100 is calculated based on the location of the marker relative to the ends of the line.(0 indicates no pain while 100 indicates worest pain)

  evaluate psychometric properties within the distinct targeted samples in day 1

• change of shoulder pain assessment in day 14

  Smart phone version of visual analogue scale (VAS) for assessing the pain ,the user touches the line, marking the location along the line that indicates the severity of the pain. An integer score between 0 and 100 is calculated based on the location of the marker relative to the ends of the line.(0 indicates no pain while 100 indicates worest pain)

  evaluate psychometric properties within the distinct targeted samples in day 14

• change of shoulder pain assessment in day 28

  Smart phone version of visual analogue scale (VAS) for assessing the pain ,the user touches the line, marking the location along the line that indicates the severity of the pain. An integer score between 0 and 100 is calculated based on the location of the marker relative to the ends of the line. (0 indicates no pain while 100 indicates worest pain)

  evaluate psychometric properties within the distinct targeted samples in day 28

Secondary Outcomes (2)

• presentation of an individual's perception of their current health state

  questionnaire is used to asses the quality of patient's life at the first day of treatment

• change in presentation of an individual's perception of their current health state

  this questionnaire will be used to asses the quality of patient's life at the day 28 of treatment

Study Arms (2)

active assisted exercise with Oculus Quest virtual reality (VR) group

EXPERIMENTAL

This group includes 30 patients suffered from pain and loss of shoulder flexion ROM, The patients will treated with active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand controller ) for 30 min. 2 times per week for 4 weeks The ROM will be assessed by mobile goniometer application and Smart phone version of visual analogue scale (VAS) to assess pain and The Quality-of-Life Scale for Children to assess the psychometric properties after the 1st session, day 14 and day 28.

Device: active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand con

active assisted range of motion exercise group

ACTIVE COMPARATOR

This group includes 30 patients suffering from pain and loss of shoulder flexion ROM. Patients will recieve active-assisted ROM physical therapy 2 sessions per week for 4 weeks.

Other: active assisted range of motion exercise

Interventions

active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand con DEVICE

VR is mainly created by generating visual effects through head-mounted display (HMD) systems. An HMD is a device worn on the head or as part of a helmet with a built-in display and lenses, allowing the user to experience the virtual world with the help of a wide viewing angle, head and hand movements tracking as well as objects interacting by controllers.

active assisted exercise with Oculus Quest virtual reality (VR) group

active assisted range of motion exercise OTHER

Patients were treated active assisted ROM physical therapy 2 sessions per week for 4 weeks.

active assisted range of motion exercise group

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age range between 9-16 years.
• Both sexes will participate in the study.
• Patients who suffered from anterior shoulder burns with involvement of axillary fold.
• patient who suffered from second degree burns.
• all patients are acute cases .

You may not qualify if:

• injuries to the face or head
• Injuries in hands
• Cognitive impairment
• A history of severe motion sickness
• Mental health problems.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Orabi hospital for burn and tumors

Cairo, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Amal Mohamed Abd Albaky, Professor

  Vice dean of high education Faculty of Physical Therapy Cairo University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 29, 2022
• Study Start: April 20, 2022
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

EG (1)