Effect of VRGs on Changing the Center of Gravity Location in AIS

March 6, 2024 updated by: Ayse Zengin Alpozgen, Istanbul University - Cerrahpasa (IUC)

The Effect of Virtual Reality Games on Changing the Center of Gravity Location in Children With Adolescent Idiopathic Scoliosis

The purpose of this clinical trial is to examine the effect of virtual reality games (VRG) on changing the location of the center of gravity in children with adolescent idiopathic scoliosis (AIS).

Twenty-four patients with AIS will be randomly allocated to two groups. The intervention group will apply to the virtual reality games and basic correction exercises group for six weeks (18 sessions). The control group will be given the basic correction exercises. Patients' center of gravity (Physiosoft Balance System), posture parameters (PostureScreen Mobile, Posterior Trunk Asymmetry Index (POTSI) and Anterior Trunk Asymmetry Index (ATSI)), cosmetic perception (Walter Reed Visual Evaluation Scale (WRVAS)) will assess at the first session and the end of 6 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The most common type of scoliosis is adolescent idiopathic Scoliosis (AIS). It affects 1-4% of adolescents. AIS is associated with cosmetic problems, pain, functional limitations, respiratory dysfunction and a decrease in quality of life. Although scoliosis is characterized by lateral spinal deviation, it causes a three-dimensional deformity with geometric and morphological changes in the trunk and rib cage. The main changes are postural changes in the orientation of the head, shoulders, scapula and pelvis in all three planes, but more specifically rotations of body segments in the horizontal plane. Spinal deformity not only changes the shape of the trunk, but also the relationships between body segments. Therefore, it leads to an abnormal change in the center of gravity. While various treatment approaches are recommended in the management of AIS to overcome these and other complications, scoliosis-specific corrective exercises are almost always part of the treatment plan for individuals with AIS. However ,Virtual Reality Games (VRGs) have recently been used in health and rehabilitation research due to recent technological developments and changes. In the literature, VRGs have been shown to have a positive effect on changing the position of the center of gravity in different rehabilitation areas. However, there is no study examining the effect of the use of VRGs on the chaning of the center of gravity Location in the treatment of AIS.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University-Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being diagnosed with Adolescent Idiopathic Scoliosis
  • Being the Cobb angle between 10 and 25 degrees on the anteroposterior radiograph
  • Being between the ages of 11 and 18
  • Volunteering to participate in the study

Exclusion Criteria:

  • Having a history of spinal surgery and/or tumors
  • Using braces and insoles
  • Having a positive result of sharpened Romberg and Unterberger test
  • Having orthopedic problems affecting the lower extremities that may affect balance
  • Having problems with vision and/or hearing
  • Having a communication disability
  • Having difficulty with understanding given commands
  • Having neurological or cognitive impairments
  • Receiving conservative treatment for AIS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Games
VRGs group will receive games that focus on changing the position of the body center of gravity and improving balance levels.
Other: Virtual Reality Games
Six different Nintendo Wii Fit Plus games will be employed for six weeks, three days a week, for a total of 18 sessions ranging from 40 to 60 minutes. The games will be chosen from those that emphasize shifting the body's center of gravity. In addition, participants will be given basic correction exercises (derotation, deflexion, basic tension, and lateral flexion 3*3) at the beginning of the study and instructed to practice them at home for six weeks.
Other: Control group
As the control group, the cases on the waiting list will be evaluated.
Other: Waiting List
As the control group, the cases on the waiting list will be evaluated. The control group will be given basic elements of corrective exercises (derotation, deflexion, basic tension, and lateral flexion 3*3) at the start of the study and instructed to practice at home for six weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Center of gravity
Time Frame: { 6 weeks}
The physiosoft Balance System is used to assess the location of the body's center of gravity using the Nintendo Wii Fit balance board. This system was developed by engineers and physiotherapists to measure static balance. The physiosoft Balance System is based on the principle of utilizing the Nintendo Wii Fit system through a computer and developing software specifically designed for objective assessment of balance on a balance board. This system evaluated the static standing balance, center of gravity location and postural oscillations of the participants.
{ 6 weeks}

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frontal-sagittal plan posture evaluation
Time Frame: { 6 weeks}
"PostureScreen Mobile" Application: Frontal and sagittal plan posture evaluation will be calculated by marking the reference points on the anterior, posterior and lateral photographs of the patient in "PostureScreen Mobile" application. The total displacement values in the anterior, posterior and lateral directions for postural impairment will be noted in "cm". Decreasing the total displacement values is considered as an improvement in postural parameters.
{ 6 weeks}
Body Symmetry-Posterior
Time Frame: { 6 weeks}
Posterior Trunk Asymmetry Index (POTSI): The Posterior Trunk Asymmetry Index parameter is defined as the sum of the six indices: the three frontal plane asymmetry index (C7, axilla folds and waist lines) and the three frontal plane height difference index (acromions, axilla folds and waist lines). The Posterior Trunk Asymmetry Index score is calculated by placing the indices on the posterior photo of the patient. The Posterior Trunk Asymmetry Index score, which represents full symmetry, is '0' and the increase in score indicates increased trunk asymmetry.
{ 6 weeks}
Body Symmetry-Anterior
Time Frame: { 6 weeks}
Anterior Trunk Asymmetry Index (ATSI): It is defined as the sum of the six indices determined on the patient's anterior photo: three frontal plane asymmetry indices (stern notch, axilla folds and waist lines) and three frontal plane plane height difference indices (acromions, axilla folds and waist lines). The Anterior Trunk Asymmetry Index score is calculated by placing the indices in the formula. The Anterior Trunk Asymmetry Index score, which represents full symmetry, is '0' and the increase in score indicates increased trunk asymmetry.
{ 6 weeks}
Deformity perception assessment
Time Frame: { 6 weeks}
The Walter Reed Visual Assessment Scale (WRVAS): It is designed to understand the visual change caused by scoliosis and evaluates deformity under 7 headings. There are 5 different pictures that show different degrees of deformity. Each deformity is scored from 1 to 5; "1" is the best, "5" is the worst. The total score is obtained by summing the scores from all titles and dividing them by 7. The score ranges from 1 to 5, and a higher total score means that the perceived deformity is worse.
{ 6 weeks}

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Ayse Zengin Alpozgen, Asst. Prof., Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Actual)

September 29, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-74555795-050.01.04-689324

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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