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

NCT ID: NCT05901792

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2023-09-30

Brief Summary

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.

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.

Conditions

Adolescent Idiopathic Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Games

VRGs group will receive games that focus on changing the position of the body center of gravity and improving balance levels.

Group Type: EXPERIMENTAL

Virtual Reality Games

Intervention Type: OTHER

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.

Control group

As the control group, the cases on the waiting list will be evaluated.

Group Type: OTHER

Waiting List

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Ayse Zengin Alpozgen

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayse Zengin Alpozgen, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-74555795-050.01.04-689324

Identifier Type: -

Identifier Source: org_study_id