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

NCT05901792 | Completed

• 1 other identifier: E-74555795-050.01.04-689324
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Body statics; spine; rehabilitation technology; Posture; Virtual Reality Games; Center of gravity; Active video games; Scoliosis; Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

• Center of gravity

  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 Outcomes (4)

• Frontal-sagittal plan posture evaluation

  { 6 weeks}

• Body Symmetry-Posterior

  { 6 weeks}

• Body Symmetry-Anterior

  { 6 weeks}

• Deformity perception assessment

  { 6 weeks}

Study Arms (2)

Virtual Reality Games

EXPERIMENTAL

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

Control group

OTHER

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

Other: Waiting List

Interventions

Virtual Reality Games 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.

Virtual Reality Games

Waiting List 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.

Control group

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Ayse Zengin Alpozgen, Asst. Prof.

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 13, 2023
• Study Start: April 10, 2023
• Primary Completion: September 29, 2023
• Study Completion: September 30, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

TU (1)