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

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual Reality Games
Waiting List
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Adolescent idiopathic scoliosis, scoliosis, Spinal Curvatures, virtual reality games, Active video games, Center of gravity, Balance, Physiotherapy

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Virtual Reality Games

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Center of gravity
The Fizyosoft (Becure) 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 Becure 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.

Secondary Outcome Measures

Frontal-sagittal plan posture evaluation
"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.
Body Symmetry-Posterior
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.
Body Symmetry-Anterior
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.
Deformity perception assessment
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.

Full Information

First Posted
June 5, 2023
Last Updated
June 13, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05901792
Brief Title
Effect of VRGs on Changing the Center of Gravity Location in Scoliosis
Official Title
The Effect of Virtual Reality Games on Changing the Center of Gravity Location in Children With Adolescent Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 (K -Force plate), 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
Adolescent idiopathic scoliosis, scoliosis, Spinal Curvatures, virtual reality games, Active video games, Center of gravity, Balance, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Masking Description
Single
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Games
Arm Type
Experimental
Arm Description
VRGs group will receive games that focus on changing the position of the body center of gravity and improving balance levels.
Arm Title
Control group
Arm Type
Other
Arm Description
As the control group, the cases on the waiting list will be evaluated.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Games
Intervention Description
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
Intervention Name(s)
Waiting List
Intervention Description
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.
Primary Outcome Measure Information:
Title
Center of gravity
Description
The Fizyosoft (Becure) 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 Becure 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.
Time Frame
{ 6 weeks}
Secondary Outcome Measure Information:
Title
Frontal-sagittal plan posture evaluation
Description
"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.
Time Frame
{ 6 weeks}
Title
Body Symmetry-Posterior
Description
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.
Time Frame
{ 6 weeks}
Title
Body Symmetry-Anterior
Description
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.
Time Frame
{ 6 weeks}
Title
Deformity perception assessment
Description
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.
Time Frame
{ 6 weeks}

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayse Zengin Alpozgen, Asst. Prof.
Phone
+905526830479
Email
azengin@iuc.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Duaa IM Abualkhair, PT
Phone
+905340209617
Email
d.abualkhair@ogr.iuc.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayse Zengin Alpozgen, Asst. Prof.
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayse Zengin Alpozgen, Asst. Prof.
Phone
+905526830479
Email
azengin@iuc.edu.tr
First Name & Middle Initial & Last Name & Degree
Duaa IM Abualkhair, PT
Phone
+905340209617
Email
d.abualkhair@ogr.iuc.edu.tr

12. IPD Sharing Statement

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

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