Adolescent Idiopathic ScoliosisNCT05901792
Effect of VRGs on Changing the Center of Gravity Location in AIS
A study testing Virtual Reality Games and Waiting List in people with Adolescent Idiopathic Scoliosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Virtual Reality Games and Waiting List
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Having difficulty with understanding given commands
- Having neurological or cognitive impairments
- Receiving conservative treatment for AIS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Virtual Reality Games, Waiting List
- Keywords
- Body statics, spine, rehabilitation technology, Posture, Virtual Reality Games, Center of gravity, Active video games, Scoliosis, Adolescent Idiopathic Scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GamesOther
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.
Waiting ListOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual Reality Games |
| Control group | Other | As the control group, the cases on the waiting list will be evaluated. Receives: Other: Waiting List |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: { 6 weeks}
Secondary outcomes (4)
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.
Measured: { 6 weeks}
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.
Measured: { 6 weeks}
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.
Measured: { 6 weeks}
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.
Measured: { 6 weeks}
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start10 Apr 2023
- Primary completion29 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Zengin Alpozgen, Istanbul University - Cerrahpasa
- Investigators
- Ayse Zengin Alpozgen, Asst. Prof., Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901792
- Sponsor's protocol ID
- E-74555795-050.01.04-689324
- Status last verified
- Mar 2024
- First submitted
- 5 Jun 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Games on Changing the Center of Gravity Location in Children With Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05901792
- Acronym / sponsor ID
- E-74555795-050.01.04-689324
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Body statics, spine, rehabilitation technology, Posture, Virtual Reality Games, Center of gravity, Active video games, Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Games | Experimental | Other: Virtual Reality GamesVRGs group will receive games that focus on changing the position of the body center of gravity and improving balance levels. |
| Control group | Other | Other: Waiting ListAs the control group, the cases on the waiting list will be evaluated. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality GamesSix 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 | Virtual Reality Games |
| Waiting ListAs 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. | Other | Control group |
Primary outcome
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.
4 secondary outcomes
Frontal-sagittal plan posture evaluation
Time frame: { 6 weeks}
Body Symmetry-Posterior
Time frame: { 6 weeks}
Body Symmetry-Anterior
Time frame: { 6 weeks}
Deformity perception assessment
Time frame: { 6 weeks}
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse Zengin Alpozgen, Asst. Prof. principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Games and Waiting List in people with Adolescent Idiopathic Scoliosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of gravity (time frame: { 6 weeks}). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.