Scoliosis Idiopathic AdolescentNCT06118814
Body Awareness in Adolescent Idiopatic Scoliosis
A study testing Body Awareness Therapy Exercise, Virtual Reality Exercise and Core Stability Exercise in people with Scoliosis Idiopathic Adolescent and Body Image, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
Scoliosis is a three-dimensional deformity of the spine, and Adolescent Idiopathic Scoliosis (AIS) is the most common subtype of scoliosis. There are various scoliosis-specific exercise programs available for the treatment of scoliosis, and core stabilization is one of the methods aimed at maintaining spinal… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic Adolescent, Body Image
- What is being tested?
- Body Awareness Therapy Exercise, Virtual Reality Exercise and Core Stability Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 10 Aug 2025
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Between the ages of 10 and 18, having a diagnosis of AIS (Adolescent Idiopathic Scoliosis),
- not using a brace,
- having a Cobb angle between 10º-40º,
- being able to regularly attend the prescribed program,
- not having any pulmonary or thoracic cage-related diseases such as rib fractures, atelectasis, or asthma, not having any neurological or psychiatric disorders, and not having a chronic condition requiring medication, and obtaining parental consent for the child's participation in the program.
Who cannot join
- The patient should not have any contraindications for exercise,
- should not have received any scoliosis treatment or undergone spinal surgery within the last year,
- should not be using a brace,
- should not have scoliosis limited only to the cervical region,
- should not have any neuromuscular, cardiovascular, or respiratory function disorder, and should not have cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Virtual Reality Supported Core Stabilization Exercises and Basic Body Awareness Therapy Activities in Individuals With Adolescent Idiopathic Scoliosis
Scoliosis is a three-dimensional deformity of the spine, and Adolescent Idiopathic Scoliosis (AIS) is the most common subtype of scoliosis. There are various scoliosis-specific exercise programs available for the treatment of scoliosis, and core stabilization is one of the methods aimed at maintaining spinal alignment.
Virtual reality offers a method to create stimulating and engaging environments using task-oriented techniques to increase individual interest and motivation. In the literature, virtual reality applications have been used in healthcare to facilitate recovery, post-morbid rehabilitation, and to improve performance in athletes. However, there is limited research on the application of virtual reality therapy for scoliosis patients. One study mentioned the use of two scoliosis-specific exercises through video-assisted games, but the limited exercise repertoire did not make a significant difference. Other video-assisted studies have suggested that exercises targeting posture, balance, and gait can be used for scoliosis patients. Therefore, our study aims to apply core stabilization exercises to scoliosis patients using virtual reality applications and investigate their effects on patient development.
Read more
Although studies examining the effectiveness of core stabilization exercises on body awareness in adolescents with idiopathic scoliosis are limited, they have been reported to be effective in terms of pain, body image, quality of life and functionality.
This study aims to benefit from the therapeutic effects and contribute to the literature by using both different treatment methods. There are four groups in the study. Each group will be evaluated before and after ten weeks of treatment. Participants diagnosed with adolescent idiopathic scoliosis will be randomly assigned to three groups for the study. All participants will be evaluated before and after treatment for curvature severity and rotation angle, trunk flexibility, trunk normal joint range of motion, spine pain, Cosmetic Defect Assessment-Walter Reed Visual Assessment Scale (WRVAS), Quality of Life Assessment-"Scoliosis Research Association-22" (SRS-22) and Child Depression Scale (CDI).
Read the detailed description
After the power analysis, it was planned to include 40 individuals in our study, 10 individuals in each group. The groups of this study will be as follows:
- First group, virtual reality-supported core stabilization exercises (stability-enhancing exercises for the muscles around the spine) and additional home program group,
- Second group, core stabilization exercises (stability-enhancing exercises for the muscles around the spine) and additional home program group,
- Third group, basic body awareness treatment techniques and additional home program group,
- Fourth group is only home program treatment group. The treatment program is planned as a total of 20 sessions for 10 weeks, two days a week. This study was planned as single-blind to ensure the impartiality of the evaluation.
All individuals and their parents who will participate in the study will be verbally informed about the content of the study, its duration, the evaluations to be made, the treatments to be applied and the expected goals to be achieved. Signed consent forms will be obtained from the individuals and their parents indicating that they are willing to participate in the study. The sociodemographic information, physical characteristics, short leg length, age at scoliosis diagnosis, Cobb angle at first diagnosis, curve type and location results of all individuals participating in the study will be recorded. Individuals who do not want to continue the study will be excluded from the study. The study will be completed and the results will be evaluated after the final evaluations of the individuals continuing the study are completed. All participants will be re-evaluated before and after the treatment for their curve severity and rotation angle, trunk flexibility, trunk normal joint range of motion, spinal pain, the Walter Reed Visual Assessment Scale (WRVAS), the Quality of Life Assessment Scale (SRS-22), and the Children's Depression Scale (CDI).
- Conditions
- Scoliosis Idiopathic Adolescent, Body Image
- Being tested
- Body Awareness Therapy Exercise, Virtual Reality Exercise, Core Stability Exercise, Home Exercise
- Keywords
- Scoliosis Idiopathic Adolescent, Body Awareness, Virtual Reality Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Awareness Therapy ExerciseOther
Body awareness therapy exercises were applied to the subjects in this group.
Virtual Reality ExerciseOther
Virtual reality exercises were applied to the subjects in this group.
Core Stability ExerciseOther
Core stabilization exercises were applied to the subjects in this group.
Home ExerciseOther
Subjects in this group implemented a home exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Body Awareness Therapy Group | Experimental | In addition to the home program, basic body awareness exercises will be applied. Receives: Other: Body Awareness Therapy Exercise; Other: Home Exercise |
| Virtual Reality Exercise Group | Experimental | In addition to the home program, virtual reality-supported core stabilization exercises will be applied. Receives: Other: Virtual Reality Exercise; Other: Home Exercise |
| Core Stability Exercise Group | Experimental | In addition to the home program, core stabilization exercises will be performed. Receives: Other: Core Stability Exercise; Other: Home Exercise |
| Home Exercise Group | Active comparator | A home program will be implemented. Receives: Other: Home Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb Angle
Measurements are made to grade scoliosis using the frontal plane radiography using the Cobb method.
Measured: Up to 3 months
Secondary outcomes (6)
Walter Reed Visual Assessment Scale
It is a scale developed to evaluate the physical deformity perceived by patients with scoliosis.
Measured: Up to 3 months
Scoliosis Research Society Questionnare
It is a simple and practical quality of life questionnaire created specifically for individuals with scoliosis. It includes parameters of pain, self-image/appearance, function/activity, mental health, and treatment satisfaction.
Measured: Change from pre treatment and post treatment.
Spinal Pain Assessment
Visual Analog Scale will be used to evaluate spinal pain.
Measured: Up to 3 months
Trunk Muscle Endurance Assessment
Straight plank and side plank tests will be used to evaluate trunk muscle endurance.
Measured: Up to 3 months
Trunk Muscle Strength Assessment
"sit-up test" and "modified push-up test" will be used to evaluate trunk flexor and extensor muscle strength.
Measured: Up to 3 months
Balance Assessment
Y balance balance test will be used for dynamic balance measurement.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Nov 2023
- Primary completion1 Nov 2024
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis Idiopathic AdolescentStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ertugrul Deniz Kose, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118814
- Sponsor's protocol ID
- HititUni
- Status last verified
- Aug 2025
- First submitted
- 29 Oct 2023
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Virtual Reality Supported Core Stabilization Exercises and Basic Body Awareness Therapy Activities in Individuals With Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06118814
- Acronym / sponsor ID
- HititUni
- Conditions
- Scoliosis Idiopathic Adolescent, Body Image
- Keywords
- Scoliosis Idiopathic Adolescent, Body Awareness, Virtual Reality Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 7 Nov 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.
Scoliosis is a three-dimensional deformity of the spine, and Adolescent Idiopathic Scoliosis (AIS) is the most common subtype of scoliosis. There are various scoliosis-specific exercise programs available for the treatment of scoliosis, and core stabilization is one of the methods aimed at maintaining spinal alignment.
Virtual reality offers a method to create stimulating and engaging environments using task-oriented techniques to increase individual interest and motivation. In the literature, virtual reality applications have been used in healthcare to facilitate recovery, post-morbid rehabilitation, and to improve performance in athletes. However, there is limited research on the application of virtual reality therapy for scoliosis patients. One study mentioned the use of two scoliosis-specific exercises through video-assisted games, but the limited exercise repertoire did not make a significant difference. Other video-assisted studies have suggested that exercises targeting posture, balance, and gait can be used for scoliosis patients. Therefore, our study aims to apply core stabilization exercises to scoliosis patients using virtual reality applications and investigate their effects on patient development.
Although studies examining the effectiveness of core stabilization exercises on body awareness in adolescents with idiopathic scoliosis are limited, they have been reported to be effective in terms of pain, body image, quality of life and functionality.
This study aims to benefit from the therapeutic effects and contribute to the literature by using both different treatment methods. There are four groups in the study. Each group will be evaluated before and after ten weeks of treatment. Participants diagnosed with adolescent idiopathic scoliosis will be randomly assigned to three groups for the study. All participants will be evaluated before and after treatment for curvature severity and rotation angle, trunk flexibility, trunk normal joint range of motion, spine pain, Cosmetic Defect Assessment-Walter Reed Visual Assessment Scale (WRVAS), Quality of Life Assessment-"Scoliosis Research Association-22" (SRS-22) and Child Depression Scale (CDI).
Detailed description
After the power analysis, it was planned to include 40 individuals in our study, 10 individuals in each group. The groups of this study will be as follows:
- First group, virtual reality-supported core stabilization exercises (stability-enhancing exercises for the muscles around the spine) and additional home program group,
- Second group, core stabilization exercises (stability-enhancing exercises for the muscles around the spine) and additional home program group,
- Third group, basic body awareness treatment techniques and additional home program group,
- Fourth group is only home program treatment group. The treatment program is planned as a total of 20 sessions for 10 weeks, two days a week. This study was planned as single-blind to ensure the impartiality of the evaluation.
All individuals and their parents who will participate in the study will be verbally informed about the content of the study, its duration, the evaluations to be made, the treatments to be applied and the expected goals to be achieved. Signed consent forms will be obtained from the individuals and their parents indicating that they are willing to participate in the study. The sociodemographic information, physical characteristics, short leg length, age at scoliosis diagnosis, Cobb angle at first diagnosis, curve type and location results of all individuals participating in the study will be recorded. Individuals who do not want to continue the study will be excluded from the study. The study will be completed and the results will be evaluated after the final evaluations of the individuals continuing the study are completed. All participants will be re-evaluated before and after the treatment for their curve severity and rotation angle, trunk flexibility, trunk normal joint range of motion, spinal pain, the Walter Reed Visual Assessment Scale (WRVAS), the Quality of Life Assessment Scale (SRS-22), and the Children's Depression Scale (CDI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Body Awareness Therapy Group | Experimental | Other: Body Awareness Therapy Exercise, Other: Home ExerciseIn addition to the home program, basic body awareness exercises will be applied. |
| Virtual Reality Exercise Group | Experimental | Other: Virtual Reality Exercise, Other: Home ExerciseIn addition to the home program, virtual reality-supported core stabilization exercises will be applied. |
| Core Stability Exercise Group | Experimental | Other: Core Stability Exercise, Other: Home ExerciseIn addition to the home program, core stabilization exercises will be performed. |
| Home Exercise Group | Active comparator | Other: Home ExerciseA home program will be implemented. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Between the ages of 10 and 18, having a diagnosis of AIS (Adolescent Idiopathic Scoliosis),
- not using a brace,
- having a Cobb angle between 10º-40º,
- being able to regularly attend the prescribed program,
- not having any pulmonary or thoracic cage-related diseases such as rib fractures, atelectasis, or asthma, not having any neurological or psychiatric disorders, and not having a chronic condition requiring medication, and obtaining parental consent for the child's participation in the program.
Key exclusion criteria (5 listed)
- The patient should not have any contraindications for exercise,
- should not have received any scoliosis treatment or undergone spinal surgery within the last year,
- should not be using a brace,
- should not have scoliosis limited only to the cervical region,
- should not have any neuromuscular, cardiovascular, or respiratory function disorder, and should not have cognitive impairment.
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 |
|---|---|---|
| Body Awareness Therapy ExerciseBody awareness therapy exercises were applied to the subjects in this group. | Other | Body Awareness Therapy Group |
| Virtual Reality ExerciseVirtual reality exercises were applied to the subjects in this group. | Other | Virtual Reality Exercise Group |
| Core Stability ExerciseCore stabilization exercises were applied to the subjects in this group. | Other | Core Stability Exercise Group |
| Home ExerciseSubjects in this group implemented a home exercise program. | Other | Body Awareness Therapy Group, Core Stability Exercise Group, Home Exercise Group, Virtual Reality Exercise Group |
Primary outcome
Cobb Angle
Time frame: Up to 3 months
Measurements are made to grade scoliosis using the frontal plane radiography using the Cobb method.
6 secondary outcomes
Walter Reed Visual Assessment Scale
Time frame: Up to 3 months
Scoliosis Research Society Questionnare
Time frame: Change from pre treatment and post treatment.
Spinal Pain Assessment
Time frame: Up to 3 months
Trunk Muscle Endurance Assessment
Time frame: Up to 3 months
Trunk Muscle Strength Assessment
Time frame: Up to 3 months
Balance Assessment
Time frame: Up to 3 months
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 17 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Awareness Therapy Exercise, Virtual Reality Exercise and Core Stability Exercise in people with Scoliosis Idiopathic Adolescent and Body Image, run by Hitit University 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 5 inclusion and 5 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 17 Aug 2025. 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?
Cobb Angle (time frame: Up to 3 months). 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 17 Aug 2025.