Adolescent Idiopathic Scoliosis (AIS)NCT06753383
Effectiveness of Virtual Reality- Based Rehabilitation Program in Individuals With Adolescent Idiopathic Scoliosis After Posterior Fusion Surgery
A study testing To the Virtual Reality Based Exercise and Routine physiotherapy and rehabilitation program in people with Adolescent Idiopathic Scoliosis (AIS), run by Elif Yagmur Ozger at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study is to investigate the effect of virtual reality based rehabilitation program on kinesiophobia, respiratory muscle strength, spinal mobility, physical activity, spinopelvic parameters and quality of life after posterior fusion surgery in individuals diagnosed with Adolescent Idiopathic… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- What is being tested?
- To the Virtual Reality Based Exercise and Routine physiotherapy and rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2024to 20 Feb 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
- Diagnosed with AIS December 10-18
- Underwent posterior spinal fusion surgery
- Post-operative (post-op) 6.during the week and after
- Absence of vision, speech and hearing problems
- Regular participation in the program to be implemented
- Volunteering of individuals
Who cannot join
- Have a history of previous spinal surgery
- Have any contraindications to exercise
- Have a mental problem
- Have a neuromuscular, mesenchymal, rheumatic disease
- Have pulmonary and cardiac complications
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Faculty of Medicine Department of Orthopedics and Traumatology
Istanbul, Fatih, 34093
About this study
The aim of this clinical study is to investigate the effect of virtual reality based rehabilitation program on kinesiophobia, respiratory muscle strength, spinal mobility, physical activity, spinopelvic parameters and quality of life after posterior fusion surgery in individuals diagnosed with Adolescent Idiopathic Scoliosis (AIS). The main questions it aims to answer are:
- Does a virtual reality based rehabilitation program after posterior fusion surgery have an effect on kinesiophobia, respiratory muscle strength, spinal mobility, physical activity, spinopelvic parameters and quality of life in individuals diagnosed with AIS?
- Is the virtual reality-based rehabilitation program after posterior fusion surgery more effective for individuals diagnosed with AIS than the routine physiotherapy and rehabilitation program applied in the clinic?
Read more
They will compare it with the [routine physiotherapy and rehabilitation program] to see if the virtual reality-based rehabilitation program is effective in individuals with AIS after posterior fusion.
Participants :
After being evaluated in terms of kinesiophobia, respiratory muscle strength, spinal mobility, physical activity, spinopelvic parameters and quality of life, the Virtual Reality-Based Exercise Group will be given an exercise program via the games in Kinect Sports Ultimate for 30 minutes a day for a total of 6 weeks, 2 days . At the end of the 6 week, the participants will be re-evaluated and the results will be compared according to the control group.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Being tested
- To the Virtual Reality Based Exercise, Routine physiotherapy and rehabilitation program
- Keywords
- Adolescent Idiopathic Scoliosis, virtual reality based rehabilitation, Respiratory Muscle Strength, Posterior Fusion Surgery, spinal mobility, kinesiophobia, spinopelvic parameter
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To the Virtual Reality Based ExerciseOther
After posterior fusion surgery, a rehabilitation program will be applied to individuals with AIS using Kinect Sports Ultimate for 30 minutes per day for a total of 6 weeks, 2 days a week.
Routine physiotherapy and rehabilitation programOther
14 patients with posterior fusion AIS routinely in the postoperative clinic for 6 weeks. the physiotherapy program used will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Based Exercise Group | Experimental | The Virtual Reality Based Exercise Group will be given an exercise program based on the games in Kinect Sports Ultimate (Soccer, Basketball, Skiing, Tennis, Baseball, Volleyball, Boxing, Track \& Field) for 30 minutes a day for a total of 6 weeks, 2 days a week. The games include movements such as lateral flexion, extension and flexion of the torso and upper limb movements, running, short-urea standing on one leg, jumping. Receives: Other: To the Virtual Reality Based Exercise |
| Control Group | Active comparator | The participants who make up the control group will be followed up with a routine physiotherapy and rehabilitation program for 6 weeks. Receives: Other: Routine physiotherapy and rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Mobility
The spinal mobility of the participants will be measured with the modified Schober test before and after 6 weeks of treatment. When the person is in an upright position, the lumbosacral junction and 10 cm above will be marked, and a third marker will be placed 5 cm below the lumbosacral junction. After the anterior flexion, which is performed as far forward as possible, the distance between the top and bottom deceleration will be measured and the test will be terminated.
Measured: 6 weeks
Respiratory Muscle Strength
The respiratory muscle strength of the participants will be measured according to the criteria of the American Thoracic Society /European Respiratory Society using a portable, electronic intraoral pressure measuring device. After the maximum expiration, the participant will be asked to perform maximal inspiration lasting at least 1.5 seconds in the residual volume. At the total lung capacity after maximum inspiration, the person will be asked to perform a maximum expiration lasting at least 1.5 seconds against the closed system. The tests will be applied in a sitting position with the nose closed with a soft latch. Of at least three measurements that are technically acceptable and do not differ by more than 5 cmH₂O from each other, the highest one will be recorded.
Measured: 6 weeks
Secondary outcomes (4)
Spinopelvic Parameters
All the spinal anterior, posterior and lateral spine ortho x-rays of the participants and spinal parameters and pelvic parameters will be measured before and after virtual reality based rehabilitation applications and the effect of virtual reality based rehabilitation program on the sagittal balance of the spine will be examined
Measured: 6 weeks
Physical Activity
Individuals with AIS will be taught to use pedometers and will be asked to use the device from the moment they get up in the morning until the moment they go to bed at night for 6 weeks, to record the number of steps values before going to bed at night.
Measured: 6 weeks
Kinesiophobia
Participants' fear of movement will be questioned using the TAMPA Kinesiophobia scale. The minimum score that can be taken from the scale is 17 and the maximum score is 68. High scores indicate that the patient's fear of movement is high.
Measured: 6 weeks
Scoliosis Quality of Life
The Scoliosis Research Society-22 Questionnaire (SRS-22) will be used to evaluate the health-related quality of life of individuals with AIS before and after rehabilitation practices performed via virtual reality. The score range for each item ranges from zero (worst) to five (best). Decembers are applied to the following items. The sum of the points received from all the questions will be divided by the total number of questions and the total score will be obtained. A high score indicates that the quality of life is increasing, a low score indicates that it is decreasing.
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 posted31 Dec 2024
- Study start10 Jul 2024
- Primary completion7 Jan 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elif Yagmur Ozger
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Sponsor-investigator, Elif Yagmur Ozger, Istanbul University - Cerrahpasa
- Investigators
- Berk NIMETOGLU, Medical Doctor, Study chair, Istanbul University Faculty of Medicine Department of Orthopedics and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753383
- Sponsor's protocol ID
- 2023/2091
- Status last verified
- Jul 2025
- First submitted
- 16 Dec 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it has been stated that it is necessary to protect the patient information contained in the patient rights regulation, and since the data must be stored, no sharing will be made. If necessary, the data will be shared collectively. Data will not be shared individually.
Publications
Hawes MC. The use of exercises in the treatment of scoliosis: an evidence-based critical review of the literature. Pediatr Rehabil. 2003 Jul-Dec;6(3-4):171-82. doi: 10.1080/0963828032000159202.
PubMed 14713583Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.
PubMed 29435499Dahl-Popolizio S, Loman J, Cordes CC. Comparing Outcomes of Kinect Videogame-Based Occupational/Physical Therapy Versus Usual Care. Games Health J. 2014 Jun;3(3):157-61. doi: 10.1089/g4h.2014.0002. Epub 2014 Apr 17.
PubMed 26196174
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality- Based Rehabilitation Program in Individuals With Adolescent Idiopathic Scoliosis After Posterior Fusion Surgery
- ClinicalTrials.gov ID
- NCT06753383
- Acronym / sponsor ID
- 2023/2091
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- Adolescent Idiopathic Scoliosis, virtual reality based rehabilitation, Respiratory Muscle Strength, Posterior Fusion Surgery, spinal mobility, kinesiophobia, spinopelvic parameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Elif Yagmur OzgerUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 31 Dec 2024 (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 aim of this clinical study is to investigate the effect of virtual reality based rehabilitation program on kinesiophobia, respiratory muscle strength, spinal mobility, physical activity, spinopelvic parameters and quality of life after posterior fusion surgery in individuals diagnosed with Adolescent Idiopathic Scoliosis (AIS). The main questions it aims to answer are:
- Does a virtual reality based rehabilitation program after posterior fusion surgery have an effect on kinesiophobia, respiratory muscle strength, spinal mobility, physical activity, spinopelvic parameters and quality of life in individuals diagnosed with AIS?
- Is the virtual reality-based rehabilitation program after posterior fusion surgery more effective for individuals diagnosed with AIS than the routine physiotherapy and rehabilitation program applied in the clinic?
They will compare it with the [routine physiotherapy and rehabilitation program] to see if the virtual reality-based rehabilitation program is effective in individuals with AIS after posterior fusion.
Participants :
After being evaluated in terms of kinesiophobia, respiratory muscle strength, spinal mobility, physical activity, spinopelvic parameters and quality of life, the Virtual Reality-Based Exercise Group will be given an exercise program via the games in Kinect Sports Ultimate for 30 minutes a day for a total of 6 weeks, 2 days . At the end of the 6 week, the participants will be re-evaluated and the results will be compared according to the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Based Exercise Group | Experimental | Other: To the Virtual Reality Based ExerciseThe Virtual Reality Based Exercise Group will be given an exercise program based on the games in Kinect Sports Ultimate (Soccer, Basketball, Skiing, Tennis, Baseball, Volleyball, Boxing, Track \& Field) for 30 minutes a day for a total of 6 weeks, 2 days a week. The games include movements such as lateral flexion, extension and flexion of the torso and upper limb movements, running, short-urea standing on one leg, jumping. |
| Control Group | Active comparator | Other: Routine physiotherapy and rehabilitation programThe participants who make up the control group will be followed up with a routine physiotherapy and rehabilitation program for 6 weeks. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Diagnosed with AIS December 10-18
- Underwent posterior spinal fusion surgery
- Post-operative (post-op) 6.during the week and after
- Absence of vision, speech and hearing problems
- Regular participation in the program to be implemented
Key exclusion criteria (5 listed)
- Have a history of previous spinal surgery
- Have any contraindications to exercise
- Have a mental problem
- Have a neuromuscular, mesenchymal, rheumatic disease
- Have pulmonary and cardiac complications
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 |
|---|---|---|
| To the Virtual Reality Based ExerciseAfter posterior fusion surgery, a rehabilitation program will be applied to individuals with AIS using Kinect Sports Ultimate for 30 minutes per day for a total of 6 weeks, 2 days a week. | Other | Virtual Reality Based Exercise Group |
| Routine physiotherapy and rehabilitation program14 patients with posterior fusion AIS routinely in the postoperative clinic for 6 weeks. the physiotherapy program used will be applied. | Other | Control Group |
Primary outcome
Spinal Mobility
Time frame: 6 weeks
The spinal mobility of the participants will be measured with the modified Schober test before and after 6 weeks of treatment. When the person is in an upright position, the lumbosacral junction and 10 cm above will be marked, and a third marker will be placed 5 cm below the lumbosacral junction. After the anterior flexion, which is performed as far forward as possible, the distance between the top and bottom deceleration will be measured and the test will be terminated.
Respiratory Muscle Strength
Time frame: 6 weeks
The respiratory muscle strength of the participants will be measured according to the criteria of the American Thoracic Society /European Respiratory Society using a portable, electronic intraoral pressure measuring device. After the maximum expiration, the participant will be asked to perform maximal inspiration lasting at least 1.5 seconds in the residual volume. At the total lung capacity after maximum inspiration, the person will be asked to perform a maximum expiration lasting at least 1.5 seconds against the closed system. The tests will be applied in a sitting position with the nose closed with a soft latch. Of at least three measurements that are technically acceptable and do not differ by more than 5 cmH₂O from each other, the highest one will be recorded.
4 secondary outcomes
Spinopelvic Parameters
Time frame: 6 weeks
Physical Activity
Time frame: 6 weeks
Kinesiophobia
Time frame: 6 weeks
Scoliosis Quality of Life
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 31 Mar 2026.
- Background: PubMed 14713583Hawes MC. The use of exercises in the treatment of scoliosis: an evidence-based critical review of the literature. Pediatr Rehabil. 2003 Jul-Dec;6(3-4):171-82. doi: 10.1080/0963828032000159202.
- Background: PubMed 29435499Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.
- Background: PubMed 26196174Dahl-Popolizio S, Loman J, Cordes CC. Comparing Outcomes of Kinect Videogame-Based Occupational/Physical Therapy Versus Usual Care. Games Health J. 2014 Jun;3(3):157-61. doi: 10.1089/g4h.2014.0002. Epub 2014 Apr 17.
- Individual participant dataSharing planned: No. it has been stated that it is necessary to protect the patient information contained in the patient rights regulation, and since the data must be stored, no sharing will be made. If necessary, the data will be shared collectively. Data will not be shared individually.
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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.
Berk NIMETOGLU, Medical Doctor study chair
Istanbul University Faculty of Medicine Department of Orthopedics and Traumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing To the Virtual Reality Based Exercise and Routine physiotherapy and rehabilitation program in people with Adolescent Idiopathic Scoliosis (AIS), run by Elif Yagmur Ozger 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 6 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 31 Mar 2026. 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?
Spinal Mobility (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06753383, which also lists 3 linked publications.
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 31 Mar 2026.