Adolescent Idiopathic ScoliosisNCT05861856
Manual Therapy and Virtual Reality Supported in Patient With Adolescent Idiopathic Scoliosis
A study testing Manual therapy and Virtual reality in people with Adolescent Idiopathic Scoliosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Adolescent Idiopathic Scoliosis is a three-dimensional deformity of the trunk and spine of unknown cause seen in adolescents. There are various conservative treatment methods to treat scoliosis. Manual therapy and exercises are a few of these treatments. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Manual therapy and Virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jul 2023to 12 Nov 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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients diagnosed with AIS
- Age 10-16 years
- Cobb angle was between 10° and 25
- Risser sing did not exceed 4
- Informed consent forms were signed by the parents and children
Who cannot join
- Used brace,
- Had previous spinal surgery, inferior limb length difference,
- Could not exercise due to another injury/diagnosis,
- Had neuromuscular, psychiatric, cardiovascular, respiratory insufficiency and mental disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficiency of Manual Therapy and Virtual Reality Supported Core Stabilization Exercises in Patient With Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis is a three-dimensional deformity of the trunk and spine of unknown cause seen in adolescents. There are various conservative treatment methods to treat scoliosis. Manual therapy and exercises are a few of these treatments. There are studies showing that manual therapy reduces the severity of curvature, increases range of motion, modulates tissue/muscle extensibility, improves soft tissue movement limitation, relieves pain, and increases psychological well-being in scoliosis patients. In order to treat scoliosis, there are various exercise applications that are applied specifically to scoliosis, from physiotherapy applications. Core stabilization is one of the exercise methods that aim to keep the spine in the center.
Virtual reality, on the other hand, is a three-dimensional simulation model that gives its participants the feeling of reality and allows mutual communication with a dynamic environment created by computers. Virtual reality is a method that provides the opportunity to work with task-based techniques by creating stimulating and entertaining environments, using people's interests and motivations. In a study, it was stated that two of the scoliosis-specific exercises were done through video-assisted games, but they stated that there was no difference because the number of exercises was low. Therefore, in this study, it was aimed to apply core stabilization exercises to scoliosis patients with virtual reality application and to investigate their effects on recovery in patients. In addition, it is planned to investigate whether the severity of the curvature in patients decreases further and whether it has an effect on other healing parameters by using the virtual reality treatment application together with manual treatment.
Read the detailed description
Male and female volunteer patients who were diagnosed with "Adolescent Idiopathic Scoliosis" and referred to physical therapy and met the inclusion criteria will be included in the study. Patients whose families and themselves agreed to participate voluntarily in this study will be randomly divided into three groups and included in the study. Virtual reality supported core stabilization exercises (stability enhancing exercises for the muscles around the spine), manual therapy (mobilization for the spine, mobilization and relaxation methods for the soft tissues around the spine) techniques for the second group, and both virtual reality supported core stabilization exercises and exercises for the third group were given to the third group. Manual therapy techniques will also be applied. The treatment program was planned as a total of 16 sessions, 2 days a week for 8 weeks. This study was planned as single-blind for the purpose of impartiality of the evaluation.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Manual therapy, Virtual reality
- Keywords
- Adolescent idiopathic scoliosis, Manual therapy, Virtual reality, Core stabilization exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
Mobilization for the spine, mobilization and relaxation methods for the soft tissues around the spine will be performed.
Virtual realityOther
Virtual reality supported core stabilization exercises will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality group | Active comparator | Virtual reality supported core stabilization exercises will be performed. Receives: Other: Virtual reality |
| Manual therapy group | Active comparator | Mobilization for the spine, mobilization and relaxation methods for the soft tissues around the spine will be performed. Receives: Other: Manual therapy |
| Combine group | Active comparator | Both virtual reality supported core stabilization exercises and manual therapy techniques will be applied. Receives: Other: Manual therapy; Other: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb angle
The most accepted way of scoliosis evaluation is Cobb angle measurement performed on frontal plane x-ray. The Cobb angle is the curvature of the spine, and measuring it is essential for determining the severity of scoliosis, selecting the best course of action, and monitoring the progression or regression of cases following treatment. The Cobb angle measure as the vertically intersecting angle after determining the vertebrae above the apex and below the apex, which are the most tilted from the concave side of the curvature of the spine.
Measured: Change from pretreatment and 8 weeks after treatment.
Angle of Trunk Rotation
It assessed with a Bunnell scoliometer is a type of inclinometer that measures the asymmetry of the degree of axial rotation on both sides of the body. Assessment is in a standing, forward-bending position bent-over position (arms dangling, palms pressed together) with the pelvis horizontal, and subject standing on a foot template
Measured: Change from pretreatment and 8 weeks after treatment.
Secondary outcomes (2)
Walter Reed Visual Assessment Scale
It was designed to measure physical deformity as perceived by patients with idiopathic scoliosis. The scale assesses seven aspects of the deformity: spinal curvature, rib prominence, flank prominence, deformity/alignment of the thorax with respect to the pelvis, trunk imbalance, shoulder asymmetry and scapular asymmetry. Scores for each catagory range from 1 (no deformity) to 5 (the worst deformity), and the total score is generated from the sum of the scores from the seven domains.
Measured: Change from pretreatment and 8 weeks after treatment.
Scoliosis Research Society-22
Scale is a simple and practical quality of life questionnaire specially created for individuals with scoliosis. SRS includes parameters such as pain, self-image/appearance, function/activity, mental health, and satisfaction with treatment. It is also stated that it is effective in evaluating the changes that occur with treatment. The questionnaire has a total of 22 items that are scored from 1 (worst) to 5 (best) for each item.
Measured: Change from pretreatment and 8 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start29 Jul 2023
- Primary completion4 Oct 2023
- Study completion12 Nov 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 Hacettepe UniversityThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylem KÜÇÜK, Hacettepe University
- Investigators
- Eylem Küçük, Principal investigator, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861856
- Sponsor's protocol ID
- HacettepeUEK
- Status last verified
- Nov 2023
- First submitted
- 7 May 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Manual Therapy and Virtual Reality Supported Core Stabilization Exercises in Patient With Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05861856
- Acronym / sponsor ID
- HacettepeUEK
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent idiopathic scoliosis, Manual therapy, Virtual reality, Core stabilization exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 29 Jul 2023 (actual)
- Primary completion
- 4 Oct 2023 (actual)
- Study completion
- 12 Nov 2023 (actual)
- First posted
- 17 May 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.
Adolescent Idiopathic Scoliosis is a three-dimensional deformity of the trunk and spine of unknown cause seen in adolescents. There are various conservative treatment methods to treat scoliosis. Manual therapy and exercises are a few of these treatments. There are studies showing that manual therapy reduces the severity of curvature, increases range of motion, modulates tissue/muscle extensibility, improves soft tissue movement limitation, relieves pain, and increases psychological well-being in scoliosis patients. In order to treat scoliosis, there are various exercise applications that are applied specifically to scoliosis, from physiotherapy applications. Core stabilization is one of the exercise methods that aim to keep the spine in the center.
Virtual reality, on the other hand, is a three-dimensional simulation model that gives its participants the feeling of reality and allows mutual communication with a dynamic environment created by computers. Virtual reality is a method that provides the opportunity to work with task-based techniques by creating stimulating and entertaining environments, using people's interests and motivations. In a study, it was stated that two of the scoliosis-specific exercises were done through video-assisted games, but they stated that there was no difference because the number of exercises was low. Therefore, in this study, it was aimed to apply core stabilization exercises to scoliosis patients with virtual reality application and to investigate their effects on recovery in patients. In addition, it is planned to investigate whether the severity of the curvature in patients decreases further and whether it has an effect on other healing parameters by using the virtual reality treatment application together with manual treatment.
Detailed description
Male and female volunteer patients who were diagnosed with "Adolescent Idiopathic Scoliosis" and referred to physical therapy and met the inclusion criteria will be included in the study. Patients whose families and themselves agreed to participate voluntarily in this study will be randomly divided into three groups and included in the study. Virtual reality supported core stabilization exercises (stability enhancing exercises for the muscles around the spine), manual therapy (mobilization for the spine, mobilization and relaxation methods for the soft tissues around the spine) techniques for the second group, and both virtual reality supported core stabilization exercises and exercises for the third group were given to the third group. Manual therapy techniques will also be applied. The treatment program was planned as a total of 16 sessions, 2 days a week for 8 weeks. This study was planned as single-blind for the purpose of impartiality of the evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual reality group | Active comparator | Other: Virtual realityVirtual reality supported core stabilization exercises will be performed. |
| Manual therapy group | Active comparator | Other: Manual therapyMobilization for the spine, mobilization and relaxation methods for the soft tissues around the spine will be performed. |
| Combine group | Active comparator | Other: Manual therapy, Other: Virtual realityBoth virtual reality supported core stabilization exercises and manual therapy techniques will be applied. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients diagnosed with AIS
- Age 10-16 years
- Cobb angle was between 10° and 25
- Risser sing did not exceed 4
- Informed consent forms were signed by the parents and children
Key exclusion criteria (4 listed)
- Used brace,
- Had previous spinal surgery, inferior limb length difference,
- Could not exercise due to another injury/diagnosis,
- Had neuromuscular, psychiatric, cardiovascular, respiratory insufficiency and mental disability
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 |
|---|---|---|
| Manual therapyMobilization for the spine, mobilization and relaxation methods for the soft tissues around the spine will be performed. | Other | Combine group, Manual therapy group |
| Virtual realityVirtual reality supported core stabilization exercises will be performed. | Other | Combine group, Virtual reality group |
Primary outcome
Cobb angle
Time frame: Change from pretreatment and 8 weeks after treatment.
The most accepted way of scoliosis evaluation is Cobb angle measurement performed on frontal plane x-ray. The Cobb angle is the curvature of the spine, and measuring it is essential for determining the severity of scoliosis, selecting the best course of action, and monitoring the progression or regression of cases following treatment. The Cobb angle measure as the vertically intersecting angle after determining the vertebrae above the apex and below the apex, which are the most tilted from the concave side of the curvature of the spine.
Angle of Trunk Rotation
Time frame: Change from pretreatment and 8 weeks after treatment.
It assessed with a Bunnell scoliometer is a type of inclinometer that measures the asymmetry of the degree of axial rotation on both sides of the body. Assessment is in a standing, forward-bending position bent-over position (arms dangling, palms pressed together) with the pelvis horizontal, and subject standing on a foot template
2 secondary outcomes
Walter Reed Visual Assessment Scale
Time frame: Change from pretreatment and 8 weeks after treatment.
Scoliosis Research Society-22
Time frame: Change from pretreatment and 8 weeks after treatment.
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 28 Nov 2023.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
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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.
Eylem Küçük principal investigator
Amasya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy and Virtual reality in people with Adolescent Idiopathic Scoliosis, run by Hacettepe 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 4 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 28 Nov 2023. 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: Change from pretreatment and 8 weeks after treatment.). 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?
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 28 Nov 2023.