Scoliosis; AdolescenceNCT05762354
Investigation of the Relationship Between Body Image Perception, Proprioception, Cobb Angle and Posture in Individuals With Adolescent Idiopathic Scoliosis
An observational study of Scoliosis; Adolescence and Scoliosis Idiopathic, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
Trial summary
Scoliosis is a three-dimensional torsional deformation of the spine and trunk. Chest deformity and pelvic asymmetry are often seen together with spinal deformity. Adolescent idiopathic scoliosis occurs from the onset of puberty until growth plate closure and is the most common of all scoliosis. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis; Adolescence, Scoliosis Idiopathic
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Aug 2022to 10 Feb 2024
- Phase
- Observational
- 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
Study population: Adolescents Idıopatic Scoliosis
Who may be able to join
- Having been diagnosed with adolescent idiopathic scoliosis by a doctor,
- Not having cognitive, mental and psychological problems,
- Continuing exercise or brace therapy.
Who cannot join
- Having a history of spinal surgery
- Having a type of scoliosis other than idiopathic,
- Presence of musculoskeletal system pathologies,
- Vestibular system disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Scoliosis is a three-dimensional torsional deformation of the spine and trunk. Chest deformity and pelvic asymmetry are often seen together with spinal deformity. Adolescent idiopathic scoliosis occurs from the onset of puberty until growth plate closure and is the most common of all scoliosis. One of the most common deformities among posture disorders is known as scoliosis. The change in load distribution resulting from this three-dimensional deformation causes postural changes in patients with idiopathic scoliosis. According to a study, it is thought that postural control and central information processing efficiency may decrease as the Cobb angle increases in people with scoliosis.
Read the detailed description
Scoliosis, shoulder asymmetry, midline asymmetry, trunk shift and lower extremity length inequality. Therefore, it affects body image perception negatively by limiting physical functions and mobility. In a study conducted with individuals with AIS, it was found that as the Cobb angle increased, body image was adversely affected.
It is also known that during the vertebral growth period in idiopathic scoliosis, postural reflex mechanisms originating from the proprioceptive organs and balance problems are associated with the displacement of the vertebrae. As a result of a study on vestibular effect and proprioception, it is concluded that it would be beneficial to include proprioception, balance and coordination exercises in the treatment of scoliosis. In the current literature review, no study was found that investigated the relationships between Cobb angle, proprioception, body image perception and posture variables in individuals with Adolescent Idiopathic Scoliosis.
The aim of our study is to explain the relationship between some problems accompanied by scoliosis in individuals diagnosed with idiopathic scoliosis. With the results that can be obtained from our study, we aim to explain how posture, proprioception and body image perception are affected in individuals with AIS and to contribute to the exercise programs that can be given to the person in line with these results.
- Conditions
- Scoliosis; Adolescence, Scoliosis Idiopathic
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Scoliosis Group | Adolescent Idıopathic Scoliosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fukuda Step Test
The patient will do a 50 or 100 step counting motion with eyes open and closed. 30 degree rotation or 50 cm displacement for 50 steps relative to the starting position; For 100 steps, 31 turns of 45 degrees and displacement of 100 cm will count as a positive result. The hypoactive side of the labyrinth will be accepted as the patient's turning side. The displacement amount of the person will be measured in cm with the help of a tape measure, and the rotation amount will be measured in degrees with the help of a goniometer and recorded in the evaluation form.
Measured: Baseline
Secondary outcomes (7)
Cobb Degree
It can be measured with the help of a goniometer or digitally as the angle between the lines perpendicular to the parallels drawn on the corpus of the first and last vertebrae participating in the curvature. The 'Cobb' angle is the gold standard in the evaluation of scoliosis.
Measured: Baseline
Trunk Rotation
In the study, evaluations with scoliometer will be performed standing and sitting, in the forward bending position until the trunk is in a horizontal position and the scapula and pelvis are aligned. Vertebral rotation angle values taken from the thoracic, thoracolumbar and lumbar regions will be measured by the training physiotherapist and the highest angular value will be recorded as ATR.
Measured: Baseline
Posterior Trunk Symmetry Index
The POTSI parameter is defined as the sum of six indices: the frontal plane asymmetry index (C7, axilla folds and waist lines) and the three frontal plane height difference indexes (acromions, axilla folds, and waist lines). The POTSI score is calculated by placing the indices on the photograph of the patient transplanted from the posterior.
Measured: Baseline
Walter Reed Visual Assessment Scale
In addition to understanding the visual change caused by scoliosis, the scale used to evaluate the treatment results evaluates the deformity under 7 headings. These; spine curvature, rib protrusion, lumbar protrusion, thorax deformity relative to pelvis, trunk imbalance, shoulder and scapula asymmetry. Each of the domains is scored from 1 to 5 with worsening deformity for increasing scores.
Measured: Baseline
SRS 22 Questionaire
SRS-22 is the most commonly used questionnaire to evaluate quality of life in scoliosis patients. The questionnaire is a simple and practical quality of life questionnaire, which has been translated into our language and has validity and reliability, created specifically for individuals with scoliosis. Each question is scored from 1 (worst) to 5 (best) in the questionnaire, which assesses five domains: function, pain, self-image, mental health (five questions each), and treatment satisfaction (two questions).
Measured: Baseline
Coronal Imbalance
In the frontal plan evaluation, the plumb line is suspended in line with the midline of the sacrum, the deviation from the midline at the C7 level is measured and recorded in the evaluation form in cm. clinical threshold for plumb line distances; It will be 50 mm for C7 and 60 mm for L3.
Measured: Baseline
Sagittal Index
In order to detect deformities that develop different from the neutral, by hanging the pendulum from the point where the dorsal kyphosis is most prominent in the sagittal plane; At C7, T12 and L3 alignments, the distance from the pendulum to the spinous process is measured in cm and will be recorded on the evaluation form. If a value greater than 90 mm is obtained as a result of the sagittal index, which is the sum of C7 and L3, it is accepted that the score obtained is correlated with increased kyphosis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start26 Aug 2022
- Primary completion10 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysem Ecem Ozdemir, Istanbul Gelisim University
- Investigators
- İrem Kurt, Msc., Principal investigator, İstanbul Gelişim Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762354
- Sponsor's protocol ID
- GUS001
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Body Image Perception, Proprioception, Cobb Angle and Posture in Individuals With Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05762354
- Acronym / sponsor ID
- GUS001
- Conditions
- Scoliosis; Adolescence, Scoliosis Idiopathic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 9 Mar 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 torsional deformation of the spine and trunk. Chest deformity and pelvic asymmetry are often seen together with spinal deformity. Adolescent idiopathic scoliosis occurs from the onset of puberty until growth plate closure and is the most common of all scoliosis. One of the most common deformities among posture disorders is known as scoliosis. The change in load distribution resulting from this three-dimensional deformation causes postural changes in patients with idiopathic scoliosis. According to a study, it is thought that postural control and central information processing efficiency may decrease as the Cobb angle increases in people with scoliosis.
Detailed description
Scoliosis, shoulder asymmetry, midline asymmetry, trunk shift and lower extremity length inequality. Therefore, it affects body image perception negatively by limiting physical functions and mobility. In a study conducted with individuals with AIS, it was found that as the Cobb angle increased, body image was adversely affected.
It is also known that during the vertebral growth period in idiopathic scoliosis, postural reflex mechanisms originating from the proprioceptive organs and balance problems are associated with the displacement of the vertebrae. As a result of a study on vestibular effect and proprioception, it is concluded that it would be beneficial to include proprioception, balance and coordination exercises in the treatment of scoliosis. In the current literature review, no study was found that investigated the relationships between Cobb angle, proprioception, body image perception and posture variables in individuals with Adolescent Idiopathic Scoliosis.
The aim of our study is to explain the relationship between some problems accompanied by scoliosis in individuals diagnosed with idiopathic scoliosis. With the results that can be obtained from our study, we aim to explain how posture, proprioception and body image perception are affected in individuals with AIS and to contribute to the exercise programs that can be given to the person in line with these results.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scoliosis Group | – | –Adolescent Idıopathic Scoliosis |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents Idıopatic Scoliosis
Key inclusion criteria (3 listed)
- Having been diagnosed with adolescent idiopathic scoliosis by a doctor,
- Not having cognitive, mental and psychological problems,
- Continuing exercise or brace therapy.
Key exclusion criteria (4 listed)
- Having a history of spinal surgery
- Having a type of scoliosis other than idiopathic,
- Presence of musculoskeletal system pathologies,
- Vestibular system disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fukuda Step Test
Time frame: Baseline
The patient will do a 50 or 100 step counting motion with eyes open and closed. 30 degree rotation or 50 cm displacement for 50 steps relative to the starting position; For 100 steps, 31 turns of 45 degrees and displacement of 100 cm will count as a positive result. The hypoactive side of the labyrinth will be accepted as the patient's turning side. The displacement amount of the person will be measured in cm with the help of a tape measure, and the rotation amount will be measured in degrees with the help of a goniometer and recorded in the evaluation form.
7 secondary outcomes
Cobb Degree
Time frame: Baseline
Trunk Rotation
Time frame: Baseline
Posterior Trunk Symmetry Index
Time frame: Baseline
Walter Reed Visual Assessment Scale
Time frame: Baseline
SRS 22 Questionaire
Time frame: Baseline
Coronal Imbalance
Time frame: Baseline
Sagittal Index
Time frame: Baseline
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 8 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
İrem Kurt, Msc. principal investigator
İstanbul Gelişim Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis; Adolescence and Scoliosis Idiopathic, run by Istanbul Gelisim 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 3 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 8 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?
Fukuda Step Test (time frame: Baseline). 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 8 Mar 2024.