Adolescent Idiopathic ScoliosisNCT06503575
Adolescent Idiopathic Scoliosis and Body Schema
An observational study of Adolescent Idiopathic Scoliosis and Body Schema, run by Acibadem University at 2 sites in Turkey (Türkiye).
Trial summary
Adolescent idiopathic scoliosis is the most common form of scoliosis. Although an increasing number of studies suggest that an abnormal sensory-motor integration critically contributes to the cause of adolescent idiopathic scoliosis , there is uncertainty about the level of the central nervous system explaining this… Read more about this study
- Who is it for?
- Ages 11 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Body Schema
- What is being tested?
- Assesment
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Sep 2024to 15 May 2025
- How long will I take part?
- 1 Day
- 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 11 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescent idiopathic scoliosis consulting a surgeon and adolescent healthy/untreated population consulting a surgeon
Who may be able to join
- Diagnosis of Adolescent idiopathic scoliosis
- Age <19 years old
- Curve severity over 10°
Who cannot join
- History of spine surgery
- Surgery or trauma
- Secondary scoliosis
- Unable to fill out the questionnaires or attend the physical examination,
- History of musculoskeletal injury in the last six months
- Known systematic and psychological illness
Show all 18Show fewer
- Use of prescription medication
- Inclusion Criteria (adolescent healthy/untreated population)
- -Age < 19 years Matched for age/height/weight (+/-5 years; +/- 10 lbs; +/- 10cm) to a scoliosis participant
- Exclusion Criteria (adolescent healthy/untreated population)
- History of spine surgery
- Spine deformity
- Surgery or trauma
- Primer and Secondary scoliosis
- Unable to fill out the questionnaires or attend the physical examination,
- History of musculoskeletal injury in the last six months
- Known systematic and psychological illness
- Use of prescription medication
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Acibadem University
Istanbul, Turkey, +90
Maslak Acıbadem
Istanbul, Turkey, +90
About this study
Official title: Investigation of Body Schema as Sensorimotor Representation in Adolescent Idiopathic Scoliosis and Comparison With Healthy Individuals-A Case Control Study
Adolescent idiopathic scoliosis is the most common form of scoliosis. Although an increasing number of studies suggest that an abnormal sensory-motor integration critically contributes to the cause of adolescent idiopathic scoliosis , there is uncertainty about the level of the central nervous system explaining this dysfunction. Therefore, the planned master's thesis study aims to compare proprioception, tactile acuity, right-left reasoning ability, motor imagery ability, including the evaluation of body schema, which is a sensorimotor representation in adolescent idiopathic scoliosis patients with healthy individuals. In addition, the relationship of these markers with posture results, body perception and quality of life of individuals with adolescent idiopathic scoliosis will be investigated as a secondary aim.
- Conditions
- Adolescent Idiopathic Scoliosis, Body Schema
- Being tested
- Assesment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssesmentOther
All assessments will be made
| Study group | Role | What they receive |
|---|---|---|
| Patient with adolescent idiopathic scoliosis | Not described Receives: Other: Assesment | |
| Healthy control | Not described Receives: Other: Assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The two-point discrimination test
The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It is a measure of tactile agnosia, or the inability to recognize these two points despite intact cutaneous sensation and proprioception
Measured: Baseline
Left/right discrimination (Lateralization)
Right-Left Discrimination will be evaluated with Recognise™ applications (Back) developed by the "Neuro Orthopedic Institute".
Measured: Baseline
Kinesthetic and Visual Imagery Questionnaire
Motor imagery ability will be assessed with the Kinesthetic and Visual Imagery Questionnaire (KVIQ). The participant gives a score between 1 and 5 for the image he/she imagines: "1 point: no image, 5 points: as clear as the original." This process is repeated for each task and at the end of the survey, kinesthetic imagery score, visual imagery score and total score are calculated.
Measured: Baseline
Lumbar proprioception test
In both groups, thoracic and lumbar repositioning accuracy will be measured and evaluated using the dual inclinometer system.
Measured: Baseline
Pressure Pain Threshold
A digital pressure algometer will be applied to the web space of the foot opposite the trigger point. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold).
Measured: Baseline
Secondary outcomes (4)
4D DIERS FORMETIC
In this study, the newly developed 4D DIERS FORMETIC movable spine and surface topography evaluation device will be used. This device is equipped with a digital network camera that allows measurements at a maximum frequency of up to 50 frames per second. The camera uses CMOS sensors with a resolution of 1280x1024 pixels. Thanks to these sensors and reflective markers, measurements are reconstructed in 3D. Thus, it allows real-time evaluation of posture parameters. Evaluation is done without radiation and without contact.
Measured: baseline
Body Image Disturbance Questionnaire--Scoliosis Version
It is a seven-item instrument that measures body image disturbance. It assesses (1) concern about body part(s) felt to be unattractive; (2) preoccupation with the concern(s); (3) experiences of emotional distress about appearance; (4) impairment in social, occupational, or other areas of functioning; (5) interference with social life, school, job, or role functioning; (6) avoidance of activities because of appearance; and (7) behavioral avoidance10,26. Using a rating scale from 1 to 5 (with 1 = not at all concerned, and 5 = extremely concerned) to measure each of these items and a mean score for the seven items, the BIDQ allows for continuous, quantitative measurement. Higher scores reflect more severe body image disturbance
Measured: Baseline
Walter Reed Visual Assessment Scale
It is a scale that scores the severity of curvature by focusing on the person's perception of posture. It is divided into 7 parameters including body curvature, rib prominence, lumbar prominence, head-rib-pelvis positional relationship, head-pelvis relationship, shoulder level and scapula rotation. A high score means that the perceived deformity is high.
Measured: Baseline
Scoliosis Research Society 22
It is a quality of life questionnaire which consists of 22 questions assessing 5 quality of life domains: Function, Pain, Self-Image, Mental health (5 questions), satisfaction (2 questions). Each category is rated on 5. The categories are summed and divided by 5 to have a total score on 5 points. 5 is the best score and 1 the worst
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start15 Sep 2024
- Primary completion15 Jan 2025
- Study completion15 May 2025
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.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuray Alaca, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503575
- Sponsor's protocol ID
- ATADEK-2024/9/343
- Status last verified
- May 2026
- First submitted
- 10 Jul 2024
- Last updated
- 26 May 2026
- 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Body Schema as Sensorimotor Representation in Adolescent Idiopathic Scoliosis and Comparison With Healthy Individuals-A Case Control Study
- ClinicalTrials.gov ID
- NCT06503575
- Acronym / sponsor ID
- ATADEK-2024/9/343
- Conditions
- Adolescent Idiopathic Scoliosis, Body Schema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 16 Jul 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.
Adolescent idiopathic scoliosis is the most common form of scoliosis. Although an increasing number of studies suggest that an abnormal sensory-motor integration critically contributes to the cause of adolescent idiopathic scoliosis , there is uncertainty about the level of the central nervous system explaining this dysfunction. Therefore, the planned master's thesis study aims to compare proprioception, tactile acuity, right-left reasoning ability, motor imagery ability, including the evaluation of body schema, which is a sensorimotor representation in adolescent idiopathic scoliosis patients with healthy individuals. In addition, the relationship of these markers with posture results, body perception and quality of life of individuals with adolescent idiopathic scoliosis will be investigated as a secondary aim.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with adolescent idiopathic scoliosis | – | Other: Assesment |
| Healthy control | – | Other: Assesment |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescent idiopathic scoliosis consulting a surgeon and adolescent healthy/untreated population consulting a surgeon
Key inclusion criteria (3 listed)
- Diagnosis of Adolescent idiopathic scoliosis
- Age <19 years old
- Curve severity over 10°
Key exclusion criteria (18 listed)
- History of spine surgery
- Surgery or trauma
- Secondary scoliosis
- Unable to fill out the questionnaires or attend the physical examination,
- History of musculoskeletal injury in the last six months
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 |
|---|---|---|
| AssesmentAll assessments will be made | Other | Healthy control, Patient with adolescent idiopathic scoliosis |
Primary outcome
The two-point discrimination test
Time frame: Baseline
The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It is a measure of tactile agnosia, or the inability to recognize these two points despite intact cutaneous sensation and proprioception
Left/right discrimination (Lateralization)
Time frame: Baseline
Right-Left Discrimination will be evaluated with Recognise™ applications (Back) developed by the "Neuro Orthopedic Institute".
Kinesthetic and Visual Imagery Questionnaire
Time frame: Baseline
Motor imagery ability will be assessed with the Kinesthetic and Visual Imagery Questionnaire (KVIQ). The participant gives a score between 1 and 5 for the image he/she imagines: "1 point: no image, 5 points: as clear as the original." This process is repeated for each task and at the end of the survey, kinesthetic imagery score, visual imagery score and total score are calculated.
Lumbar proprioception test
Time frame: Baseline
In both groups, thoracic and lumbar repositioning accuracy will be measured and evaluated using the dual inclinometer system.
Pressure Pain Threshold
Time frame: Baseline
A digital pressure algometer will be applied to the web space of the foot opposite the trigger point. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold).
4 secondary outcomes
4D DIERS FORMETIC
Time frame: baseline
Body Image Disturbance Questionnaire--Scoliosis Version
Time frame: Baseline
Walter Reed Visual Assessment Scale
Time frame: Baseline
Scoliosis Research Society 22
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 26 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis and Body Schema, run by Acibadem University at 2 sites 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 18 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 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The two-point discrimination test (time frame: Baseline). The study lists 5 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 26 May 2026.