Scoliosis; AdolescenceNCT05187780
Comparison of Reposition Sense in Scoliosis and Healthy Adolescents
An observational study of Scoliosis; Adolescence and Healthy, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to compare the spine joint reposition sense in adolescent idiopathic scoliosis and healthy adolescents and to investigate whether there is a difference. Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis; Adolescence, Healthy, Proprioception
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jan 2022to 22 Nov 2022
- 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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents with a diagnosis of idiopathic scoliosis between the ages of 10-19, living in Istanbul and their healthy peers will be included in the study. The subjects will be divided into 3 groups: Group 1: Subjects with AIS with 10⁰-24⁰ Cobb angle, Group 2: Subjects with AIS with 25⁰-40⁰ Cobb angle, Group 3: Healthy adolescents in the same age group (control group).
Who may be able to join
- Being between the ages of 10 and 19 years
- Having a Cobb angle of 10-40 degrees measured on the anteroposterior radiograph or a healthy spine alignment (Forward Bend Test < 5⁰ (negative) and Flexicurve Kyphosis Index ≤13)
- No previous conservative approach to scoliosis
- Volunteer to participate in the study
Who cannot join
- Concomitant mental problem, rheumatological, neuromuscular, cardiovascular, pulmonary history
- Any orthopedic disability or severe pain that would preclude evaluations
- Musculoskeletal injury related to the spine in the last 3 months
- Having had spine surgery
- Presence of tumor in the spine
- Loss of vision and/or hearing/presence of vestibular problems
Trial locations and contacts
1 site in 1 country.
Ayşe Zengin Aplözgen, PhD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul University Cerrahpasa
Istanbul
Ayse Zengin Alpozgen, PhD
About this study
Official title: Comparison of Spinal Joint Reposition Sense in Idiopathic Scoliosis and Healthy Adolescents
The aim of the study is to compare the spine joint reposition sense in adolescent idiopathic scoliosis and healthy adolescents and to investigate whether there is a difference.
Read the detailed description
Considering the role of proprioception during activities of daily living and exercises, it is important for clinicians and researchers to determine the joint position senses of adolescents with scoliosis and to compare them with their healthy peers in planning appropriate treatment programs. In the light of this information, the aim of the study is to compare the spine joint reposition sense in adolescent idiopathic scoliosis and healthy adolescents and to investigate whether there is a difference. Patients who were diagnosed with Adolescent Idiopathic Scoliosis (AIS) in the Department of Orthopedics and Traumatology of Istanbul University and who were referred to the Department of Physiotherapy and Rehabilitation of the Faculty of Health Sciences of Istanbul University-Cerrahpaşa and Biruni University and their healthy peers will be included in the study.
- Conditions
- Scoliosis; Adolescence, Healthy, Proprioception
- Keywords
- scoliosis, proprioception, spine
- 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 |
|---|---|---|
| Group 1 | Adolescents with Idiopathic Scoliosis who have 10⁰-24⁰ Cobb angles | |
| Group 2 | Adolescents with Idiopathic Scoliosis who have 25⁰-40⁰ Cobb angles | |
| Group 3 | Healthy adolescents without scoliosis as controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of spine joint position reproduction
Acumar™ Dual Inclinometer:
The subjects will be asked to stay at the reference position for three seconds and then move to the upright position and then go back to the reference angle with their eyes closed. The absolute difference between the two positions in degrees will be noted as the reposition error value. The decrease in the reposition error value is considered as the improvement in the reposition sense.
Measured: Baseline
Secondary outcomes (5)
Spinal pain assessment
Visual Analogue Scale (VAS):
It is used to quantify the pain intensity of patients. Rest, activity, and night pain will be assessed in the study. The condition that there is no pain is expressed as 0, and the condition that there is too much pain to be tolerated is expressed as 10.
Measured: Baseline
Physical activity level
The subjects' physical activity will be assessed with the Physical Activity Questionnaire for Older Children. The questionnaire consists of a total of 9 items (21 activities) that questions the last 7 days with the form of a 5-point Likert-type. The high scores indicate a high physical activity level. Scoring is based on the frequency of the activities, 'never done' (1 point), '1-2 times' (2 points), '3-4 times' (3 points), '5-6 times' (4 points), ' 7 times and more' (5 points).
Measured: Baseline
Adam's Forward Bending Test
The curve for the diagnosis of scoliosis will be analyzed in the Adam's forward bending test. The test will be performed with a scoliometer to measure the degree of rotation of the vertebrae in the horizontal plane in scoliosis. Rotation measured below 5 degrees is considered normal and does not require follow-up.
Measured: Baseline
Cobb angle assessment
The Cobb method has an important role in determining the size of the spinal curve in frontal plane radiography, determining the size of the treatment, and measuring the effectiveness of the treatment. Cobb angle measurement is performed on standard anteroposterior spine radiography. In the measurement, the angle between a line drawn parallel to the upper vertebra joining the curve and a line drawn parallel to the bottom of the lowest vertebra of the same curve is calculated. The increase in the Cobb degree is considered as an indicator of the increase in the severity of the curvature.
Measured: Baseline
Flexicurve ruler
The ruler, which has a plastic and reshapeable structure, is used for the noninvasive measurement of thoracic kyphosis. The tip of the Flexicurve is placed at C7 and shaped caudally to the contour of the thoracic spine. The Flexicurve is then carefully placed on paper and the outline of the shaped thoracic curve is drawn. This process is repeated three times, straightening the ruler between each measurement. The kyphosis index and Flexicurve angle are calculated using the formulas. The kyphosis index is calculated by dividing the apex of kyphosis by the length of the thoracic curve and multiplying by 100. A kyphosis index value greater than 13 is defined as hyperkyphosis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start22 Jan 2022
- Primary completion22 Sep 2022 (estimated)
- Study completion22 Nov 2022 (estimated)
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.
- More trials run by Istanbul University - CerrahpasaThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Biruni University, Istanbul University
- Responsible party
- Principal investigator, Ayse Zengin Alpozgen, Istanbul University - Cerrahpasa
- Investigators
- Ayşe Zengin Aplözgen, PhD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187780
- Sponsor's protocol ID
- 2020/01
- Status last verified
- Aug 2022
- First submitted
- 24 Dec 2021
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Spinal Joint Reposition Sense in Idiopathic Scoliosis and Healthy Adolescents
- ClinicalTrials.gov ID
- NCT05187780
- Acronym / sponsor ID
- 2020/01
- Conditions
- Scoliosis; Adolescence, Healthy, Proprioception
- Keywords
- scoliosis, proprioception, spine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Biruni University, Istanbul University
- Study start
- 22 Jan 2022 (actual)
- Primary completion
- 22 Sep 2022 (estimated)
- Study completion
- 22 Nov 2022 (estimated)
- First posted
- 12 Jan 2022 (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 the study is to compare the spine joint reposition sense in adolescent idiopathic scoliosis and healthy adolescents and to investigate whether there is a difference.
Detailed description
Considering the role of proprioception during activities of daily living and exercises, it is important for clinicians and researchers to determine the joint position senses of adolescents with scoliosis and to compare them with their healthy peers in planning appropriate treatment programs. In the light of this information, the aim of the study is to compare the spine joint reposition sense in adolescent idiopathic scoliosis and healthy adolescents and to investigate whether there is a difference. Patients who were diagnosed with Adolescent Idiopathic Scoliosis (AIS) in the Department of Orthopedics and Traumatology of Istanbul University and who were referred to the Department of Physiotherapy and Rehabilitation of the Faculty of Health Sciences of Istanbul University-Cerrahpaşa and Biruni University and their healthy peers will be included in the study.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Adolescents with Idiopathic Scoliosis who have 10⁰-24⁰ Cobb angles |
| Group 2 | – | –Adolescents with Idiopathic Scoliosis who have 25⁰-40⁰ Cobb angles |
| Group 3 | – | –Healthy adolescents without scoliosis as controls |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with a diagnosis of idiopathic scoliosis between the ages of 10-19, living in Istanbul and their healthy peers will be included in the study. The subjects will be divided into 3 groups: Group 1: Subjects with AIS with 10⁰-24⁰ Cobb angle, Group 2: Subjects with AIS with 25⁰-40⁰ Cobb angle, Group 3: Healthy adolescents in the same age group (control group).
Key inclusion criteria (4 listed)
- Being between the ages of 10 and 19 years
- Having a Cobb angle of 10-40 degrees measured on the anteroposterior radiograph or a healthy spine alignment (Forward Bend Test < 5⁰ (negative) and Flexicurve Kyphosis Index ≤13)
- No previous conservative approach to scoliosis
- Volunteer to participate in the study
Key exclusion criteria (6 listed)
- Concomitant mental problem, rheumatological, neuromuscular, cardiovascular, pulmonary history
- Any orthopedic disability or severe pain that would preclude evaluations
- Musculoskeletal injury related to the spine in the last 3 months
- Having had spine surgery
- Presence of tumor in the spine
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
Evaluation of spine joint position reproduction
Time frame: Baseline
Acumar™ Dual Inclinometer: The subjects will be asked to stay at the reference position for three seconds and then move to the upright position and then go back to the reference angle with their eyes closed. The absolute difference between the two positions in degrees will be noted as the reposition error value. The decrease in the reposition error value is considered as the improvement in the reposition sense.
5 secondary outcomes
Spinal pain assessment
Time frame: Baseline
Physical activity level
Time frame: Baseline
Adam's Forward Bending Test
Time frame: Baseline
Cobb angle assessment
Time frame: Baseline
Flexicurve ruler
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
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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.
Ayşe Zengin Aplözgen, PhD contact
Ayşe Zengin Aplözgen, PhD principal investigator
Istanbul University - Cerrahpasa
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 Healthy, run by Istanbul University - Cerrahpasa 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Begüm KARA KAYA, MSc (+905355720021, bkara@biruni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of spine joint position reproduction (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 4 Aug 2022.