- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05187780
Comparison of Reposition Sense in Scoliosis and Healthy Adolescents
Comparison of Spinal Joint Reposition Sense in Idiopathic Scoliosis and Healthy Adolescents
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ayşe Zengin Aplözgen, PhD
- Email: azengin@istanbul.edu.tr
Study Locations
-
-
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Istanbul, Turkey
- Recruiting
- Istanbul University Cerrahpasa
-
Contact:
- Ayse Zengin Alpozgen, PhD
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1
Adolescents with Idiopathic Scoliosis who have 10⁰-24⁰ Cobb angles
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Group 2
Adolescents with Idiopathic Scoliosis who have 25⁰-40⁰ Cobb angles
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Group 3
Healthy adolescents without scoliosis as controls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of spine joint position reproduction
Time Frame: Baseline
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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. |
Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spinal pain assessment
Time Frame: Baseline
|
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. |
Baseline
|
Physical activity level
Time Frame: Baseline
|
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).
|
Baseline
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Adam's Forward Bending Test
Time Frame: Baseline
|
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.
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Baseline
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Cobb angle assessment
Time Frame: Baseline
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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.
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Baseline
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Flexicurve ruler
Time Frame: Baseline
|
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.
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Baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Ayşe Zengin Aplözgen, PhD, Istanbul University - Cerrahpasa (IUC)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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