Comparison of Reposition Sense in Scoliosis and Healthy Adolescents

August 3, 2022 updated by: Ayse Zengin Alpozgen, Istanbul University - Cerrahpasa (IUC)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • İstanbul University Cerrahpaşa
        • Contact:
          • Ayse Zengin Alpozgen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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).

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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.
Baseline
Cobb angle assessment
Time Frame: Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istanbul University
Biruni University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ayşe Zengin Aplözgen, PhD, Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020/01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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