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

Recruiting

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

Observational

Enrollment (Anticipated)

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 Locations

      • Istanbul, Turkey
        • Recruiting
        • Istanbul University Cerrahpasa
        • 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

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 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

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

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.

Investigators

  • 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)

January 22, 2022

Primary Completion (Anticipated)

September 22, 2022

Study Completion (Anticipated)

November 22, 2022

Study Registration Dates

First Submitted

December 24, 2021

First Submitted That Met QC Criteria

December 24, 2021

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID 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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