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Scoliosis Tele-Screening Test

2021年5月4日 更新者:FİLİZ TUNA、Trakya University

A New Clinical Tool for Scoliosis Risk Analysis: Scoliosis Tele-Screening Test

A new Scoliosis Tele-Screening Test (STS-Test) was developed by a study group of the "Scoliosis Research and Treatment Association Turkey". It will be sent to the families of schoolchildren by e-mail in Turkey. Participants with moderate and high risk for scoliosis according to the result of this test will be invited to the physical examination by the scoliosis specialists, if it is not possible, they will be evaluated via tele-medicine. Participants with moderate and high risks will be invited to the physical examination to the centers designated as research centers. Families who could not reach these centers will be asked to take pictures of their children according to the given instruction. They will be asked to send this photo to the researchers by e-mail. The researchers will be evaluated the TRACE and Adams' test from the photo and sent their opinions to the parents via e-mail. If this virtual analysis made by the expert suggests a suspicion of scoliosis, it will be recommended to see a specialist as soon as possible.

The aim of this study is to evaluate the validity and reliability of this novel scoliosis tele-screening test. A secondary aim is to investigate the coherence of this new test between scoliosis physician and parent when applied to the same child. Specificity, sensitivity, negative predictive value, positive predictive value, and test accuracy will be calculated for the Scoliosis Tele-Screening Test. Correlation between STS-Test and Trace, Adams' test, and physician diagnosis will be analyzed.

研究概览

详细说明

Scoliosis is a three-dimensional spinal and trunk deformity. Adolescent Idiopathic Scoliosis prevalence is 3,1% in females and 1,5% in males in Turkey. Most of the cases are asymptomatic, therefore screening programs are very crucial for early diagnosis especially for cases in risky ages. Early diagnosis provides the early treatment.

Aesthetic evaluation of the trunk is one of the important components of Idiopathic Scoliosis and aesthetic appearance which is the main complaint of the patients and family is the primary aim of the conservative and operative treatment. There are some tools that evaluates postural asymmetries like Trunk Aesthetic Clinical Evaluation which evaluates the shoulder, scapula, waist, and hemithorax and known as a reliable instrument for everyday clinical evaluation and to monitor aesthetic changes achieved with treatment.

A scoliosis screening test has been developed in which families with restricted access to the hospital and healthcare professionals due to the Covid-19 pandemic, can evaluate their children in terms of scoliosis risk without applying to any health institution. A study group of subject experts was formed within the "Scoliosis Research and Treatment Association Turkey". This new tele-screening test could be easily applied by parents at a home in different times, give information about the results to the implementer just after the evaluation. Researchers discussed how to evaluate the spine for scoliosis in a virtual environment and were created a visual screening test. In the scoring of the STS-Test, the images related to the body asymmetry of patients with scoliosis with different deformities characteristics in the common database of these experts were analyzed and scoring was created by expert opinion and consensus.

Scoliosis risk was determined by considering the visual body asymmetries in the shoulder, thorax, waist, and pelvis, in addition, Adams' test. For the girls, female gender and time since menarche as a risk factor were included in the total score. In STS-Test scoring, the positive Adams' test is 4 points for both genders; the presence of family history related to scoliosis is 1 point; female gender was as 1 point; no menarche, or time less than 1-year since menarche for girls, was determined as 1 point. In the scoring of the other items, the anterior shoulder levels and height difference in the pelvis were scored as 2 points; if there was asymmetry in the images of the items including shoulder level difference from the posterior, scapula asymmetry, pelvic shifting to one side and height difference in the pelvis, they were scored as 1 point, and if symmetrical or not able to make a decision, it was scored as 0 points. Scoliosis Tele-Screening Test consists of a total of 23 Likert-type questions; 5 questions about the sociodemographic characteristics of the parents, 3 questions on the knowledge/awareness level regarding scoliosis, 3 questions on the risk factors related to scoliosis development, 7 questions about the cosmetic deformities that scoliosis may cause/can reveal, and 5 questions the satisfaction of the parent/evaluator. The total score for risk groups is based on 7 questions about the cosmetic deformities caused by scoliosis and 3 questions regarding the risk factors associated with scoliosis development. The total score is obtained by summing up the scores from 10 questions of these two sections. The total score is categorized as low, medium, and high risk, and the risk groups differ for males and females. 0-4 points are low, 5-11 points are medium, and 12-15 points are considered a high-risk group for girls in the total score. 0-3 points are low, 4-8 points are medium, and 9-13 points are considered high risk group for males in the total score.

The final version of the test was shared on the website of the Scoliosis Research and Treatment Association Turkey and social networks. After the parent/evaluator completed the test, an e-mail containing information about the test, scoliosis risk score, and recommendations was sent with an automatic reply. Participants with moderate and high risks will be invited to the physical examination to the centers designated as research centers. Families who could not reach these centers will be asked to take pictures of their children according to the given instruction. They will be asked to send this photo to the researchers by e-mail. The researchers will be evaluated the TRACE and Adams' test from the photo and sent their opinions to the parents via e-mail. If this virtual analysis made by the expert suggests a suspicion of scoliosis, it will be recommended to see a specialist as soon as possible. The patients who could apply to the center will be examined by the physician, evaluated cosmetically according to TRACE, and Adams' test will be performed. Suspicion of scoliosis will be confirmed by spine radiography. Patients with a Cobb angle ≥10° in any segment of the spine will be considered to have scoliosis. The location, direction, and angle of scoliosis will be recorded from the spine radiographs.

研究类型

观察性的

注册 (实际的)

865

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Beyoğlu/İstanbul
      • Istanbul、Beyoğlu/İstanbul、火鸡、34445
        • Halic University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

9年 至 16年 (孩子)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Schoolchildren age between 9-16 in Turkey.

描述

Inclusion Criteria:

  • healthy children who agree to voluntarily participate in the study by parents and theirself
  • parents must be literate and have the ability to use the internet

Exclusion Criteria:

  • neurological disease
  • spine surgery history
  • any disease that prevents standing position
  • any cognitive impairment or communication problem

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Accuracy of Scoliosis Tele-Screening Test
大体时间:through study completion, an average of 1 year
Test Accuracy will be obtained using the formula below Test Accuracy/Power = ((TP+TN) / (TP+TN+FP+FN)) * 100 (TP: True positive, TN: True negative, FN:False negative, FP: False positive) Referral criteria for the accuracy of STS-Test based on Adams' test additionally clinician examination
through study completion, an average of 1 year
To investigate the consistency between researchers' assessment and the results of the Scoliosis Tele-Screening Test by the parents for the same case
大体时间:through study completion, an average of 1 year
The agreement between the risk analyzes obtained with the STS-Test performed by the parents and the face-to-face spine assessment by a doctor will be determined. Pearson correlation coefficient will be used to investigate the correlations between parents(via the STS-Test score) and physician assessment. Correlation between parameters will be interpreted as follows: r=0-0.19 a very weak correlation, r=0.20-0.39 weak correlation, r=0.40-0.59 moderate correlation, r=0.60-0.79 strong correlation and r=0.80-1 very strong correlation.
through study completion, an average of 1 year

次要结果测量

结果测量
措施说明
大体时间
Trunk Aesthetic Clinical Evaluation score
大体时间:Baseline
Trunk Aesthetic Clinical Evaluation (TRACE) is a clinical tool developed for the evaluation of trunk asymmetries of patients with scoliosis by physicians or therapists. TRACE is a scale that evaluates asymmetry in shoulders, scapula, waist and hemithorax in 4 items and gives a global score that can reflect the clinical change over time. It is scored between 0-2 points for shoulder asymmetry, hemithorax asymmetry, scapula asymmetry, and 0-4 points for waist asymmetry. The total score is obtained by adding 1 point to the total scores of the 4 items, and scoring varies between 1 and 12 points. High scores are associated with increased body asymmetry.
Baseline
Adams' Forward Bending Test
大体时间:Baseline
Adams' Forward Bending Test (FBT) is a clinical test that is frequently performed to reveal the suspicion of scoliosis in scoliosis screening. FBT shows the rib hump deformity caused by the vertebrae and ribs affected by scoliosis when the patient is in the forward bending position. It will recorded as positive or negative
Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Hurriyet Yilmaz, Prof、Halic University
  • 首席研究员:FİLİZ TUNA, Assoc Prof、Trakya University
  • 首席研究员:Aslıhan Kuşvuran Özkan, MD、Özel Özülkü Medical Center
  • 首席研究员:Sibel Özdoğan, MD、Yıldız Medstar Hospital
  • 首席研究员:Zeynep Turan, MD、Koc University
  • 首席研究员:Ahsen Büyükaslan, PT, MSc、Formed Scoliosis Brace and Treatment Center
  • 首席研究员:Hande Tunç, PT, MSc、Formed Scoliosis Brace and Treatment Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年11月23日

初级完成 (实际的)

2021年1月25日

研究完成 (预期的)

2021年5月1日

研究注册日期

首次提交

2021年5月2日

首先提交符合 QC 标准的

2021年5月4日

首次发布 (实际的)

2021年5月5日

研究记录更新

最后更新发布 (实际的)

2021年5月5日

上次提交的符合 QC 标准的更新

2021年5月4日

最后验证

2021年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • TÜTF-BAEK 2020/287

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

It was not planned to share individual participant data

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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