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Scoliosis Tele-Screening Test

4 de maio de 2021 atualizado por: 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.

Visão geral do estudo

Status

Ativo, não recrutando

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

865

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Beyoğlu/İstanbul
      • Istanbul, Beyoğlu/İstanbul, Peru, 34445
        • Halic University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

9 anos a 16 anos (Filho)

Aceita Voluntários Saudáveis

N/D

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Schoolchildren age between 9-16 in Turkey.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Accuracy of Scoliosis Tele-Screening Test
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Trunk Aesthetic Clinical Evaluation score
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Diretor de estudo: Hurriyet Yilmaz, Prof, Halic University
  • Investigador principal: FİLİZ TUNA, Assoc Prof, Trakya University
  • Investigador principal: Aslıhan Kuşvuran Özkan, MD, Özel Özülkü Medical Center
  • Investigador principal: Sibel Özdoğan, MD, Yıldız Medstar Hospital
  • Investigador principal: Zeynep Turan, MD, Koc University
  • Investigador principal: Ahsen Büyükaslan, PT, MSc, Formed Scoliosis Brace and Treatment Center
  • Investigador principal: Hande Tunç, PT, MSc, Formed Scoliosis Brace and Treatment Center

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

23 de novembro de 2020

Conclusão Primária (Real)

25 de janeiro de 2021

Conclusão do estudo (Antecipado)

1 de maio de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

2 de maio de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de maio de 2021

Primeira postagem (Real)

5 de maio de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de maio de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de maio de 2021

Última verificação

1 de maio de 2021

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • TÜTF-BAEK 2020/287

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

It was not planned to share individual participant data

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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