Clinical trial NCT04873986: Scoliosis Tele-Screening Test
Official title: A New Clinical Tool for Scoliosis Risk Analysis: Scoliosis Tele-Screening Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scoliosis
Posture Disorders in Children
Keywords: Scoliosis screening
Tele-medicine
virtual assessment
posture
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 865
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Schoolchildren age between 9-16 in Turkey.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of Scoliosis Tele-Screening Test
timeFrame: through study completion, an average of 1 year
measure: To investigate the consistency between researchers' assessment and the results of the Scoliosis Tele-Screening Test by the parents for the same case
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Trunk Aesthetic Clinical Evaluation score
timeFrame: Baseline
measure: Adams' Forward Bending Test
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Halic University
state: Beyoğlu/İstanbul
Study officials:
affiliation: Haliç University
name: Hurriyet Yilmaz, Prof
role: STUDY_DIRECTOR
affiliation: Trakya University
name: FİLİZ TUNA, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Özel Özülkü Medical Center
name: Aslıhan Kuşvuran Özkan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yıldız Medstar Hospital
name: Sibel Özdoğan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Koç University
name: Zeynep Turan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Formed Scoliosis Brace and Treatment Center
name: Ahsen Büyükaslan, PT, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Formed Scoliosis Brace and Treatment Center
name: Hande Tunç, PT, MSc
role: PRINCIPAL_INVESTIGATOR
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