Scoliosis Tele-Screening Test

NCT04873986 | Unknown

• 1 other identifier: TÜTF-BAEK 2020/287
• Study Type: observational
• Target: 865
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis; Posture Disorders in Children

Keywords

Scoliosis screening; Tele-medicine; virtual assessment; posture

Outcome Measures

Primary Outcomes (2)

• Accuracy of Scoliosis Tele-Screening Test

  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

  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

Secondary Outcomes (2)

• Trunk Aesthetic Clinical Evaluation score

  Baseline

• Adams' Forward Bending Test

  Baseline

Interventions

Scoliosis Tele-Screening Test DIAGNOSTIC_TEST

Scoliosis Tele-Screening test will be applied to children by parents at home. Participants with moderate and high risks will be invited to the physical examination to the centers or virtual assessment via 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.

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Schoolchildren age between 9-16 in Turkey.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Halic University

Istanbul, Beyoğlu/İstanbul, 34445, Turkey (Türkiye)

Location

Related Publications (7)

• Prowse A, Pope R, Gerdhem P, Abbott A. Reliability and validity of inexpensive and easily administered anthropometric clinical evaluation methods of postural asymmetry measurement in adolescent idiopathic scoliosis: a systematic review. Eur Spine J. 2016 Feb;25(2):450-66. doi: 10.1007/s00586-015-3961-7. Epub 2015 Apr 28.

  PMID: 25917824 BACKGROUND

• Zaina F, Negrini S, Atanasio S. TRACE (Trunk Aesthetic Clinical Evaluation), a routine clinical tool to evaluate aesthetics in scoliosis patients: development from the Aesthetic Index (AI) and repeatability. Scoliosis. 2009 Jan 20;4:3. doi: 10.1186/1748-7161-4-3.

  PMID: 19154604 BACKGROUND

• Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.

  PMID: 29435499 BACKGROUND

• Yilmaz H, Zateri C, Kusvuran Ozkan A, Kayalar G, Berk H. Prevalence of adolescent idiopathic scoliosis in Turkey: an epidemiological study. Spine J. 2020 Jun;20(6):947-955. doi: 10.1016/j.spinee.2020.01.008. Epub 2020 Jan 20.

  PMID: 31972303 BACKGROUND

• Negrini S, Grivas TB, Kotwicki T, Maruyama T, Rigo M, Weiss HR; Members of the Scientific society On Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT). Why do we treat adolescent idiopathic scoliosis? What we want to obtain and to avoid for our patients. SOSORT 2005 Consensus paper. Scoliosis. 2006 Apr 10;1:4. doi: 10.1186/1748-7161-1-4.

  PMID: 16759352 BACKGROUND

• Donaldson S, Stephens D, Howard A, Alman B, Narayanan U, Wright JG. Surgical decision making in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2007 Jun 15;32(14):1526-32. doi: 10.1097/BRS.0b013e318067dc75.

  PMID: 17572623 BACKGROUND

• Negrini S, Donzelli S, Di Felice F, Zaina F, Caronni A. Construct validity of the Trunk Aesthetic Clinical Evaluation (TRACE) in young people with idiopathic scoliosis. Ann Phys Rehabil Med. 2020 May;63(3):216-221. doi: 10.1016/j.rehab.2019.10.008. Epub 2019 Dec 6.

  PMID: 31816447 BACKGROUND

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Hurriyet Yilmaz, Prof

  Haliç University

  STUDY DIRECTOR

• FİLİZ TUNA, Assoc Prof

  Trakya University

  PRINCIPAL INVESTIGATOR

• Aslıhan Kuşvuran Özkan, MD

  Özel Özülkü Medical Center

  PRINCIPAL INVESTIGATOR

• Sibel Özdoğan, MD

  Yıldız Medstar Hospital

  PRINCIPAL INVESTIGATOR

• Zeynep Turan, MD

  Koç University

  PRINCIPAL INVESTIGATOR

• Ahsen Büyükaslan, PT, MSc

  Formed Scoliosis Brace and Treatment Center

  PRINCIPAL INVESTIGATOR

• Hande Tunç, PT, MSc

  Formed Scoliosis Brace and Treatment Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 5, 2021
• Study Start: November 23, 2020
• Primary Completion: January 25, 2021
• Study Completion: May 1, 2021
• Last Updated: May 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)