Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04873986
Status:
UNKNOWN
Last Update Posted:
2021-05-05
First Post:
2021-05-02
Brief Title:
Scoliosis Tele-Screening Test
Sponsor:
Trakya University
Organization:
Trakya University
Study Overview
Official Title:
A New Clinical Tool for Scoliosis Risk Analysis Scoliosis Tele-Screening Test
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 31 in females and 15 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 knowledgeawareness level regarding scoliosis 3 questions on the risk factors related to scoliosis development 7 questions about the cosmetic deformities that scoliosis may causecan reveal and 5 questions the satisfaction of the parentevaluator 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 parentevaluator 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
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 knowledgeawareness level regarding scoliosis 3 questions on the risk factors related to scoliosis development 7 questions about the cosmetic deformities that scoliosis may causecan reveal and 5 questions the satisfaction of the parentevaluator 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 parentevaluator 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None