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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04203394
Other study ID # 02.04.2018 2018/57-06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 18, 2019
Est. completion date May 30, 2021

Study information

Verified date October 2022
Source Eastern Mediterranean University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the effects of Schroth 3D exercise method on home symmetry, trunk topography, scapula symmetry, pelvic symmetry, health related quality of life and cosmetic deformity perception in adolescents with idiopathic scoliosis


Description:

Cobb angle measurement, which is accepted as the gold standard in patients with scoliosis, is a radiological measurement. However, in continuous follow-up, the search for other methods to obtain objective data that will provide a short term evaluation on the patient in determining the efficacy of conservative treatment continues. In our study, individuals who meet the criteria will be evaluated at the beginning and end of the study. Sociodemographic features and scoliosis characteristics (Cobb angle, degree of bone maturation according to Risser, apex, vertebra rotation angle) will be recorded. Posterior Trunk Asymmetry Index (POTSI) will be used to determine body asymmetry, and topographic measurements will be performed with Artec Eva 3D Scanner and motion analysis will be performed with Biomechanical Motion Analysis Sistem (Model is BTS Smart DX100) . Individuals will evaluate their cosmetic deformities with the Walter Reed Visual Evaluation Scale. Scoliosis Research Society-22 will be used to measure quality of life.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date May 30, 2021
Est. primary completion date January 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 16 Years
Eligibility Inclusion Criteria: - Patients with scoliosis diagnosed and followed up by the attending physician - 10-16 age group, - Patients who voluntarily agreed to participate in the study - Living in Antalya/TURKEY Exclusion Criteria: - Mental retardation, congenital scoliosis or spinal deformity, spinal surgery, neuromuscular disease, rheumatologic disease, tumor, cardiovascular or pulmonary disease, vertigo attack or balance problem, neurological disease - Individual who does not sign the consent form

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Schroth Exercise Group
12 week , Exercises 1 hour, 2 times for a week with physiotherapist 20 minutes home exercise
Home Exercise Group
Home exercise 20 min at home Once, one hour to determine the Schroth program + teaching home exercises 20 minutes home exercise

Locations

Country Name City State
Turkey Akdeniz University Physical Therapy and Rehabilitation Antalya Konyaalti

Sponsors (2)

Lead Sponsor Collaborator
Eastern Mediterranean University Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Root Mean Square(RMS) Body right and left asymmetry will be examined. 12 weeks
Primary 3D Motion analysis 3D motion analysis with 4 cameras, symmetry of certain points will be evaluated during motion. 12 weeks
Primary Postural Trunk Asymmetry Index (POTSI) It is a method that allows an individual with AIS to evaluate body shape and asymmetry. 12 weeks
Primary Walter Reed Visuel Assesment Scale Walter Reed Visuel Assesment Scale (WRVAS) each aspect is shown with five levels of increasing severity of the seven type of deformity that are scored from minimum (1) to maximum (5). How individuals perceive their own cosmetic deformities and the effectiveness of treatment in improving cosmetic deformity can be evaluated 12 weeks
Primary Scoliosis Research Society-22 Scoliosis Research Society (SRS-22) is a simple and practical questionnaire specific to individuals with scoliosis. The questionnaire included pain, self-image, function / activity, mental health and treatment satisfaction. There are 22 questionnaire questions, scoring from 1 to 5. The minimum score is the worst score (22). 12 weeks
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