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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05056363
Other study ID # IUFGokdemir01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 5, 2021
Est. completion date March 25, 2022

Study information

Verified date February 2024
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Adolescent idiopathic scoliosis (AIS) is a three-dimensional structural deformity of the spine in which lateral flexion and axial rotation are seen in vertebrae with a Cobb (method for measuring spinal curvature) angle of 10° and above. AIS is the most common type of scoliosis and it occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates. Children with AIS have cosmetic effects, decrease in functional capacity, muscle weakness in certain parts of the body, decrease in quality of life and posture disorders. Lack of core stability might be causing these problems. Core stability training may have a positive effect for these problems experienced by children with AIS. Pathologies that cause the disease may originate from the nervous system and musculoskeletal system. In this study, the investigators will evaluate these systems objectively with EMG biofeedback and Isokinetic Testing. The aim of this study is to show the effect of core stability training on various problems (as we mentioned before) caused by the disease. In addition, the investigators of this study hope to contribute to the literature(with objective evaluations) about the pathological background and treatment of this challenging disease which the cause is unknown.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date March 25, 2022
Est. primary completion date March 10, 2022
Accepts healthy volunteers No
Gender All
Age group 10 Years to 20 Years
Eligibility Inclusion Criteria: - Diagnosed with AIS between the ages of 10-20 - Cobb angle is between 15-40 degrees - The child's and family's consent to participate in the study - The child does not receive any other treatment that will affect his scoliosis. Exclusion Criteria: - Surgical operation in the last 3 months - Presence of an orthopedic, neurological, systemic disease that will prevent him from exercising - Having mental, communicative and behavioral disorders that may cause problems understanding commands and questions or performing exercises - Exercising 3 or more days a week.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Home Based Traditional Scoliosis Exercises
Patients in this group will receive posture exercises, strengthening exercises, diaphragmatic breathing exercises and stretching exercises.
Core Stability Training
Patients in this group will receive traditional scoliosis exercises. In addition, the training group will receive core stabilization exercises for multifidus, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, iliopsoas, gluteus maximus, and pelvic floor muscles.

Locations

Country Name City State
Turkey Istanbul University Istanbul Fatih

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Strength of Trunk Flexion / Extension Measurement of isokinetic and isometric muscle strength with Biodex System 3Pro Multijoint System Isokinetic Dynamometer. 8 week
Primary Cobb Angle Cobb Angle measurement with AP Radiography 8 week
Primary Muscle Strength Evaluation of the muscle strength with using a non-invasive Myomed 932 EMG-biofeedback device (Enraf-Nonius, The Netherlands) 8 week
Primary Muscle Electromyographic Activity Measurement of the surface electromyographic activity with using a non-invasive Myomed 932 EMG-biofeedback device (Enraf-Nonius, The Netherlands) 8 week
Secondary Trunk Rotation Evaluation of the thoracic, thoracic-lumber junction, lumber axial trunk rotation with Bunnell Scoliometer 8 week
Secondary Patients Quality of Life Quality of life will be measured with using the Scoliosis Research Society 22 item questionnaire (SRS-22r).
SRS-22 has a minimum score of 22 and a maximum score of 110. Each question is scored on 1-5 scale. Questions are sorted into different domains and total and mean scores for each domain are calculated. A total score for the entire questionnaire is also calculated.
8 week
Secondary Cosmetic Deformity Evaluation Patients cosmetic deformity will be evaluated with Walter Reed Visuel Assesment Scale.
This scale includes seven items with figures representing different aspects of the spinal deformity: spinal deformity, rib prominence, lumbar prominence, thoracic deformity, trunk imbalance, shoulder asymmetry and scapular asymmetry. The figures are scored from minimum (1, no deformity) to maximum (5, severe deformity) and summed up to yield a total score (minimum: 5 points, maximum: 35 points).
8 week
Secondary Flexibility Measurement Patients flexibility will be measured with forward and lateral bending tests 8 week
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