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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06083714
Other study ID # 2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 30, 2024
Est. completion date October 30, 2024

Study information

Verified date May 2024
Source Lokman Hekim Üniversitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Idiopathic scoliosis is a three-dimensional deformity of the spine that accounts for approximately 70% of all scoliosis anomalies, and adolescent idiopathic scoliosis (AIS) is the most common type. AIS not only changes the shape of the trunk, but also the relationships between body parts. Considering the close anatomical relationship between the scapula and the rib cage, AIS is associated with changes in scapular position and orientation. Scapular stabilization exercises; these are exercises that aim to restore the position and orientation of the scapula and the motor control and movement pattern of the muscles, thus providing scapula stability for better shoulder kinematics. There are studies reporting that scapular stabilization exercises should be included in the rehabilitation program of patients with scapular dyskinesia and various shoulder pathologies. However, no study has been found in the literature examining the effects of scapular stabilization exercises on changes in scapular position, shoulder imbalance and curve severity seen in scoliosis. Therefore, the aim of the study is to investigate the effect of scapular stabilization exercises applied in addition to Schroth exercises used in the treatment of individuals with AIS, on scoliosis severity, scapula position and shoulder imbalance.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender All
Age group 10 Years to 18 Years
Eligibility Inclusion Criteria: - Diagnosed with adolescent idiopathic scoliosis, - Having Cobb angle between 10°-30°, - Those with main thoracic curvature, - Risser stage between 0-3, - Volunteer individuals Exclusion Criteria: - Individuals who have had surgery related to the spine and upper extremity, - Using a supra-axillary trunk orthosis, - Having any systemic or neurological disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Scapular Stabilization Exercises
Home-based scapular stabilization exercises (Inferior Glide, Low Row, Scapular Clock, Wall Push Up, Wall Slide and Squat Robbery) will be performed once or twice a day, 3 sets x 20 repetitions, 3 days a week for 8 weeks.
Schroth Exercises
It will be implemented face to face, 3 days a week, each session lasting approximately 45 minutes and in 8-week programs.

Locations

Country Name City State
Turkey Lokman Hekim University Ankara Çankaya

Sponsors (1)

Lead Sponsor Collaborator
Lokman Hekim Üniversitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Scoliosis Severity In determining the degree of curvature, the Cobb angle obtained from the spine x-ray taken in the antero-posterior direction and containing the entire spine will be accepted as the standard measurement method. End vertebral levels will be recorded on the antero-posterior x-ray. Lines perpendicular to the upper end plate of the upper end vertebra and the lower end plate of the lower end vertebra will be drawn and the angle formed between these lines will be recorded as the Cobb angle. Change from baseline at 8 weeks
Secondary Axial Trunk Rotation Individuals' trunk rotation angles will be measured with the Adam's Forward Bend Test, which is considered the most practical scoliosis evaluation method in the clinic. Change from baseline at 8 weeks
Secondary Scapula Position-XRay Radiography measurements will be taken in the anterio-posterior direction by the same technician. Scapular position will be measured by drawing a vertical axis line connecting two points on the centerline of the sternal body. The vertical distance to the vertical axis line will be calculated separately at the superior border, at the midpoint of the vertebral border, and at the inferior border of the scapula. Change from baseline at 8 weeks
Secondary Scapula Position-Lateral Scapula Slide Test It is a quantitative method developed by Kibler and used to define scapular symmetry by measuring the distance between the distal end of the scapula and the spinous process of the aligned vertebra in three different arm positions. Patients will be asked to stand steadily on a hard, flat surface. Measurements; It will be performed in 3 different positions: arms next to the body, hands on the waist, arms raised to the sides at shoulder level, and the thumb pointing to the ground. A difference of more than 1.5 cm between two edges will be considered asymmetric. Change from baseline at 8 weeks
Secondary Scapula Position-Scapular Index It is obtained by measuring the distance from the sternal notch (SN) to the coracoid process (CP) and the horizontal distance from the posterolateral angle (PLA) of the acromion to the corresponding thoracic spine (TS) with a tape measure. As the final score; The formula [(distance between SN-CP / distance between PLA-TS) X 100] is used. A lower scapular index score indicates an increase in scapula internal rotation. Change from baseline at 8 weeks
Secondary Periscapular Muscle Strength Isometric strength testing of the upper trapezius, middle trapezius, lower trapezius and serratus anterior muscles will be performed using a hand dynamometer as described by Kendall. Change from baseline at 8 weeks
Secondary Shoulder Imbalance-Radiographic For radiographic evaluation of shoulder imbalance; coracoid height difference, clavicular angle, clavicle-rib intersection difference, radiographic shoulder height, T1 tilt, first rib angle and neck tilt measurements will be used. Change from baseline at 8 weeks
Secondary Shoulder Imbalance-Clinical For clinical evaluation of shoulder imbalance; shoulder level angle, anterior/posterior axillary angle, scapular angle, shoulder height difference, trapezial and clavicular angle and trapezial area measurements will be used. Change from baseline at 8 weeks
Secondary Quality of Life Related to Scoliosis It will be evaluated using the Japanese Scoliosis Questionnaire-27, which was developed by Doi et al. and its validity and reliability in Turkish was made by Bazancir et al. Ratings are on a 5-point Likert-type scale from 0 = "not at all" to 4 = "quite a bit", and the total score ranges from 0 to 108 points. A lower score indicates a better quality of life Change from baseline at 8 weeks
Secondary Cosmetic Deformity The Walter Reed Visual Assessment Scale (WRVAS) is a scale consisting entirely of visual figures developed to help individuals with idiopathic scoliosis describe how they perceive their deformity. The WRVAS scale consists of 7 items that evaluate spinal deformity, costal protrusion, lumbar protrusion, thoracic deformity, trunk imbalance, shoulder asymmetry and scapular asymmetry, and include 5 different figures representing severity, showing different aspects of spinal deformity. The figures in each item are scored between 1 and 5 points according to the severity of deformity (1: no deformity, 5: severe deformity). The person marks the figure that suits his/her body in each item of the scale. The scale allows scoring of curve severity by focusing on the person's perception of posture. Change from baseline at 8 weeks
Secondary Satisfaction Level Individuals' satisfaction levels with scapula and spine position and shoulder symmetry will be evaluated with a survey created by the researchers in the light of current literature. Change from baseline at 8 weeks
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