- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06083714
Effect of Scapular Stabilization Exercises in Individuals With Adolescent Idiopathic Scoliosis
May 12, 2024 updated by: Mustafa Sarı, Lokman Hekim Üniversitesi
Effect of Scapular Stabilization Exercises on Scoliosis Severity, Scapula Position and Shoulder Imbalance in Individuals With Adolescent Idiopathic Scoliosis
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Çankaya
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Ankara, Çankaya, Turkey
- Recruiting
- Lokman Hekim University
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Contact:
- Mustafa Sarı
- Phone Number: 05395561937
- Email: mustafa.sari@lokmanhekim.edu.tr
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Participants in this group will receive scapular stabilization exercises in addition to Schroth exercises specific to scoliosis.
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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.
It will be implemented face to face, 3 days a week, each session lasting approximately 45 minutes and in 8-week programs.
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Active Comparator: Group 2
Participants in this group will receive Schroth exercises specific to scoliosis only.
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It will be implemented face to face, 3 days a week, each session lasting approximately 45 minutes and in 8-week programs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scoliosis Severity
Time Frame: Change from baseline at 8 weeks
|
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.
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Change from baseline at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Axial Trunk Rotation
Time Frame: Change from baseline at 8 weeks
|
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
|
|
Scapula Position-XRay
Time Frame: Change from baseline at 8 weeks
|
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.
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Change from baseline at 8 weeks
|
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Scapula Position-Lateral Scapula Slide Test
Time Frame: Change from baseline at 8 weeks
|
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.
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Change from baseline at 8 weeks
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Scapula Position-Scapular Index
Time Frame: Change from baseline at 8 weeks
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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.
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Change from baseline at 8 weeks
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Periscapular Muscle Strength
Time Frame: Change from baseline at 8 weeks
|
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.
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Change from baseline at 8 weeks
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Shoulder Imbalance-Radiographic
Time Frame: Change from baseline at 8 weeks
|
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.
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Change from baseline at 8 weeks
|
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Shoulder Imbalance-Clinical
Time Frame: Change from baseline at 8 weeks
|
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
|
|
Quality of Life Related to Scoliosis
Time Frame: Change from baseline at 8 weeks
|
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
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Change from baseline at 8 weeks
|
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Cosmetic Deformity
Time Frame: Change from baseline at 8 weeks
|
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.
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Change from baseline at 8 weeks
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Satisfaction Level
Time Frame: Change from baseline at 8 weeks
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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.
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Change from baseline at 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 30, 2024
Primary Completion (Estimated)
August 30, 2024
Study Completion (Estimated)
October 30, 2024
Study Registration Dates
First Submitted
October 9, 2023
First Submitted That Met QC Criteria
October 9, 2023
First Posted (Actual)
October 16, 2023
Study Record Updates
Last Update Posted (Actual)
May 14, 2024
Last Update Submitted That Met QC Criteria
May 12, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023 (GRAMMY Museum Foundation)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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