Adolescent Idiopathic ScoliosisNCT06083714
Effect of Scapular Stabilization Exercises in Individuals With Adolescent Idiopathic Scoliosis
A study testing Scapular Stabilization Exercises and Schroth Exercises in people with Adolescent Idiopathic Scoliosis, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Scapular Stabilization Exercises and Schroth Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2024to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with adolescent idiopathic scoliosis,
- Having Cobb angle between 10°-30°,
- Those with main thoracic curvature,
- Risser stage between 0-3,
- Volunteer individuals
Who cannot join
- Individuals who have had surgery related to the spine and upper extremity,
- Using a supra-axillary trunk orthosis,
- Having any systemic or neurological disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Lokman Hekim University
Ankara, Çankaya
Mustafa Sarı, 05395561937, mustafa.sari@lokmanhekim.edu.tr
About this study
Official title: 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Scapular Stabilization Exercises, Schroth Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapular Stabilization ExercisesOther
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 ExercisesOther
It will be implemented face to face, 3 days a week, each session lasting approximately 45 minutes and in 8-week programs.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants in this group will receive scapular stabilization exercises in addition to Schroth exercises specific to scoliosis. Receives: Other: Scapular Stabilization Exercises; Other: Schroth Exercises |
| Group 2 | Active comparator | Participants in this group will receive Schroth exercises specific to scoliosis only. Receives: Other: Schroth Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 8 weeks
Secondary outcomes (10)
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.
Measured: Change from baseline at 8 weeks
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.
Measured: Change from baseline at 8 weeks
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.
Measured: Change from baseline at 8 weeks
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.
Measured: Change from baseline at 8 weeks
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.
Measured: Change from baseline at 8 weeks
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.
Measured: Change from baseline at 8 weeks
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.
Measured: Change from baseline at 8 weeks
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
Measured: Change from baseline at 8 weeks
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.
Measured: Change from baseline at 8 weeks
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.
Measured: Change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start30 Mar 2024
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Sarı, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083714
- Sponsor's protocol ID
- 2023
- Status last verified
- May 2024
- First submitted
- 9 Oct 2023
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Scapular Stabilization Exercises on Scoliosis Severity, Scapula Position and Shoulder Imbalance in Individuals With Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06083714
- Acronym / sponsor ID
- 2023
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Scapular Stabilization Exercises, Other: Schroth ExercisesParticipants in this group will receive scapular stabilization exercises in addition to Schroth exercises specific to scoliosis. |
| Group 2 | Active comparator | Other: Schroth ExercisesParticipants in this group will receive Schroth exercises specific to scoliosis only. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosed with adolescent idiopathic scoliosis,
- Having Cobb angle between 10°-30°,
- Those with main thoracic curvature,
- Risser stage between 0-3,
- Volunteer individuals
Key exclusion criteria (3 listed)
- Individuals who have had surgery related to the spine and upper extremity,
- Using a supra-axillary trunk orthosis,
- Having any systemic or neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scapular Stabilization ExercisesHome-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. | Other | Group 1 |
| Schroth ExercisesIt will be implemented face to face, 3 days a week, each session lasting approximately 45 minutes and in 8-week programs. | Other | Group 1, Group 2 |
Primary outcome
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.
10 secondary outcomes
Axial Trunk Rotation
Time frame: Change from baseline at 8 weeks
Scapula Position-XRay
Time frame: Change from baseline at 8 weeks
Scapula Position-Lateral Scapula Slide Test
Time frame: Change from baseline at 8 weeks
Scapula Position-Scapular Index
Time frame: Change from baseline at 8 weeks
Periscapular Muscle Strength
Time frame: Change from baseline at 8 weeks
Shoulder Imbalance-Radiographic
Time frame: Change from baseline at 8 weeks
Shoulder Imbalance-Clinical
Time frame: Change from baseline at 8 weeks
Quality of Life Related to Scoliosis
Time frame: Change from baseline at 8 weeks
Cosmetic Deformity
Time frame: Change from baseline at 8 weeks
Satisfaction Level
Time frame: Change from baseline at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scapular Stabilization Exercises and Schroth Exercises in people with Adolescent Idiopathic Scoliosis, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoliosis Severity (time frame: Change from baseline at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.