Pelvic Floor Muscle ActivationNCT07074873
Assessment of Pelvic Floor Muscle Activation in Adolescents With Idiopathic Scoliosis
An observational study of Pelvic Floor Muscle Activation and Idiopathic Scoliosis, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Adolescent idiopathic scoliosis is a three-dimensional deformity of the spine with a curvature of at least 10° on radiography, accompanied by rotation, seen in children aged 10-18 years, the cause of which is unknown. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Muscle Activation, Idiopathic Scoliosis
- What is being tested?
- Descriptive information form, Health-Related Quality of Life Assessment and Trunk rotation angle
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Sep 2024to 1 Aug 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult
Study population: Our study will include volunteers who have been diagnosed with adolescent idiopathic scoliosis at Istanbul Gaziosmanpaşa Training and Research Hospital and referred to the Spine Unit at Gaziosmanpaşa Physical Therapy Training and Research Hospital. Participants who volunteer to participate in the study will be selected based on the following inclusion and exclusion criteria. The control group of our study will include volunteers who underwent X-ray examinations for control purposes (presence of scoliosis in the family, postural abnormalities in appearance) at Istanbul Gaziosmanpaşa Training and Research Hospital and whose Cobb angles were below 10 degrees.
Who may be able to join
- Adolescents aged 10-18 diagnosed with adolescent idiopathic scoliosis (Study Group)
- Adolescents aged 10-18 not diagnosed with adolescent idiopathic scoliosis (Healthy partcipants) (Control Group)
- No neurological or psychiatric disorders (Study and Control Group)
- Parents and children must volunteer to participate in the study (Study and Control Group)
Who cannot join
- Having undergone surgery on the chest, abdomen or pelvic area
- Having undergone scoliosis surgery or being a candidate for surgery
- Having any mental health issues
- Having scoliosis that is not idiopathic but has arisen for other reasons (neurological, congenital, etc.)
- Having a diagnosis of urinary incontinence
- Being actively involved in sports
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Research and Education Hospital
Istanbul, Gaziosmanpasa, 34255
About this study
Adolescent idiopathic scoliosis is a three-dimensional deformity of the spine with a curvature of at least 10° on radiography, accompanied by rotation, seen in children aged 10-18 years, the cause of which is unknown. The pelvic floor consists of muscles and connective tissue in the shape of an equilateral triangle bounded by the symphysis pubis at the front, the sacrum at the back, and the ischial spines at the sides. The pelvic floor supports the pelvic organs, controls intra-abdominal pressure, maintains urinary and faecal control, and provides dynamic support to the body in conjunction with other core muscles. The aim of our study is to investigate pelvic floor muscle activation in adolescents with idiopathic scoliosis. Our study will include volunteers diagnosed with adolescent idiopathic scoliosis at Istanbul Gaziosmanpaşa Training and Research Hospital who have been referred to the Spine Unit of Gaziosmanpaşa Physical Therapy Training and Research Hospital for control purposes (presence of scoliosis in the family, postural abnormalities in appearance). X-rays will be taken, and volunteers with Cobb angles below 10 degrees will be included. Taking into account a 15% loss of the calculated sample, a total of 19 patients will be included in the study. The study group will consist of individuals diagnosed with adolescent idiopathic scoliosis, and the control group will consist of healthy individuals without spinal deformities. Each individual who agrees to participate in the study will undergo evaluations. For the study group, evaluations will include Cobb angle (radiography), trunk rotation angle (forward bending test), pelvic floor muscle activation (Neurotrac Myoplus 4 Pro) for both groups, and health-related quality of life (Paediatric Quality of Life Inventory).
Read the detailed description
Adolescent idiopathic scoliosis is a three-dimensional deformity of the spine with a curvature of at least 10° on radiography, accompanied by rotation, seen in children aged 10-18 years, the cause of which is unknown. The pelvic floor consists of muscles and connective tissue in the shape of an equilateral triangle bounded by the symphysis pubis at the front, the sacrum at the back, and the ischial spines at the sides. The pelvic floor supports the pelvic organs, controls intra-abdominal pressure, maintains urinary and faecal control, and provides dynamic support to the body in conjunction with other core muscles. The aim of our study is to investigate pelvic floor muscle activation in adolescents with idiopathic scoliosis.
Our study will include volunteers diagnosed with adolescent idiopathic scoliosis at Istanbul Gaziosmanpaşa Training and Research Hospital who have been referred to the Spine Unit of Gaziosmanpaşa Physical Therapy Training and Research Hospital for control purposes (presence of scoliosis in the family, postural abnormalities in appearance). X-rays will be taken, and volunteers with Cobb angles below 10 degrees will be included. Taking into account a 15% loss of the calculated sample, a total of 19 patients will be included in the study. The study group will consist of individuals diagnosed with adolescent idiopathic scoliosis, and the control group will consist of healthy individuals without spinal deformities. Each individual who agrees to participate in the study will undergo evaluations. For the study group, evaluations will include Cobb angle (radiography), trunk rotation angle (forward bending test), pelvic floor muscle activation (Neurotrac Myoplus 4 Pro) for both groups, and health-related quality of life (Paediatric Quality of Life Inventory).
Descriptive information form: The age, gender, height, weight, body mass index, age at menarche, time of initial diagnosis, how it was detected (medical history), family history (genealogy), dominant hand use, exercise habits (type of sport and duration), and corset use of individuals participating in the study will be recorded.
Health-Related Quality of Life Assessment: The Paediatric Quality of Life Inventory is a valid and reliable health-related quality of life questionnaire used for children. This inventory, which has been adapted into Turkish, consists of two forms for children and families. Both forms include sections on physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Scoring is done on a scale of 0-5 for each question (0 = Never causes a problem, 1 = Rarely causes a problem, 2 = Sometimes causes a problem, 3 = Often causes a problem, and 4 = Always causes a problem). The total score of the inventory ranges from 0 to 100 points (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0). A high score indicates better health-related quality of life. Since our study population is aged 10-18, the inventories developed for the 8-12 and 13-18 age groups will be used.
Trunk rotation angle: The Adam's Forward Bend Test is used as the primary assessment test in the clinical examination of scoliosis patients. In our study, the scoliometer assessment will be performed on the study group while the subjects are standing with equal weight on both feet. Patients will be asked to bend forward so that their shoulder level is aligned with their hip level (body parallel to the ground), and measurements will be taken with the scoliometer, with the highest degree recorded. The Baseline Scoliometer will be used for evaluations.
Cobb angle measurement: The Cobb angle allows for the evaluation of deformity in the frontal plane in scoliosis. It is obtained by measuring the lateral flexion angle of scoliosis from a standing spinal X-ray taken in the posterior-anterior direction. The angle between the perpendicular lines connecting the parallel line drawn from the upper edge of the uppermost vertebra (upper vertebra) involved in the curvature and the parallel line drawn from the lower edge of the lowest vertebra (lower vertebra) gives the Cobb angle . In our study, the Cobb angle will be recorded from the spinal X-ray.
Pelvic floor muscle activation measurement: Electromyographic measurement is the best-known non-invasive and practical method for measuring pelvic floor muscle activity (6). In our study, children's pelvic floor muscle activations will be assessed by a physiotherapist using the NeuroTrac Myoplus Pro4 device. The measurement will be performed in a room where no one else is present except the child and their parent. At the beginning, parents and the child will be informed about how the measurement will be performed. Before the measurement is taken, the child will be asked to completely empty their bladder. The physiotherapist will position the child in a supine position with the knees flexed at 140 degrees, the soles of the feet in contact with the bed, and the thighs and feet approximately 30 centimetres apart. Two surface electrodes will be placed at the 3 and 7 o'clock positions on the perineal region, and a 30×30 mm single-use electrode will be placed on the right thigh as a reference electrode. Children will be taught to contract the correct pelvic floor muscles to move in the ventral and cranial directions. The 'Work-Rest Assessment,' lasting a total of 55 seconds, will be applied to each child using the same device. First, children will be asked to relax their pelvic floor muscles. Then, 5 seconds of contraction (work) and 5 seconds of relaxation (rest) will be performed, and a total of 10 cycles of contraction and relaxation of the pelvic floor muscles will be requested. The device provides a report of the data in graphical and numerical form at the end of the measurement.
- Being tested
- Descriptive information form, Health-Related Quality of Life Assessment, Trunk rotation angle, Cobb angle measurement, Pelvic floor muscle activation measurement
- Keywords
- Pelvic Floor Muscle Activation, Adolescent Idiopathic Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descriptive information formOther
Also called Assessment Tool
The age, gender, height, weight, body mass index, age at menarche, time of initial diagnosis, how it was detected (medical history), family history (genealogy), dominant hand use, exercise habits (type of sport and duration), and corset use of individuals participating in the study will be recorded.
Health-Related Quality of Life AssessmentOther
Also called Paediatric Quality of Life Inventory
The Paediatric Quality of Life Inventory is a valid and reliable health-related quality of life questionnaire used for children. This inventory, which has been adapted into Turkish, consists of two forms for children and families. Both forms include sections on physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Scoring is done on a scale of 0-5 for each question (0 = Never causes a problem, 1 = Rarely causes a problem, 2 = Sometimes causes a problem, 3 = Often causes a problem, and 4 = Always causes a problem). The total score of the inventory ranges from 0 to 100 points (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0). A high score indicates better health-related quality of life. Since our study population is aged 10-18, the inventories developed for the 8-12 and 13-18 age groups will be used.
Trunk rotation angleDiagnostic test
The Adam's Forward Bend Test is used as the primary assessment test in the clinical examination of scoliosis patients. In our study, the scoliometer assessment will be performed on the study group while the subjects are standing with equal weight on both feet. Patients will be asked to bend forward so that their shoulder level is aligned with their hip level (body parallel to the ground), and measurements will be taken with the scoliometer, with the highest degree recorded. The Baseline Scoliometer will be used for evaluations.
Cobb angle measurementDiagnostic test
Also called Cobb method
The Cobb angle allows for the evaluation of deformity in the frontal plane in scoliosis. It is obtained by measuring the lateral flexion angle of scoliosis from a standing spinal X-ray taken in the posterior-anterior direction. The angle between the perpendicular lines connecting the parallel line drawn from the upper edge of the uppermost vertebra (upper vertebra) involved in the curvature and the parallel line drawn from the lower edge of the lowest vertebra (lower vertebra) gives the Cobb angle. In our study, the Cobb angle will be recorded from the spinal X-ray.
Pelvic floor muscle activation measurementDiagnostic test
The physiotherapist will position the child in a supine position with the knees flexed at 140 degrees, the soles of the feet in contact with the bed, and the thighs and feet approximately 30 centimetres apart. Two surface electrodes will be placed at the 3 and 7 o'clock positions on the perineal region, and a 30×30 mm single-use electrode will be placed on the right thigh as a reference electrode. Children will be taught to contract the correct pelvic floor muscles to move in the ventral and cranial directions. The 'Work-Rest Assessment,' lasting a total of 55 seconds, will be applied to each child using the same device. First, children will be asked to relax their pelvic floor muscles. Then, 5 seconds of contraction (work) and 5 seconds of relaxation (rest) will be performed, and a total of 10 cycles of contraction and relaxation of the pelvic floor muscles will be requested. The device provides a report of the data in graphical and numerical form at the end of the measurement.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with adolescent idiopathic scoliosis | Patients aged 10-18 years diagnosed with adolescent idiopathic scoliosis (Participants who have undergone X-rays for screening purposes (family history of scoliosis, postural abnormalities in appearance) at Istanbul Gaziosmanpaşa Training and Research Hospital and whose Cobb angles are above 10 degrees and will be included.) Receives: Other: Descriptive information form; Other: Health-Related Quality of Life Assessment; Diagnostic Test: Trunk rotation angle; Diagnostic Test: Cobb angle measurement; Diagnostic Test: Pelvic floor muscle activation measurement | |
| Healthy participants aged 10-18 with Cobb angle of less than 10 degrees | Participants who have undergone X-rays for screening purposes (family history of scoliosis, postural abnormalities in appearance) at Istanbul Gaziosmanpaşa Training and Research Hospital and whose Cobb angles are below 10 degrees will be included. Receives: Other: Descriptive information form; Other: Health-Related Quality of Life Assessment; Diagnostic Test: Trunk rotation angle; Diagnostic Test: Cobb angle measurement; Diagnostic Test: Pelvic floor muscle activation measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle activation measurement
Electromyographic measurement is the best-known non-invasive and practical method for measuring pelvic floor muscle activity. In our study, children's pelvic floor muscle activations will be assessed by a physiotherapist using the NeuroTrac Myoplus Pro4 device. Two surface electrodes will be placed at the 3 and 7 o'clock positions on the perineal region, and a 30×30 mm single-use electrode will be placed on the right thigh as a reference electrode. Children will be taught to contract the correct pelvic floor muscles to move in the ventral and cranial directions. The 'Work-Rest Assessment,' lasting a total of 55 seconds, will be applied to each child using the same device. First, children will be asked to relax their pelvic floor muscles. Then, 5 seconds of contraction (work) and 5 seconds of relaxation (rest) will be performed, and a total of 10 cycles of contraction and relaxation of the pelvic floor muscles will be requested. The device provides a report of the data in graphical.
Measured: Within one month of receiving a diagnosis and agreeing to volunteer
Secondary outcomes (1)
Health-Related Quality of Life Assessment
The Paediatric Quality of Life Inventory is a valid and reliable health-related quality of life questionnaire used for children. This inventory, which has been adapted into Turkish, consists of two forms for children and families. Both forms include sections on physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Scoring is done on a scale of 0-5 for each question (0 = Never causes a problem, 1 = Rarely causes a problem, 2 = Sometimes causes a problem, 3 = Often causes a problem, and 4 = Always causes a problem). The total score of the inventory ranges from 0 to 100 points (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0). A high score indicates better health-related quality of life (2). Since our study population is aged 10-18, the inventories developed for the 8-12 and 13-18 age groups will be used.
Measured: Within one month of receiving a diagnosis and agreeing to volunteer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start19 Sep 2024
- Primary completion1 Feb 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor Muscle ActivationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074873
- Sponsor's protocol ID
- 2024 - 1550
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hodges PW, Sapsford R, Pengel LH. Postural and respiratory functions of the pelvic floor muscles. Neurourol Urodyn. 2007;26(3):362-71. doi: 10.1002/nau.20232.
PubMed 17304528Sapsford R. Rehabilitation of pelvic floor muscles utilizing trunk stabilization. Man Ther. 2004 Feb;9(1):3-12. doi: 10.1016/s1356-689x(03)00131-0.
PubMed 14723856Koenig I, Luginbuehl H, Radlinger L. Reliability of pelvic floor muscle electromyography tested on healthy women and women with pelvic floor muscle dysfunction. Ann Phys Rehabil Med. 2017 Nov;60(6):382-386. doi: 10.1016/j.rehab.2017.04.002. Epub 2017 Jul 14.
PubMed 28716538
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pelvic Floor Muscle Activation in Adolescents With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT07074873
- Acronym / sponsor ID
- 2024 - 1550
- Keywords
- Pelvic Floor Muscle Activation, Adolescent Idiopathic Scoliosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 20 Jul 2025 (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.
Adolescent idiopathic scoliosis is a three-dimensional deformity of the spine with a curvature of at least 10° on radiography, accompanied by rotation, seen in children aged 10-18 years, the cause of which is unknown. The pelvic floor consists of muscles and connective tissue in the shape of an equilateral triangle bounded by the symphysis pubis at the front, the sacrum at the back, and the ischial spines at the sides. The pelvic floor supports the pelvic organs, controls intra-abdominal pressure, maintains urinary and faecal control, and provides dynamic support to the body in conjunction with other core muscles. The aim of our study is to investigate pelvic floor muscle activation in adolescents with idiopathic scoliosis. Our study will include volunteers diagnosed with adolescent idiopathic scoliosis at Istanbul Gaziosmanpaşa Training and Research Hospital who have been referred to the Spine Unit of Gaziosmanpaşa Physical Therapy Training and Research Hospital for control purposes (presence of scoliosis in the family, postural abnormalities in appearance). X-rays will be taken, and volunteers with Cobb angles below 10 degrees will be included. Taking into account a 15% loss of the calculated sample, a total of 19 patients will be included in the study. The study group will consist of individuals diagnosed with adolescent idiopathic scoliosis, and the control group will consist of healthy individuals without spinal deformities. Each individual who agrees to participate in the study will undergo evaluations. For the study group, evaluations will include Cobb angle (radiography), trunk rotation angle (forward bending test), pelvic floor muscle activation (Neurotrac Myoplus 4 Pro) for both groups, and health-related quality of life (Paediatric Quality of Life Inventory).
Detailed description
Adolescent idiopathic scoliosis is a three-dimensional deformity of the spine with a curvature of at least 10° on radiography, accompanied by rotation, seen in children aged 10-18 years, the cause of which is unknown. The pelvic floor consists of muscles and connective tissue in the shape of an equilateral triangle bounded by the symphysis pubis at the front, the sacrum at the back, and the ischial spines at the sides. The pelvic floor supports the pelvic organs, controls intra-abdominal pressure, maintains urinary and faecal control, and provides dynamic support to the body in conjunction with other core muscles. The aim of our study is to investigate pelvic floor muscle activation in adolescents with idiopathic scoliosis.
Our study will include volunteers diagnosed with adolescent idiopathic scoliosis at Istanbul Gaziosmanpaşa Training and Research Hospital who have been referred to the Spine Unit of Gaziosmanpaşa Physical Therapy Training and Research Hospital for control purposes (presence of scoliosis in the family, postural abnormalities in appearance). X-rays will be taken, and volunteers with Cobb angles below 10 degrees will be included. Taking into account a 15% loss of the calculated sample, a total of 19 patients will be included in the study. The study group will consist of individuals diagnosed with adolescent idiopathic scoliosis, and the control group will consist of healthy individuals without spinal deformities. Each individual who agrees to participate in the study will undergo evaluations. For the study group, evaluations will include Cobb angle (radiography), trunk rotation angle (forward bending test), pelvic floor muscle activation (Neurotrac Myoplus 4 Pro) for both groups, and health-related quality of life (Paediatric Quality of Life Inventory).
Descriptive information form: The age, gender, height, weight, body mass index, age at menarche, time of initial diagnosis, how it was detected (medical history), family history (genealogy), dominant hand use, exercise habits (type of sport and duration), and corset use of individuals participating in the study will be recorded.
Health-Related Quality of Life Assessment: The Paediatric Quality of Life Inventory is a valid and reliable health-related quality of life questionnaire used for children. This inventory, which has been adapted into Turkish, consists of two forms for children and families. Both forms include sections on physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Scoring is done on a scale of 0-5 for each question (0 = Never causes a problem, 1 = Rarely causes a problem, 2 = Sometimes causes a problem, 3 = Often causes a problem, and 4 = Always causes a problem). The total score of the inventory ranges from 0 to 100 points (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0). A high score indicates better health-related quality of life. Since our study population is aged 10-18, the inventories developed for the 8-12 and 13-18 age groups will be used.
Trunk rotation angle: The Adam's Forward Bend Test is used as the primary assessment test in the clinical examination of scoliosis patients. In our study, the scoliometer assessment will be performed on the study group while the subjects are standing with equal weight on both feet. Patients will be asked to bend forward so that their shoulder level is aligned with their hip level (body parallel to the ground), and measurements will be taken with the scoliometer, with the highest degree recorded. The Baseline Scoliometer will be used for evaluations.
Cobb angle measurement: The Cobb angle allows for the evaluation of deformity in the frontal plane in scoliosis. It is obtained by measuring the lateral flexion angle of scoliosis from a standing spinal X-ray taken in the posterior-anterior direction. The angle between the perpendicular lines connecting the parallel line drawn from the upper edge of the uppermost vertebra (upper vertebra) involved in the curvature and the parallel line drawn from the lower edge of the lowest vertebra (lower vertebra) gives the Cobb angle . In our study, the Cobb angle will be recorded from the spinal X-ray.
Pelvic floor muscle activation measurement: Electromyographic measurement is the best-known non-invasive and practical method for measuring pelvic floor muscle activity (6). In our study, children's pelvic floor muscle activations will be assessed by a physiotherapist using the NeuroTrac Myoplus Pro4 device. The measurement will be performed in a room where no one else is present except the child and their parent. At the beginning, parents and the child will be informed about how the measurement will be performed. Before the measurement is taken, the child will be asked to completely empty their bladder. The physiotherapist will position the child in a supine position with the knees flexed at 140 degrees, the soles of the feet in contact with the bed, and the thighs and feet approximately 30 centimetres apart. Two surface electrodes will be placed at the 3 and 7 o'clock positions on the perineal region, and a 30×30 mm single-use electrode will be placed on the right thigh as a reference electrode. Children will be taught to contract the correct pelvic floor muscles to move in the ventral and cranial directions. The 'Work-Rest Assessment,' lasting a total of 55 seconds, will be applied to each child using the same device. First, children will be asked to relax their pelvic floor muscles. Then, 5 seconds of contraction (work) and 5 seconds of relaxation (rest) will be performed, and a total of 10 cycles of contraction and relaxation of the pelvic floor muscles will be requested. The device provides a report of the data in graphical and numerical form at the end of the measurement.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with adolescent idiopathic scoliosis | – | Other: Descriptive information form, Other: Health-Related Quality of Life Assessment, Diagnostic Test: Trunk rotation angle, Diagnostic Test: Cobb angle measurement, Diagnostic Test: Pelvic floor muscle activation measurementPatients aged 10-18 years diagnosed with adolescent idiopathic scoliosis (Participants who have undergone X-rays for screening purposes (family history of scoliosis, postural abnormalities in appearance) at Istanbul Gaziosmanpaşa Training and Research Hospital and whose Cobb angles are above 10 degrees and will be included.) |
| Healthy participants aged 10-18 with Cobb angle of less than 10 degrees | – | Other: Descriptive information form, Other: Health-Related Quality of Life Assessment, Diagnostic Test: Trunk rotation angle, Diagnostic Test: Cobb angle measurement, Diagnostic Test: Pelvic floor muscle activation measurementParticipants who have undergone X-rays for screening purposes (family history of scoliosis, postural abnormalities in appearance) at Istanbul Gaziosmanpaşa Training and Research Hospital and whose Cobb angles are below 10 degrees will be included. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Our study will include volunteers who have been diagnosed with adolescent idiopathic scoliosis at Istanbul Gaziosmanpaşa Training and Research Hospital and referred to the Spine Unit at Gaziosmanpaşa Physical Therapy Training and Research Hospital. Participants who volunteer to participate in the study will be selected based on the following inclusion and exclusion criteria. The control group of our study will include volunteers who underwent X-ray examinations for control purposes (presence of scoliosis in the family, postural abnormalities in appearance) at Istanbul Gaziosmanpaşa Training and Research Hospital and whose Cobb angles were below 10 degrees.
Key inclusion criteria (4 listed)
- Adolescents aged 10-18 diagnosed with adolescent idiopathic scoliosis (Study Group)
- Adolescents aged 10-18 not diagnosed with adolescent idiopathic scoliosis (Healthy partcipants) (Control Group)
- No neurological or psychiatric disorders (Study and Control Group)
- Parents and children must volunteer to participate in the study (Study and Control Group)
Key exclusion criteria (6 listed)
- Having undergone surgery on the chest, abdomen or pelvic area
- Having undergone scoliosis surgery or being a candidate for surgery
- Having any mental health issues
- Having scoliosis that is not idiopathic but has arisen for other reasons (neurological, congenital, etc.)
- Having a diagnosis of urinary incontinence
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 |
|---|---|---|
| Descriptive information formAlso: Assessment ToolThe age, gender, height, weight, body mass index, age at menarche, time of initial diagnosis, how it was detected (medical history), family history (genealogy), dominant hand use, exercise habits (type of sport and duration), and corset use of individuals participating in the study will be recorded. | Other | Healthy participants aged 10-18 with Cobb angle of less than 10 degrees, Patients diagnosed with adolescent idiopathic scoliosis |
| Health-Related Quality of Life AssessmentAlso: Paediatric Quality of Life InventoryThe Paediatric Quality of Life Inventory is a valid and reliable health-related quality of life questionnaire used for children. This inventory, which has been adapted into Turkish, consists of two forms for children and families. Both forms include sections on physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Scoring is done on a scale of 0-5 for each question (0 = Never causes a problem, 1 = Rarely causes a problem, 2 = Sometimes causes a problem, 3 = Often causes a problem, and 4 = Always causes a problem). The total score of the inventory ranges from 0 to 100 points (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0). A high score indicates better health-related quality of life. Since our study population is aged 10-18, the inventories developed for the 8-12 and 13-18 age groups will be used. | Other | Healthy participants aged 10-18 with Cobb angle of less than 10 degrees, Patients diagnosed with adolescent idiopathic scoliosis |
| Trunk rotation angleThe Adam's Forward Bend Test is used as the primary assessment test in the clinical examination of scoliosis patients. In our study, the scoliometer assessment will be performed on the study group while the subjects are standing with equal weight on both feet. Patients will be asked to bend forward so that their shoulder level is aligned with their hip level (body parallel to the ground), and measurements will be taken with the scoliometer, with the highest degree recorded. The Baseline Scoliometer will be used for evaluations. | Diagnostic test | Healthy participants aged 10-18 with Cobb angle of less than 10 degrees, Patients diagnosed with adolescent idiopathic scoliosis |
| Cobb angle measurementAlso: Cobb methodThe Cobb angle allows for the evaluation of deformity in the frontal plane in scoliosis. It is obtained by measuring the lateral flexion angle of scoliosis from a standing spinal X-ray taken in the posterior-anterior direction. The angle between the perpendicular lines connecting the parallel line drawn from the upper edge of the uppermost vertebra (upper vertebra) involved in the curvature and the parallel line drawn from the lower edge of the lowest vertebra (lower vertebra) gives the Cobb angle. In our study, the Cobb angle will be recorded from the spinal X-ray. | Diagnostic test | Healthy participants aged 10-18 with Cobb angle of less than 10 degrees, Patients diagnosed with adolescent idiopathic scoliosis |
| Pelvic floor muscle activation measurementThe physiotherapist will position the child in a supine position with the knees flexed at 140 degrees, the soles of the feet in contact with the bed, and the thighs and feet approximately 30 centimetres apart. Two surface electrodes will be placed at the 3 and 7 o'clock positions on the perineal region, and a 30×30 mm single-use electrode will be placed on the right thigh as a reference electrode. Children will be taught to contract the correct pelvic floor muscles to move in the ventral and cranial directions. The 'Work-Rest Assessment,' lasting a total of 55 seconds, will be applied to each child using the same device. First, children will be asked to relax their pelvic floor muscles. Then, 5 seconds of contraction (work) and 5 seconds of relaxation (rest) will be performed, and a total of 10 cycles of contraction and relaxation of the pelvic floor muscles will be requested. The device provides a report of the data in graphical and numerical form at the end of the measurement. | Diagnostic test | Healthy participants aged 10-18 with Cobb angle of less than 10 degrees, Patients diagnosed with adolescent idiopathic scoliosis |
Primary outcome
Pelvic floor muscle activation measurement
Time frame: Within one month of receiving a diagnosis and agreeing to volunteer
Electromyographic measurement is the best-known non-invasive and practical method for measuring pelvic floor muscle activity. In our study, children's pelvic floor muscle activations will be assessed by a physiotherapist using the NeuroTrac Myoplus Pro4 device. Two surface electrodes will be placed at the 3 and 7 o'clock positions on the perineal region, and a 30×30 mm single-use electrode will be placed on the right thigh as a reference electrode. Children will be taught to contract the correct pelvic floor muscles to move in the ventral and cranial directions. The 'Work-Rest Assessment,' lasting a total of 55 seconds, will be applied to each child using the same device. First, children will be asked to relax their pelvic floor muscles. Then, 5 seconds of contraction (work) and 5 seconds of relaxation (rest) will be performed, and a total of 10 cycles of contraction and relaxation of the pelvic floor muscles will be requested. The device provides a report of the data in graphical.
1 secondary outcome
Health-Related Quality of Life Assessment
Time frame: Within one month of receiving a diagnosis and agreeing to volunteer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 17304528Hodges PW, Sapsford R, Pengel LH. Postural and respiratory functions of the pelvic floor muscles. Neurourol Urodyn. 2007;26(3):362-71. doi: 10.1002/nau.20232.
- Background: PubMed 14723856Sapsford R. Rehabilitation of pelvic floor muscles utilizing trunk stabilization. Man Ther. 2004 Feb;9(1):3-12. doi: 10.1016/s1356-689x(03)00131-0.
- Background: PubMed 28716538Koenig I, Luginbuehl H, Radlinger L. Reliability of pelvic floor muscle electromyography tested on healthy women and women with pelvic floor muscle dysfunction. Ann Phys Rehabil Med. 2017 Nov;60(6):382-386. doi: 10.1016/j.rehab.2017.04.002. Epub 2017 Jul 14.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Muscle Activation and Idiopathic Scoliosis, run by Gaziosmanpasa Research and Education Hospital 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 10 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor muscle activation measurement (time frame: Within one month of receiving a diagnosis and agreeing to volunteer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07074873, which also lists 3 linked publications.
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 10 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.