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Completed

NCT Number: NCT07074873

Assessment of Pelvic Floor Muscle Activation in Adolescents With Idiopathic Scoliosis

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).

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaziosmanpasa Research and Education Hospital

Istanbul, Gaziosmanpasa, 34255, Turkey (Türkiye)

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).

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

For both Study and Control Group

  • 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

Treatment and study plan

Descriptive information form

Other

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.

Other names: Assessment Tool

Health-related quality of life assessment

Other

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.

Other names: Paediatric Quality of Life Inventory

Trunk rotation angle

Diagnostic 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 measurement

Diagnostic Test

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.

Other names: Cobb method

Pelvic floor muscle activation measurement

Diagnostic 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Health-Related Quality of Life Assessment

    Time frame: Within one month of receiving a diagnosis and agreeing to volunteer

    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.

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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