NCT07074873

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 19, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

February 10, 2026

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

July 10, 2025

Last Update Submit

February 8, 2026

Conditions

Keywords

Pelvic Floor Muscle ActivationAdolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within one month of receiving a diagnosis and agreeing to volunteer

Secondary Outcomes (1)

  • Health-Related Quality of Life Assessment

    Within one month of receiving a diagnosis and agreeing to volunteer

Study Arms (2)

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.)

Other: Descriptive information formOther: Health-Related Quality of Life AssessmentDiagnostic Test: Trunk rotation angleDiagnostic Test: Cobb angle measurementDiagnostic 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.

Other: Descriptive information formOther: Health-Related Quality of Life AssessmentDiagnostic Test: Trunk rotation angleDiagnostic Test: Cobb angle measurementDiagnostic Test: Pelvic floor muscle activation measurement

Interventions

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.

Also known as: Paediatric Quality of Life Inventory
Healthy participants aged 10-18 with Cobb angle of less than 10 degreesPatients diagnosed with adolescent idiopathic scoliosis
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.

Healthy participants aged 10-18 with Cobb angle of less than 10 degreesPatients diagnosed with adolescent idiopathic scoliosis
Cobb angle measurementDIAGNOSTIC_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.

Also known as: Cobb method
Healthy participants aged 10-18 with Cobb angle of less than 10 degreesPatients diagnosed with adolescent idiopathic scoliosis

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.

Also known as: Assessment Tool
Healthy participants aged 10-18 with Cobb angle of less than 10 degreesPatients diagnosed with adolescent idiopathic scoliosis

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.

Healthy participants aged 10-18 with Cobb angle of less than 10 degreesPatients diagnosed with adolescent idiopathic scoliosis

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Research and Education Hospital

Istanbul, Gaziosmanpasa, 34255, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 17304528BACKGROUND
  • Sapsford 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.

    PMID: 14723856BACKGROUND
  • Koenig 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.

    PMID: 28716538BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2025

First Posted

July 20, 2025

Study Start

September 19, 2024

Primary Completion

February 1, 2025

Study Completion

August 1, 2025

Last Updated

February 10, 2026

Record last verified: 2025-07

Locations