NCT05985902

Brief Summary

The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates. Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ disorders and pain. In addition, the quality of life in these individuals is also seen to decrease. There are no studies in the literature examining the effects of Schroth exercise training on trunk muscle strength, respiratory muscle strength, trunk muscle stiffness, balance and quality of life in children with adolescent idiopathic scoliosis. The aim of our study is to examine whether Schroth exercise training has an effect on trunk muscle strength, trunk muscle stiffness, respiratory muscle strength, balance, quality of life and perception of cosmetic deformity in children with adolescent idiopathic scoliosis. It is thought that this study will fill the gap in the literature with the original information it will bring to the literature and will shed light on future studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

July 25, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

July 24, 2023

Last Update Submit

April 21, 2026

Conditions

Keywords

Adolescent Idiopathic scoliosisSchroth ExercisesScoliosis Specific ExercisesTrunk Muscle StrengthRespiratory Muscle StrengthMuscle Stiffness

Outcome Measures

Primary Outcomes (8)

  • Isokinetic Muscle Strength

    In order to examine the muscle strength of the patients and the effectiveness of the treatment, the muscle strength of the individuals will be evaluated with the Biodex System 3-Pro (Biodex Medical Systems, Inc, New York, USA) isokinetic dynamometer device. The Biodex isokinetic dynamometer device adapts at a constant speed, allowing a dynamic test that can give resistance. The adaptiveness of the resistance and the ability to give the same resistance throughout the entire range of motion provide maximum muscle strength. In addition to this situation, the performance of the muscles can be evaluated at different angular velocities. Muscle function and muscle strength can be determined during maximum muscle contraction by using a linear scale with isokinetic dynamometer, which is an objective assessment, and with this method, information about the strength of the upper and lower extremities and trunk muscles can be obtained.

    Baseline and after 12 weeks

  • Muscle Stiffness

    Shear Wave Elastography, also known as dynamic elastography, is a sonoelastography examination that has been developed and rapidly developed in recent years, and it provides additional information about tissue properties by evaluating tissue flexibility that can contribute to the diagnosis. In this technique application, a short-term, high-power acoustic repulsive radiation force is applied to the tissue with ultrasound probes. This force causes small displacements in tissues. These displacements in the horizontal plane are called "shear waves" and the rate of progression of these waves in the tissue can be measured. The shear wave velocity is directly proportional to the hardness of the tissue. The velocity values obtained show the objective elasticity values. Patients' spinal and abdominal muscle stiffness will be evaluated with the Toshiba Aplio 500 (Toshiba Medical Systems Corporation, Japan).

    Baseline and after 12 weeks

  • Respiratory Muscle Strength

    Respiratory muscle strength will be measured with a portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical; UK). Pressures will be assessed by measurements of maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) during a few seconds of maximal inspiration (Müller maneuver) and expiration (Valsalva maneuver) by mouth.

    Baseline and after 12 weeks

  • Postural Stability

    Postural Stability and balance will be evaluated with the Biodex Balance System®. The Biodex Balance System® is a validated and reliable instrument used to assess postural stability, limits of stability and fall risk. It consists of balance platform, arm supports, screen and printer. The platform can be adjusted as static or mobile (12 levels of movement amount; level 12 is the most stable, level 1 is the least stable level that can move up to 20 degrees in each direction) according to the test to be applied.

    Baseline and after 12 weeks

  • Cobb Angle

    The Cobb angle records at the first visit of the patients. The Cobb angle is the angle between the lines drawn perpendicular to the endplates first and last vertebrae involved in the curvature.

    Baseline and after 12 weeks

  • Angle of Trunk Rotation

    Measurement will be applied with Bunnell Scoliometer by physiotherapist.

    Baseline and after 12 weeks

  • Quality of Life (Scoliosis Research Society-22)

    Measurement will be applied with Scoliosis Research Society-22 Questionnaire. The scale consists of 22 questions and 5 subgroups of questions. Subgroups; pain, evaluation of general appearance, spinal functions, mental health and satisfaction with treatment. All of these sections can be evaluated separately and/or all questions can be evaluated by summing up under the total score. Scores are calculated by assigning an answer value to all 22 questions within a 5-point indicator chart. Each statement has responses ranging from negative to positive. The most negative answer; 1 and the most positive gets 5 points. High scores on the scale indicate an increase in quality of life, and low scores indicate a decrease.

    Baseline and after 12 weeks

  • Cosmetic Deformity Perception

    Measurement will be applied with The Walter Reed Visual Assessment Scale. In the scale, deformity is categorized with 7 different aspects. Each of the 7 items contains a set of 5 figures representing the severity of the deformity. In these sets, there are visuals evaluating spine deformity, rib protrusion, waist protrusion, chest deformity, trunk imbalance, shoulder asymmetry and scapular asymmetry. The visuals include posterior views of the deformity and assess the patient's sense of how other people see their back. The selected images are scored as the lowest "1" and the highest "5", and the higher the total score obtained, the more negative-worse the perceived deformity is defined.

    Baseline and after 12 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Core stabilization exercise training will be given to the control group for 12 weeks, 7 days a week, for 60 minutes. Core stabilization exercises will be applied to this group under the supervision of a physiotherapist for 2 days in our unit, while home-based core stabilization exercise training will be given on other days of the week.

Other: Core Stabilization Exercises

Training Group

EXPERIMENTAL

After the first evaluation, the training group will be given Schroth exercise training for 12 weeks, 7 days a week, for 60 minutes. This group will be given Schroth exercises under the supervision of a physiotherapist for 2 days in our unit, while home-based Schroth exercise training will be given on other days of the week.

Other: Schroth Exercises

Interventions

Core stabilization training; exercises for 2 muscle systems that contribute to spinal stability are given. The first one is the "local system" muscles; multifidus, transversus abdominis, diaphragm and pelvic floor muscles. The second, the "global system" includes large superficial muscles, such as erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus ma

Control Group

In the Schroth exercise training, there are 3-dimensional exercises that include the principles of axial reach, deflection, derotation, rotational breathing and stabilization.

Training Group

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with AIS scoliosis
  • Individuals agreeing to participate in the study
  • Patients between the ages of 10-20
  • Patients with AIS whose Cobb angle measured on X-ray is between 15-40 degrees

You may not qualify if:

  • Documented diagnosis any of cardiopulmonary, neurological, orthopedic or mental disorders which may affect the assessments results.
  • Patients previously undertaken any of spinal surgeries.
  • Patients involved in exercise training 3 or more days a week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Eyüp, 34050, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2023

First Posted

August 14, 2023

Study Start

July 25, 2023

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations