NCT06224998

Brief Summary

Adolescent idiopathic scoliosis (AIS) is a common anomaly that is frequently seen in prepubertal growth and is characterized by deviation and rotation of the spine, causing high level of disability. Pubertal development and asymmetrical load distribution increase the progression of the deformity. Affecting the spinal structure and its movement can affect the structures and cause problems in many areas such as pain, balance, respiration, mental health and quality of life. AIS can cause functional disability by causing deterioration in chest wall mechanics, weakness in respiratory muscles and limitation of functional capacity. As the disease progresses, prolonged hypoinflation and atelectasis lead to irreversible atrophy of the lungs and further reduction in lung volume. Displacement and/or compression of the heart due to thoracic deformity may not allow for the required increase in stroke volume during exercise. In severe cases, patients are at risk of developing pulmonary hypertension due to chronic respiratory failure and chronic atelectasis, chronic hypoxemia, chronic hypercapnia. In addition, muscle atrophy and muscle weakness in AIS are thought to cause muscle imbalances and loss of balance. Exercise is the most appropriate treatment for low and moderate AIS cases due to its low cost and low risk of complications. Exercises prevent the development of many problems by controlling the severity of curvature and preventing the progression of curvature. It is thought that scoliosis exercises can delay or even prevent surgery and reduce the duration or degree of brace, especially in patients with low-to-moderate curvature during growth. One of these exercise approaches, the Schroth technique, is primarily based on isometric muscle contraction exercises that aim to rotate, lengthen and stabilize the spine. The core component of the Schroth method is autocorrection, defined as the patient's ability to reduce spinal deformity through active postural realignment of the spine in three dimensions. Another frequently used exercise method, Pilates exercise training improves flexibility and overall physical health by emphasizing the coordination of movements associated with strength, posture, and breathing. However, the effects of these exercises in reducing curvature and related problems are controversial in the literature. Therefore, in this study, we aimed to investigate the effects of Schroth and pilates exercises on respiratory functions, functional capacity, balance, spine structure and quality of life in adolescents with idiopathic scoliosis. Thirty patients aged 10 to 18 years, with a Cobb angle between 10 and 25 degrees, will be included in the study. The subjects will be randomly divided into two groups; Schroth exercises will be applied to one group and pilates exercises will be applied to another group. All participants will participate in exercise sessions of 60 minutes a day, 3 days a week, for 8 weeks. Each participant will receive a total of 24 sessions of exercise therapy under the supervision of a physiotherapist. In this study, exercises that activate the muscle groups responsible for maintaining the correct posture and correcting the curvature will be selected for practice. Within the study, axial trunk rotation with a scoliometer, respiratory functions and respiratory muscle strength measurement with spirometry, functional capacity with the 6-minute walking test, balance with the Tecnobody balance measuring device, quality of life with Scoliosis will be assessed by the Research Society-22 Quality of Life Questionnaire. The results obtained from the study are of great importance as they will help to determine the effects of Schroth and pilates exercises on spinal deformity and the treatment of related problems in patients with AIS and to establish appropriate programs for the prevention and treatment of these problems.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Study Start

First participant enrolled

November 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 11, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

December 11, 2023

Last Update Submit

June 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • respiratory functions

    These measurements include forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and peak flow rate. (PEF), 25-75% flow rate of forced vital capacity (FEF25-75), expected values according to age, height, and weight and their percentages, and the ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC) will be recorded. MIP will be obtained by measuring the intraoral pressure during maximum inspiration against a closed valve for 1-3 seconds after maximum expiration. MEP will be obtained by measuring the intraoral pressure during maximum inspiration against a closed valve for 1-2 seconds after maximum inspiration.

    2 years

  • spine structure

    A scoliometer will be used to evaluate axial trunk rotation. Scoliometer is used to measure the rotational severity of the curvature of the vertebra in the horizontal plane. The patient will be asked to stand in a standing position, with the feet slightly open, stretching his arms forward and joining his hands with the palms facing each other. Then, he/she will be asked to lean forward until his/her body is horizontal by putting his/her hands between his/her knees without bending his/her knees. The scoliometer will be placed at the apex by the therapist positioned behind the patient, and the rotation value shown by the scoliometer will be recorded in degrees. While the interpersonal reliability of the scoliometer was found to be "excellent", its inter-measurement reliability was stated to be "very good".

    2 years

Secondary Outcomes (3)

  • functional capacity

    2 years

  • balance

    2 years

  • quality of life of the participants

    2 years

Study Arms (2)

Schroth exercises

EXPERIMENTAL

Schroth technique, one of these exercise approaches, is primarily based on isometric muscle contraction exercises that aim to rotate, lengthen and stabilize the spine. The key component of the Schroth method is autocorrection, defined as the patient's ability to reduce spinal deformity through active postural realignment of the spine in three dimensions. Automatic correction is achieved through self-extension and specific segmental corrections adapted to each curve pattern. The International Scoliosis Orthopedic Treatment and Rehabilitation Association considers automatic correction to be the most important element of scoliosis-specific exercise therapy.

Behavioral: Exercise

Pilates exercises

EXPERIMENTAL

Pilates exercise training improves flexibility and overall physical health by emphasizing strength, posture and coordination of respiratory-related movements. Pilates improves body awareness by working the body as a whole, using gravity and springs to increase resistance and assist in the execution of movements. Pilates, used in neuromuscular training and functional activity training in physiotherapy, is widely used for stimulation of blood circulation, development of flexibility, muscle endurance and strength, postural harmony and body awareness. Pilates has been reported to be an effective physical technique for pain, symptom management, and improving the Cobb angle in scoliosis. Pilates has been reported to be effective in improving scoliosis by correcting poor posture, strengthening the muscles necessary for postural correction, and maintaining body balance.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Exercise is the most appropriate treatment for low and moderate AIS cases due to its low cost and low risk of complications. Exercises prevent the development of many problems by controlling the severity of curvature and preventing the progression of curvature. It is thought that scoliosis exercises can delay or even prevent surgery and reduce the duration or degree of brace, especially in patients with low-to-moderate curvature during growth. One of these exercise approaches, the Schroth technique, is primarily based on isometric muscle contraction exercises that aim to rotate, lengthen and stabilize the spine. The core component of the Schroth method is autocorrection, defined as the patient's ability to reduce spinal deformity through active postural realignment of the spine in three dimensions.

Pilates exercisesSchroth exercises

Eligibility Criteria

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

You may qualify if:

  • having a Cobb angle between 10 and 25 degrees
  • age between 10-18 years

You may not qualify if:

  • Presence of secondary scoliosis (congenital, muscular and neurological scoliosis)
  • Presence of any cardiovascular and pulmonary disease that will prevent respiratory functions
  • Having a history of thoracic surgery
  • Use of assistive devices
  • Presence of a secondary orthopedic problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Izmir Katip Celebi University

Izmir, Turkey (Türkiye)

RECRUITING

İzmir Katip Çelebi University

Izmir, Turkey (Türkiye)

ENROLLING BY INVITATION

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • sevtap gunay ucurum

    İzmir Katip Çelebi University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

kevser kacmaz, pt, phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research asisstant

Study Record Dates

First Submitted

December 11, 2023

First Posted

January 25, 2024

Study Start

November 1, 2023

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

June 24, 2025

Record last verified: 2025-06

Locations