Clinical trial NCT06039657: Effectiveness of Scientific Exercise Approach to Scoliosis in Mild Idiopathic Scoliosis
Official title: Effectiveness of Scientific Exercise Approach to Scoliosis in Adolescents With Mild Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis Idiopathic
Exercise
Quality of Life
Treatment
Keywords: scoliosis
exercise therapy
quality of life
physical appearance
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 32
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: İdiopathic scoliosis is a three dimensional deformity with lateral deviation and rotation of the spine. In idiopathic scoliosis, scoliosis-specific exercises are utilized as a primary treatment for moderate curves and as a supportive measure alongside bracing for more severe curves. SEAS, which stands for Scientific Exercises Approach to Scoliosis, refers to a treatment approach developed as a scientific exercise methodology for scoliosis. This approach aims to provide scoliosis-specific exercises and techniques to manage and potentially improve the condition. This study aims to investigate the effectiveness of SEAS as a conservative treatment approach for mild AIS.

Detailed description: Adolescent idiopathic scoliosis (AIS) constitutes a multifaceted distortion involving three-dimensional structural curvature of the spine, accompanied by biomechanical alterations that advance gradually, exerting an adverse influence on the quality of life related to health in individuals ranging from 10 to 18 years of age. In idiopathic scoliosis, curvatures ranging from 10 to 25 degrees are categorized as mild, while curvatures between 25 and 45 degrees are considered moderate, and those exceeding 45 degrees are classified as severe. For mild scoliosis, scoliosis specific exercises are the main treatment method. SEAS (Scientific Exercises Approach to Scoliosis), a specific type of scoliosis specific exercise program, focuses on using scientific principles to address the unique needs of individuals with scoliosis. It aims to improve posture, spinal alignment, and muscle balance through tailored exercises. SEAS exercises involve three-dimensional spinal correction and are designed to enhance neuromuscular control and proprioception in this corrective position. The available research regarding SEAS in adolescent idiopathic scoliosis (AIS) is somewhat limited both in terms of quantity and scope, underscoring the necessity for more comprehensive investigations. Drawing from the existing literature landscape and the identified gaps, our hypothesis centers on the notion that the incorporation of SEAS is poised to yield noteworthy enhancements across various dimensions of AIS. Consequently, the primary objective of this study was to assess the efficacy of SEAS training in ameliorating parameters such as Cobb angle, axial trunk rotation, bodily aesthetics, and health-related quality of life in individuals diagnosed with mild AIS. Patients in this study were treated using two different protocols based on a shared decision-making model. Patients and their families were informed about the pathology, history and progression risk of idiopathic scoliosis, as well as the exercise options and expected outcomes. Consequently, every patient along with their parents comprehensively grasped the significance of scoliosis-specific exercises in proactively rectifying and maintaining their spinal alignment throughout diverse functional activities. Patients who choose for exercise treatment underwent SEAS therapy, while those who declined or were unable to participate in outpatient exercise programs received standard care.

Eligibility criteria: Inclusion Criteria:

* Patients with Adolescent Idiopathic Scoliosis (AIS).
* A Cobb angle measurement falling within the range of 12° to 25°.
* Patients considered for the study were required to be within the age range of 10 to 16 years old.
* have a Risser score ranging from 0 to 4.

Exclusion Criteria:

* Patients with a history of prior spine treatment, including surgery or conservative treatment
* Patients with a history of traumatic spinal injury
* Individuals with rheumatologic disorders, which affect the joints and connective tissues
* Patients with systemic disorders, which affect multiple organ systems in the body
* Those with neurologic disorders, impacting the nervous system
* Individuals with any other musculoskeletal disorders

Primary outcomes:
measure: Cobb angle
timeFrame: Measurements were performed at baseline and at the end of the one-year treatment period.
Secondary outcomes:
measure: Axial trunk rotation
timeFrame: Measurements were performed at baseline and at the end of the one-year treatment period.
measure: Spinal Appearance Questionnaire (SAQ)
timeFrame: Measurements were performed at baseline and at the end of the one-year treatment period.
measure: Scoliosis Research Questionnaire-22 (SRS-22)
timeFrame: Measurements were performed at baseline and at the end of the one-year treatment period.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Samanpazari
Study officials:
affiliation: Hacettepe University
name: Halil Gokhan Demirkiran, Prof
role: STUDY_DIRECTOR
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