Effectiveness of Scientific Exercise Approach to Scoliosis in Mild Idiopathic Scoliosis

NCT ID: NCT06039657

Last Updated: 2023-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2023-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Scoliosis Idiopathic Exercise Quality of Life Treatment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SEAS group

The SEAS therapy program comprised a one-year supervised exercise regimen. Supervised sessions were scheduled weekly for the initial month, bi-weekly for the second month, and monthly from the third to the sixth month. Thereafter, sessions were held bimonthly, each lasting one hour. Home exercises were designed to encompass 10-12 distinct exercises, with an approximate duration of 40-45 minutes per session

Group Type EXPERIMENTAL

SEAS training

Intervention Type OTHER

Patients who opted to participate in the SEAS group underwent SEAS therapy. The SEAS therapy program initially comrised patient education and active self-correction. Subsequently, stabilization of active self correction was tried to be performed through various functional activities. These activities were selected from everyday life examples, with increasing levels of difficulty over time. With SEAS exercises, the activation of self-correction was aimed to be increased through various activities in sitting, standing and walking conditions, with the goal of correcting scoliosis in this way

Standard Care Group

Standard care program aimed to provide patients with basic postural education and exercises in a single session, followed by one year of observation to ensure standard care.

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type OTHER

Patients who declined or were unable to participate in outpatient exercise programs received standard care. Standard care included exercises for postural re-education, traditional strengthening and stretching exercises for one session, followed by observation for one year.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SEAS training

Patients who opted to participate in the SEAS group underwent SEAS therapy. The SEAS therapy program initially comrised patient education and active self-correction. Subsequently, stabilization of active self correction was tried to be performed through various functional activities. These activities were selected from everyday life examples, with increasing levels of difficulty over time. With SEAS exercises, the activation of self-correction was aimed to be increased through various activities in sitting, standing and walking conditions, with the goal of correcting scoliosis in this way

Intervention Type OTHER

Standard Care

Patients who declined or were unable to participate in outpatient exercise programs received standard care. Standard care included exercises for postural re-education, traditional strengthening and stretching exercises for one session, followed by observation for one year.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gözde Yagci (Gür)

Assoc. Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Halil Gokhan Demirkiran, Prof

Role: STUDY_DIRECTOR

Hacettepe University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hacettepe University

Ankara, Samanpazari, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.

Reference Type BACKGROUND
PMID: 29435499 (View on PubMed)

Weinstein SL. The Natural History of Adolescent Idiopathic Scoliosis. J Pediatr Orthop. 2019 Jul;39(Issue 6, Supplement 1 Suppl 1):S44-S46. doi: 10.1097/BPO.0000000000001350.

Reference Type BACKGROUND
PMID: 31169647 (View on PubMed)

Gamiz-Bermudez F, Obrero-Gaitan E, Zagalaz-Anula N, Lomas-Vega R. Corrective exercise-based therapy for adolescent idiopathic scoliosis: Systematic review and meta-analysis. Clin Rehabil. 2022 May;36(5):597-608. doi: 10.1177/02692155211070452. Epub 2021 Dec 28.

Reference Type BACKGROUND
PMID: 34962437 (View on PubMed)

Berdishevsky H, Lebel VA, Bettany-Saltikov J, Rigo M, Lebel A, Hennes A, Romano M, Bialek M, M'hango A, Betts T, de Mauroy JC, Durmala J. Physiotherapy scoliosis-specific exercises - a comprehensive review of seven major schools. Scoliosis Spinal Disord. 2016 Aug 4;11:20. doi: 10.1186/s13013-016-0076-9. eCollection 2016.

Reference Type BACKGROUND
PMID: 27525315 (View on PubMed)

Romano M, Negrini A, Parzini S, Tavernaro M, Zaina F, Donzelli S, Negrini S. SEAS (Scientific Exercises Approach to Scoliosis): a modern and effective evidence based approach to physiotherapic specific scoliosis exercises. Scoliosis. 2015 Feb 5;10:3. doi: 10.1186/s13013-014-0027-2. eCollection 2015.

Reference Type BACKGROUND
PMID: 25729406 (View on PubMed)

Sanders JO, Harrast JJ, Kuklo TR, Polly DW, Bridwell KH, Diab M, Dormans JP, Drummond DS, Emans JB, Johnston CE 2nd, Lenke LG, McCarthy RE, Newton PO, Richards BS, Sucato DJ; Spinal Deformity Study Group. The Spinal Appearance Questionnaire: results of reliability, validity, and responsiveness testing in patients with idiopathic scoliosis. Spine (Phila Pa 1976). 2007 Nov 15;32(24):2719-22. doi: 10.1097/BRS.0b013e31815a5959.

Reference Type BACKGROUND
PMID: 18007251 (View on PubMed)

Asher M, Min Lai S, Burton D, Manna B. Discrimination validity of the scoliosis research society-22 patient questionnaire: relationship to idiopathic scoliosis curve pattern and curve size. Spine (Phila Pa 1976). 2003 Jan 1;28(1):74-8. doi: 10.1097/00007632-200301010-00017.

Reference Type BACKGROUND
PMID: 12544960 (View on PubMed)

Yagci G, Yakut Y. Core stabilization exercises versus scoliosis-specific exercises in moderate idiopathic scoliosis treatment. Prosthet Orthot Int. 2019 Jun;43(3):301-308. doi: 10.1177/0309364618820144. Epub 2019 Jan 10.

Reference Type BACKGROUND
PMID: 30628526 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GO16/82

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Posture Training for Middle Schoolers
NCT06909747 NOT_YET_RECRUITING NA
Physical Fitness in Autism
NCT04199507 COMPLETED