Effectiveness of Scientific Exercise Approach to Scoliosis in Mild Idiopathic Scoliosis

NCT06039657 | Completed

• 1 other identifier: GO16/82
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis Idiopathic; Exercise; Quality of Life; Treatment

Keywords

scoliosis; exercise therapy; quality of life; physical appearance

Outcome Measures

Primary Outcomes (1)

• Cobb angle

  The Cobb angle was used to quantify the degree of spinal curvature in scoliosis, determined by the angle formed by lines drawn along the endplates of the vertebrae at the curve's apex and endpoints

  Measurements were performed at baseline and at the end of the one-year treatment period.

Secondary Outcomes (3)

• Axial trunk rotation

  Measurements were performed at baseline and at the end of the one-year treatment period.

• Spinal Appearance Questionnaire (SAQ)

  Measurements were performed at baseline and at the end of the one-year treatment period.

• Scoliosis Research Questionnaire-22 (SRS-22)

  Measurements were performed at baseline and at the end of the one-year treatment period.

Study Arms (2)

SEAS group

EXPERIMENTAL

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

Other: SEAS training

Standard Care Group

ACTIVE COMPARATOR

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.

Other: Standard Care

Interventions

SEAS training 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

SEAS group

Standard Care 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.

Standard Care Group

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Samanpazari, 06100, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 29435499 BACKGROUND

• 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.

  PMID: 31169647 BACKGROUND

• 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.

  PMID: 34962437 BACKGROUND

• 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.

  PMID: 27525315 BACKGROUND

• 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.

  PMID: 25729406 BACKGROUND

• 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.

  PMID: 18007251 BACKGROUND

• 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.

  PMID: 12544960 BACKGROUND

• 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.

  PMID: 30628526 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Scoliosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Halil Gokhan Demirkiran, Prof

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 15, 2023
• Study Start: June 1, 2019
• Primary Completion: September 20, 2022
• Study Completion: March 30, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)