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Effectiveness of Scientific Exercise Approach to Scoliosis in Mild Idiopathic Scoliosis

Primary Purpose

Scoliosis Idiopathic, Exercise, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
SEAS training
Standard Care
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis Idiopathic focused on measuring scoliosis, exercise therapy, quality of life, physical appearance

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SEAS group

Standard Care Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Axial trunk rotation
Axial trunk rotation measurement in the Adams test was used to the assessment of the degree of rotation of the patient's trunk while they bend forward at the waist with their arms extended downward, helping to identify any asymmetry or abnormal spinal curvature associated with scoliosis.
Spinal Appearance Questionnaire (SAQ)
The Spinal Appearance Questionnaire was used as a self-reporting assessment tool used in the evaluation of individuals with spinal deformities, particularly scoliosis. It consists of a series of questions or statements designed to gather information about the patient's perception of their spinal appearance, including factors like posture, symmetry, and body image, to help in treatment planning and assessing the impact of spinal deformities on their quality of life.
Scoliosis Research Questionnaire-22 (SRS-22)
SRS-22 was used in the evaluation of patients with scoliosis or spinal deformities. It assesses the patient's health-related quality of life and function through a series of questions related to pain, function, self-image, and mental health.

Full Information

First Posted
September 6, 2023
Last Updated
September 13, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT06039657
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
September 20, 2022 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic, Exercise, Quality of Life, Treatment
Keywords
scoliosis, exercise therapy, quality of life, physical appearance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SEAS group
Arm Type
Experimental
Arm Description
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
Arm Title
Standard Care Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
SEAS training
Intervention Description
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
Intervention Name(s)
Standard Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cobb angle
Description
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
Time Frame
Measurements were performed at baseline and at the end of the one-year treatment period.
Secondary Outcome Measure Information:
Title
Axial trunk rotation
Description
Axial trunk rotation measurement in the Adams test was used to the assessment of the degree of rotation of the patient's trunk while they bend forward at the waist with their arms extended downward, helping to identify any asymmetry or abnormal spinal curvature associated with scoliosis.
Time Frame
Measurements were performed at baseline and at the end of the one-year treatment period.
Title
Spinal Appearance Questionnaire (SAQ)
Description
The Spinal Appearance Questionnaire was used as a self-reporting assessment tool used in the evaluation of individuals with spinal deformities, particularly scoliosis. It consists of a series of questions or statements designed to gather information about the patient's perception of their spinal appearance, including factors like posture, symmetry, and body image, to help in treatment planning and assessing the impact of spinal deformities on their quality of life.
Time Frame
Measurements were performed at baseline and at the end of the one-year treatment period.
Title
Scoliosis Research Questionnaire-22 (SRS-22)
Description
SRS-22 was used in the evaluation of patients with scoliosis or spinal deformities. It assesses the patient's health-related quality of life and function through a series of questions related to pain, function, self-image, and mental health.
Time Frame
Measurements were performed at baseline and at the end of the one-year treatment period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halil Gokhan Demirkiran, Prof
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University
City
Ankara
State/Province
Samanpazari
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29435499
Citation
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.
Results Reference
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PubMed Identifier
31169647
Citation
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.
Results Reference
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PubMed Identifier
34962437
Citation
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.
Results Reference
background
PubMed Identifier
27525315
Citation
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.
Results Reference
background
PubMed Identifier
25729406
Citation
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.
Results Reference
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PubMed Identifier
18007251
Citation
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.
Results Reference
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PubMed Identifier
12544960
Citation
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.
Results Reference
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Citation
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.
Results Reference
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Effectiveness of Scientific Exercise Approach to Scoliosis in Mild Idiopathic Scoliosis

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