Effectiveness of Scientific Exercise Approach to Scoliosis in Mild Idiopathic Scoliosis

September 13, 2023 updated by: Gözde Yagci (Gür), Hacettepe University

Effectiveness of Scientific Exercise Approach to Scoliosis in Adolescents With Mild Idiopathic Scoliosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Samanpazari
      • Ankara, Samanpazari, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Other: 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
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cobb angle
Time Frame: Measurements were performed at baseline and at the end of the one-year treatment period.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Axial trunk rotation
Time Frame: Measurements were performed at baseline and at the end of the one-year treatment period.
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.
Measurements were performed at baseline and at the end of the one-year treatment period.
Spinal Appearance Questionnaire (SAQ)
Time Frame: Measurements were performed at baseline and at the end of the one-year treatment period.
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.
Measurements were performed at baseline and at the end of the one-year treatment period.
Scoliosis Research Questionnaire-22 (SRS-22)
Time Frame: Measurements were performed at baseline and at the end of the one-year treatment period.
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.
Measurements were performed at baseline and at the end of the one-year treatment period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Halil Gokhan Demirkiran, Prof, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO16/82

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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