Self Correction Exercises for Idiopathic Scoliosis Among Adolescents. A Randomised Controlled Trial

February 27, 2023 updated by: faizan kashoo, PT, Majmaah University

Self Correction Exercises for Idiopathic Scoliosis Among Adolescents

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity with an unknown cause that affects adolescents aged 10 or older. A standing posterior-anterior radiograph with a Cobb angle greater than 10 degrees is used to make the diagnosis. Depending on the severity of the spinal deformity, conservative treatments and surgery are used to treat AIS. Patients whose spinal curvature is greater than 45 degrees are typically considered for surgery. The majority of patients with AIS receive conservative treatments to prevent and slow the progression of the curve. 2 Orthotic intervention (OI) and scoliosis-specific exercise (SSE) are commonly recommended by the International Society on Scoliosis Orthopaedic and Rehabilitation Treatment for patients with a curvature between 20 and 45 degrees. Self correction exercises are the group of spinal extension, lateral spinal flexion and rotational exercises performed to correct spinal deviation. Exercises are performed in a different fundamental postures.

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

Scoliosis is a malformation of the musculoskeletal system that is defined by lateral deviation of the spine, which is typically accompanied by vertebral rotation and lordosis. The term "scoliosis" refers to the curvature of the spine that results from the condition (3-dimensional deformity). Scoliosis in female teenagers often reaches its most advanced stage between the ages of 11 and 16 years old. In general, scoliosis may be broken down into two categories: structural and non-structural scoliosis. The level of severity and the degree of deformity of the spine are the major characteristics that differentiate the two groups. It is common practice to refer to the structural type of scoliosis as a sort of spinal deformity that cannot be corrected without surgical intervention. Bracing, exercises, and education are some of the conservative treatments that may be used to control non-structural spinal deformity, which is a movable disorder. Scoliosis that is not treated properly may advance to a functionally degraded condition, which is characterized by physical asymmetry, muscular imbalance, back discomfort, and considerable respiratory disruption. This can lead to distorted body image and a loss of self-esteem in the patient. Idiopathic adolescent scoliosis, more commonly known as AIS, is the diagnosis that is typically made in children who are otherwise healthy but have a spinal curvature of at least ten degrees but less than fifty degrees. This curvature range is what determines whether a child is considered to have AIS. While treating scoliosis, the primary goal of therapy should be to slow or stop the disease's development so that the treatment may be regarded effective. Non-conservative therapies often entail surgical techniques for the correction of spinal abnormalities; nevertheless, these operations do not come without associated risks. Individuals who arrive with a scoliosis curvature of less than 40 degrees have the potential to be candidates for conservative treatments such as physiotherapy scoliosis-specific exercise (PSSE), with or without the concomitant use of an external brace.

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.
108

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

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

10 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

10-16-year-olds with AIS, all sexes, all curve kinds, curves between 10° and 45°, Risser grade 0 to 5, with or without brace, and the capacity to attend weekly checkups.

Exclusion criteria included patients with a diagnosis other than AIS, those who had finished brace therapy, those planned for surgery, those with a follow-up scheduled beyond 62 months, and those who had had prior spine surgery.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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: Exercise Group
The experimental group received active self-correction exercises to restore movements in different planes as close as possible to physiologically normal.
Other: Self Correction exercises
Active self-correction exercises to restore movements in different planes as close to physiologically normal as possible.
Active Comparator: Control Group
All patients were prescribed a spinal orthosis (TLSO) and got a preliminary evaluation for orthosis design and manufacturing based on the curve type categorization from Ross and Weiss during the first appointment (Rigo et al., 2010).
Device: orthotic devices
the orthotic devices designed to correct the scoliosis curve

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: 1-2 hours
Angulation calculated on X-ray
1-2 hours
SRS 22
Time Frame: 1-2 hours
Scoliosis rating scale 22 items
1-2 hours

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.
Majmaah University

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.
January 1, 2018

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.
May 1, 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.
May 1, 2022

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).
December 17, 2018

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.
December 17, 2018

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.
December 19, 2018

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.
March 1, 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.
February 27, 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.
February 1, 2023

More Information

Terms related to this study

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.
  • MajmaahUniversity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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