- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03779581
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
108
Phase
- 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
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Riyadh, Saudi Arabia, 11952
- Faizan Kashoo
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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
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 |
Intervention / Treatment |
---|---|
Experimental: Exercise Group
The experimental group received active self-correction exercises to restore movements in different planes as close as possible to physiologically normal.
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Active self-correction exercises to restore movements in different planes as close to physiologically normal as possible.
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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).
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the orthotic devices designed to correct the scoliosis curve
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cobb angle
Time Frame: 1-2 hours
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Angulation calculated on X-ray
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1-2 hours
|
SRS 22
Time Frame: 1-2 hours
|
Scoliosis rating scale 22 items
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1-2 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 1, 2018
Primary Completion (Actual)
May 1, 2022
Study Completion (Actual)
May 1, 2022
Study Registration Dates
First Submitted
December 17, 2018
First Submitted That Met QC Criteria
December 17, 2018
First Posted (Actual)
December 19, 2018
Study Record Updates
Last Update Posted (Actual)
March 1, 2023
Last Update Submitted That Met QC Criteria
February 27, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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