Self Correction Exercises for Idiopathic Scoliosis Among Adolescents. A Randomised Controlled Trial
Primary Purpose
Scoliosis Idiopathic
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Self Correction exercises
orthotic devices
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis Idiopathic
Eligibility Criteria
Inclusion Criteria:
- Subjects with idiopathic kyphoscoliosis and Cobb's angle greater than 60 degree and normal pulmonary function were included.
Exclusion Criteria:
- The subjects with other cardiovascular pathologies, congenital disorders and inability to commute were excluded from this study.
Sites / Locations
- Faizan Kashoo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise Group
Control Group
Arm Description
The experimental group received active self-correction exercises to restore movements in different planes as close as possible to physiologically normal.
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).
Outcomes
Primary Outcome Measures
Cobb angle
Angulation calculated on X-ray
SRS 22
Scoliosis rating scale 22 items
Secondary Outcome Measures
Full Information
NCT ID
NCT03779581
First Posted
December 17, 2018
Last Updated
February 27, 2023
Sponsor
Majmaah University
1. Study Identification
Unique Protocol Identification Number
NCT03779581
Brief Title
Self Correction Exercises for Idiopathic Scoliosis Among Adolescents. A Randomised Controlled Trial
Official Title
Self Correction Exercises for Idiopathic Scoliosis Among Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Majmaah University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1431 of the 108 subjects visiting out-patient Department of our hospital met the inclusion criteria. All the subjects diagnosed with kyphoscoliosis signed the informed consent approved by the ethical committee of the hospital. The diagnosis was based on the diagnosis by an experienced radiologist. Subjects with idiopathic kyphoscoliosis and Cobb's angle greater than 60 degree and normal pulmonary function were included. The subjects with other cardiovascular pathologies, congenital disorders and inability to commute were excluded from this study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The researcher, surgeons, and physiotherapist did not participate in randomization, treatment, or outcome assessments. The assessor was blinded. A computer-generated sequence inside pre-sealed opaque envelopes with sequentially numbered opaque envelopes randomly allocated individuals to the groups. To ensure a fair distribution of curve types between the two groups (54 per group), a random size (4-8) blocked randomization was stratified for the six curve types. Participants were asked not to reveal their group affiliations to ensure evaluators were blind. The statistician was also insulated from group allocation coding. During routine clinic visits, a trained technician blinded to study participation took radiographs. An expert blinded to groups and time measured the radiographs.
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
The experimental group received active self-correction exercises to restore movements in different planes as close as possible to physiologically normal.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Self Correction exercises
Intervention Description
Active self-correction exercises to restore movements in different planes as close to physiologically normal as possible.
Intervention Type
Device
Intervention Name(s)
orthotic devices
Intervention Description
the orthotic devices designed to correct the scoliosis curve
Primary Outcome Measure Information:
Title
Cobb angle
Description
Angulation calculated on X-ray
Time Frame
1-2 hours
Title
SRS 22
Description
Scoliosis rating scale 22 items
Time Frame
1-2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faizan Kashoo
City
Riyadh
ZIP/Postal Code
11952
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Self Correction Exercises for Idiopathic Scoliosis Among Adolescents. A Randomised Controlled Trial
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