An interventional study of Scoliosis-Specific Exercise Program and Soft orthoses with external strapping. in Scoliosis; Adolescence, sponsored by Umm Al-Qura University. Completed at 1 site in Saudi Arabia. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Umm Al-Qura University · Not applicable, Interventional, and Treatment
Idiopathic scoliosis is a living problem that resists correction. The underlying cause of the such disorder is unknown but directed more toward muscular disorders. However recent clinical observation showed a possible neuromuscular compromise early in those patients. The main purpose of this study is to develop a treatment procedure to correct the degree of bony curvature in patients with Idiopathic scoliosis through developing a neuromuscular corrective approach that might be a more effective conservative treatment protocol for such disorder.
Scoliosis is one of the most common spinal deformities occurring in school-going children during the growth spurts of adolescents. It is an abnormal curvature of the spine. Failure of early management of idiopathic scoliosis could lead to multiple problems related to postural malalignment, pulmonary and physical dysfunctions, and surgical interventions. These problems could lead to health-related quality-of-life issues such as psychological and social problems that are represented in social isolation, depression, loss of self-confidence, limited job opportunities, and hospital stays \& days off school and university as a result of undergoing corrective surgeries. Treatment methods for adolescent idiopathic Scoliosis (AIS) vary between surgical intervention and conservative treatment, in mild and moderate cases. Conservative treatment includes physical therapy in addition to rigid splints and braces, which may cause pain, tightness, restriction of movement, and a bad psychological status for adolescents which may lead them to the irregular wearing of these splints and braces. A type of soft, lightweight, breathable orthosis which is TheraTogs orthotic undergarment with the strapping system has been fabricated to provide gentle, passive compression to correct spinal deformities. Therefore, the objective of this study is to evaluate the effectiveness of TheraTogs orthotic undergarment with the strapping system on controlling and modulating the degree of scoliosis in Saudi adolescents with idiopathic scoliosis.
660 studies on the registry are indexed under Scoliosis; 186 are open to participants now.
This study's enrollment of 60 is above the median of 45 across 386 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →Umm Al-Qura University is the lead sponsor of 47 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The inclusion criteria will be:
The exclusion criteria will be:
Adolescents in the control group will receive a scoliosis-specific exercise program which will be prescribed to control the progression of the scoliotic curve
Other: Scoliosis-Specific Exercise Program
Adolescents in the experimental group will receive a scoliosis-specific exercise program which will be prescribed to control the progression of the scoliotic curve in addition to wearing the soft orthoses with external strapping.
Other: Scoliosis-Specific Exercise Program · Other: Soft orthoses with external strapping.
Adolescents in the control group will receive a scoliosis-specific exercise program which will be prescribed to control the progression of the scoliotic curve. This exercise program will include frontal plane active or passive correction exercises for scoliotic posture. The exercise program for every participant will be three sessions per week for 12 successive weeks. Every treatment session was applied for one hour.The exercise program for every participant will be three sessions per week for 12 successive weeks. Every treatment session was applied for one hour. The exercise program for every participant will be three sessions per week for 12 successive weeks. Every treatment session was applied for one hour.
Adolescents in the experimental group will receive a scoliosis-specific exercises program which will be prescribed to control the progression of the scoliotic curve in addition to wearing the soft orthoses with external strapping. The wearing schedule of the soft orthosis with the external strapping for every participant in this group will be 12 hours daily for 12 successive weeks.
Change in the scoliotic cobb's angle (°)
X-ray imaging will be measured by a radiologist
Time frame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
Changes in the Pelvic Obliquity (mm)
The following device (DIERS Formetric 3D/4D spine \& posture analysis system) will be used to examine the changes in the spinal vertebral parameters in different planes (sagittal, coronal and transverse). This device supplies a thorough report about the alignment of the whole spine in one assessment session.
Time frame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
Change in the vertebral rotation (Angle)
The following device (DIERS Formetric 3D/4D spine \& posture analysis system) will be used to examine the changes in the spinal vertebral parameters in different planes (sagittal, coronal and transverse). This device supplies a thorough report about the alignment of the whole spine in one assessment session.
Time frame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
Change in the Coronal imbalance (mm)
The following device (DIERS Formetric 3D/4D spine \& posture analysis system) will be used to examine the changes in the spinal vertebral parameters in different planes (sagittal, coronal and transverse). This device supplies a thorough report about the alignment of the whole spine in one assessment session.
Time frame: [Data was collected at baseline, and 12 weeks after intervention commencement.]
Plan to share: Yes — - The data available is Case-by-case basis at the discretion of the Primary Sponsor
Supporting information: Statistical analysis plan
Time frame: Start Date: Beginning one year following main results publication End Date: Ending two years following main results publication
Access criteria: Data can be obtained by Principal Investigator Email Address: emkafy@uqu.edu.sa
No publications or documents are linked to this record.
Ran from Feb 2024 to primary completion in Dec 2025, 22 months.
Of 223 non-industry interventional studies with no phase under Scoliosis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 58. This study's 22 months is close to that.
Counting every sponsor, half of 233 studies reached it within 22 months; a quarter within 8 and three quarters within 60.
Completion moved once since we started tracking on Sep 25, 2026: Dec 2025 → May 2026, on Nov 3, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Umm Al-Qura University