New treatment approach for adolescent idiopathic scoliosis
Orthotic Management for Controlling Scoliotic Curve Progression in Adolescent Idiopathic Scoliosis
This study is testing a new lightweight undergarment and exercise program to see if it can help teenagers with mild scoliosis improve their spinal curvature without needing surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | Umm Al-Qura University Academic / other |
| Locations | 1 site (Mecca, Mecca Region) |
| Trial ID | NCT05819034 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a neuromuscular corrective approach for treating adolescent idiopathic scoliosis, a common spinal deformity in adolescents. It focuses on evaluating the effectiveness of a soft, lightweight orthotic undergarment called TheraTogs, combined with a scoliosis-specific exercise program. The goal is to control and reduce the degree of spinal curvature in adolescents diagnosed with mild non-structural scoliosis. By addressing the condition conservatively, the study seeks to improve the quality of life for affected adolescents and reduce the need for surgical interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 10-17 diagnosed with mild non-structural idiopathic scoliosis and a Cobb's angle between 10 and 25 degrees.
Not a fit: Patients with severe scoliosis (Cobb's angle > 25°), neurological disorders, or those who have undergone corrective surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive treatment option that effectively manages scoliosis in adolescents, improving their physical and psychological well-being.
How similar studies have performed: While conservative treatments for scoliosis have been explored, the specific use of TheraTogs in this context is a novel approach that has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
The inclusion criteria will be: * Adolescents of both sexes with an age range between 10-17 years. * They were diagnosed with Adolescent idiopathic scoliosis by an orthopedic specialist, confirmed through (loaded) X- rays. * They have mild non-structural scoliosis with Cobb's angle measurement of between 10 and 25 degrees * They have Single major thoracolumbar curve located between T6-7 to L1-2, apex at T12 or L1. * They have good health conditions except for scoliosis. * They can understand and communicate with no mental abnormalities. The exclusion criteria will be: * Adolescents with cerebral palsy or other degenerative neurological disorders; * Participants with nutritional disorders e.g. diabetes or vascular disorders. * Participants with a scoliotic curve with angle \> 25° will be excluded. * Participants will be excluded from this study if they have inflexible spinal deformities interfering with spinal mobility, * Participants who were subjected to any corrective surgery to their spine within the previous two years. * Participants will be also excluded if their skin were sensitive or inflamed to any materials used. * Participants who have seizures, perceptual disorders, visual problems, and auditory deficits * Participants who have leg length discrepancy * Participants who have scoliosis developed as a consequence of traumatic scoliosis.
Where this trial is running
Mecca, Mecca Region
- Umm Al Qura University — Mecca, Mecca Region, Saudi Arabia (Recruiting)
Study contacts
- Principal investigator: Ehab M Abd El Kafy, PhD — Department of Physical Therapy- Faculty of Applied Medical Sciences - Umm Al Qura University
- Study coordinator: Ehab M Abd El Kafy, PhD
- Email: emkafy@uqu.edu.sa
- Phone: +966531698541
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.