Conservative Management for Adolescent Idiopathic Scoliosis
- Conditions
- Scoliosis; Adolescence
- Interventions
- Other: Scoliosis-Specific Exercise ProgramOther: Soft orthoses with external strapping.
- Registration Number
- NCT05819034
- Lead Sponsor
- Umm Al-Qura University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group 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. Control Group Scoliosis-Specific Exercise Program Adolescents in the control group will receive a scoliosis-specific exercise program which will be prescribed to control the progression of the scoliotic curve Experimental Group Soft orthoses with external strapping. 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.
- Primary Outcome Measures
Name Time Method Change in the scoliotic cobb's angle (°) [Data was collected at baseline, and 12 weeks after intervention commencement.] X-ray imaging will be measured by a radiologist
Changes in the Pelvic Obliquity (mm) [Data was collected at baseline, and 12 weeks after intervention commencement.] 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.
Change in the vertebral rotation (Angle) [Data was collected at baseline, and 12 weeks after intervention commencement.] 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.
Change in the Coronal imbalance (mm) [Data was collected at baseline, and 12 weeks after intervention commencement.] 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Umm Al Qura University
🇸🇦Mecca, Saudi Arabia