Orthotic Management for Controlling Scoliotic Curve Progression in Adolescent Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in the scoliotic cobb's angle (°)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 L
- •They have good health conditions except for scoliosis.
- •They can understand and communicate with no mental abnormalities.
排除标准
- •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.
研究组 & 干预措施
Control Group
Adolescents in the control group will receive a scoliosis-specific exercise program which will be prescribed to control the progression of the scoliotic curve
干预措施: Scoliosis-Specific Exercise Program (Other)
Experimental Group
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.
干预措施: Scoliosis-Specific Exercise Program (Other)
Experimental Group
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.
干预措施: Soft orthoses with external strapping. (Other)
结局指标
主要结局
Change in the scoliotic cobb's angle (°)
时间窗: [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)
时间窗: [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)
时间窗: [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)
时间窗: [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.
次要结局
未报告次要终点
研究者
Ehab Mohamed Abd El Kafy
Professor of Physical Therapy
Umm Al-Qura University