Investigation of the Efficiency of Spinal Mobilization in Patients With Adolescent Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Cobb angle
研究概览
简要总结
In this study, it was aimed to evaluate the effect of spinal mobilization techniques applied in addition to core stabilization exercises in Adolescent Idiopathic Scoliosis (AIS) patients.
Consecutive adolescents with idiopathic scoliosis, aged 10 to 16 years, without a brace, and with a Cobb curvature of 10 to 25 degrees were randomly divided into two groups using the closed envelope method: Spinal mobilization and core stabilization exercise were applied to the experimental group; Only core stabilization exercises were applied to the control group.
Both groups received interventions twice a week for 10 weeks. Outcome measurements were made before treatment and after 10 weeks of treatment.
详细描述
This study was a randomized controlled trial in which participants and assessor were blinded. This study was carried out in Amasya University Ruhi Tingiz Physical Therapy and Rehabilitation Hospital Rehabilitation Unit between August 2022 and January 2023. Ethics committee approval was obtained from Amasya University (E-76988455-050.01.04-83314) on 05.08.2022 to conduct the study. Before the study, face-to-face interviews were conducted with the all participants and parents and informed about the subject and purpose of the study. Verbal and written consent was obtained from the all participants and parents.
Sample size: The sample of the study was calculated with the G*Power 3.1 program, and the effect size (d=1.0) was calculated according to the double-tailed hypothesis method, taking into account the study. (d=1.0; α=0.05; 1-ß=0.80). Confidence interval was determined as 80% and margin of error was 5% (α=0.05). As a result of the calculation, it was determined that there should be 17 adolescent scoliosis patients for the control group, 17 for the experimental group, and a total of 34 adolescent scoliosis patients. Considering the possible data losses of the participants, we planned to include a total of 40 participants, 20 in both groups.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with AIS
- •Age 10-16 years
- •Cobb angle was between 10° and 25
- •Risser sing did not exceed 4
- •Informed consent forms were signed by the parents and children
排除标准
- •Used brace,
- •Had previous spinal surgery, inferior limb length difference,
- •Could not exercise due to another injury/diagnosis,
- •Had neuromuscular, psychiatric, cardiovascular, respiratory insufficiency and mental disability
结局指标
主要结局
Cobb angle
时间窗: Change from pretreatment and 10 weeks after treatment.
The most accepted way of scoliosis evaluation is Cobb angle measurement performed on frontal plane x-ray. The Cobb angle is the curvature of the spine, and measuring it is essential for determining the severity of scoliosis, selecting the best course of action, and monitoring the progression or regression of cases following treatment. The Cobb angle measure as the vertically intersecting angle after determining the vertebrae above the apex and below the apex, which are the most tilted from the concave side of the curvature of the spine.
次要结局
- Pulmonary Functions Test- PEF (Peak expiratory flow)(Change from pretreatment and 10 weeks after treatment.)
- Scoliosis Research Society-22(Change from pretreatment and 10 weeks after treatment.)
- Angle of Trunk Rotation(Change from pretreatment and 10 weeks after treatment.)
- Pulmonary Functions Test- FEV1 (Forced expiratory volume in the first second)(Change from pretreatment and 10 weeks after treatment.)
- Pulmonary Functions Test-FVC (Forced vital capacity)(Change from pretreatment and 10 weeks after treatment.)
- Pulmonary Functions Test- FEV1/FVC(Change from pretreatment and 10 weeks after treatment.)
- Walter Reed Visual Assessment Scale(Change from pretreatment and 10 weeks after treatment.)
研究者
Eylem KÜÇÜK
Principal Investigator
Hacettepe University