The Effect of a New-designed Modular Adaptive Seating System on Coronal and Sagittal Balance of the Spine and Pelvic Obliquity in Children With Nonambulatory Cerebral Palsy and Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Sagittal Balance
研究概览
简要总结
The effect of a modular seating system on coronal and sagittal balance of the spine and pelvic obliquity in children with non-ambulatory (Gross Motor Function Classification System Level IV-V) and scoliosis
The hypothesis in our study is; a modular adaptive seating system prevents the progression of spinal curvature and Reimer's maturation index, improves the sagittal balance of the spine and pelvic obliquity.
详细描述
Aim: The aim of this study was to evaluate the effect of a modular adaptive seating system and exercise therapy for scoliosis on the progression of spinal curvature, spinal sagittal balance and pelvic obliquity in children aged 6 to 15 years with cerebral palsy (Gross Motor Function Classification System (GMFCS) level IV-V) and scoliosis.
Materials and methods
A prospective, randomized and controlled, single-blind study was performed on 29 patients with cerebral palsy(CP). Patients were randomized into two groups. Both groups were given scoliosis home exercise program at least three days a week and 10 repetitions for each exercise in a day. In the first group, a modular adaptive seating system used for at least four hours in a day with exercise program for scoliosis. This seating system includes a sitting elevation that corrects the pelvic obliquity, the hip block that prevents the sliding from the sitting floor and a body support unit that provides the alignment of the spine and controls of the body. Cobb angle, pelvic obliquity, sagittal spino-pelvic parameters (thoracic kyphosis angle (TK), lumbar lordosis angle (LL), sagittal vertical axis (SVA), pelvic tilt (PT), pelvic incidence (PI), sacral slop (SS)) and Reimer's migration index (RMI) measurements were evaluated by Surgimap® software at the before and 3 months after treatment.
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)
盲法说明
In our clinical study, the person who performed radiographic evaluations before and after treatment did not know about the treatments received by the participants.
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the participant 6 to 15 years of age during inclusion
- •the participant is diagnosed as cerebral palsy by a specialist
- •the participant's Cobb angle is between 10-40 degrees. (Cobb angle above 40 degrees and patients whose parents have not accepted the operation)
- •There is no history of operation due to scoliosis or the decision of the operation has not been accepted by the patients and their parents
- •the participant is Gross Motor Function Classification System Level 4 or 5
- •Lack of contracture to prevent sitting in the lower extremity
- •Parents agree to participate in the intensive therapy program and stop the therapeutic interventions for scoliosis and lower extremities during the 3-month follow-up period
排除标准
- •Having a history of operation due to scoliosis
- •The deformity in the spine is rigid
- •If the curvature measured in the spine is less than 10 degrees or more than 40 degrees in the patients whose operation decision is accepted by the family
- •Having a seating modification applied at least 1 year before being included in the study
- •Having a spasticity and contracture to prevent sitting in the hip and knee joint
- •Having a pressure ulcer to prevent the patient from sitting
- •the participant has comorbidity that is not related about cerebral palsy
- •Having epileptic seizures not controlled
- •Having bone operations for hip joints
结局指标
主要结局
Sagittal Balance
时间窗: 12 weeks
sagittal balance of the spine is the posture of the spine on the sagittal plane
Cobb Angle
时间窗: 12 weeks
cobb angle shows the curvature of the spine in the coronal plane
Pelvic Obliquity
时间窗: 12 weeks
pelvic obliquity is posture of pelvis in relation to the ground
次要结局
- Reimer's Migration Index (RMI)(12 weeks)
研究者
Merve Damla Korkmaz
Assistant doctor
Istanbul University