Modulation of Sagittal Spinal Geometry in Children With Cerebral Palsy: Randomized Controlled Trial
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
- Change from baseline Thoracic kyphotic angle at 3 months
研究概览
简要总结
The aim of this study will be to evaluate the the effect of Thera Togs soft orthotic undergarment on modulation of the spinal geometry and mobility in sagittal plan in children with spastic diplegic cerebral palsy.
详细描述
Forty children with spastic diplegic CP will be assigned and randomly distributed into two equall groups (A& B). Control group (A) will receive conventional rehabilitation program for postural correction 2 hours/3 sessions' weekly/3 successive months. Study group (B) will receive conventional rehabilitation protocol as in group (A) plus wearing TheraTogs soft orthotic undergarment. Children evaluation will be carried out before and after the intervention programs to assess postural deviations using the Formetric system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a definite diagnosis of spastic diplegia obtained from medical files or personal physicians and supported by magnetic resonance images (MRIs).
- •Their weight should be less than 40 kg.
- •The degree of spasticity in the affected lower extremity will ranged between grades (1, 1+&2) according to Modified Ashworth Scale.
- •The levels of gross motor function will be selected at level II according to Gross Motor Function Classification System.
- •The children will be included have the ability to stand alone for five minutes.
- •Children should be able to understand and follow instructions.
- •The degree of the spinal kyphosis ,for all participated children , in sagittal plane should be not more than 55° as Kyphosis above 55° is considered as fixed hyper-kyphosis while
排除标准
- •Children with GMFCS levels III, IV, and V or use any assistive mobility devices
- •Children suffering from allergic problems in their skin.
- •Children with visual, auditory or cognitive deficits.
- •Fixed and significant deformities of the lower limb and spine.
- •Children with surgical interference for the lower limb and spine within the previous 2 years.
- •Children with seizures.
- •Children with fixed hyper-kyphosis (kyphotic angle is more than 55°).
- •Children who used any medications (e.g., steroids) that affect growth or body composition.
结局指标
主要结局
Change from baseline Thoracic kyphotic angle at 3 months
时间窗: Baseline and 3 months post-intervention
Thoracic kyphotic angle will be calculated from the sagittal profile by Foremetric system.
Change from baseline lumber lordotic angle at 3 months
时间窗: Baseline and 3 months post-intervention
Lumber lordotic angle will be calculated from the sagittal profile by Foremetric system.
次要结局
未报告次要终点
研究者
Shamekh Mohamed El-Shamy
Professor
Umm Al-Qura University