Experimentation of an Ankle Mobilization Device for the Rehabilitation of Patients With Acquired Brain Injuries.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Passive range of motion of ankle dorsi-plantarflexion
研究概览
简要总结
The proposed clinical investigation plan is a randomized controlled pivotal study with 2 parallel groups, has a total duration of two years. For the study, 30 pediatric patients suffering from acquired brain injury will be recruited at the Scientific institute Eugenio Medea.
The primary aim of this study is to assess the clinical benefit of using an ankle mobilization device for the rehabilitation of pediatric patients with acquired brain injuries, on its clinical performance and its risks, and on its safety.
The efficacy of the treatment will be evaluated in terms of ankle range of motion (primary outcome). The effects of the treatment on musculoskeletal plasticity will be studied using an isokinetic machine and functional magnetic resonance imaging will provide information on variations of reactivity in the motor cortical network. Ease of use, safety and usability of the device will also be evaluated.
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
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tetraplegic and hemiplegic acquired brain injury patients, within first month of injury.
- •Spastic syndrome (ankle joint Modified Ashworth Scale > 1).
排除标准
- •Pace maker or other contraindication to Magnetic Resonance Imaging scans.
- •Other serious comorbidity.
- •Behaviour and psychiatric disorders.
结局指标
主要结局
Passive range of motion of ankle dorsi-plantarflexion
时间窗: Change from baseline after 4 weeks of treatment
Measured with goniometer
次要结局
- Ankle joint stiffness(Change from baseline after 4 weeks of treatment)
- Cerebral activation(Change from baseline after 4 weeks of treatment)
- Medical Research Council (MRC) Scale for Muscle Strength(Change from baseline after 4 weeks of treatment)
- Time-Domain Near-Infrared Spectroscopy(Change from baseline after 4 weeks of treatment)