Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Joint Stiffness of affected upper limb joint
研究概览
简要总结
The proposed clinical investigation plan is a pivotal controlled study with two parallel groups, has a total duration of 12 months and involves the recruitment of 34 pediatric patients suffering from acquired brain injury.
The primary objective of the clinical study is to evaluate the improvement of joint stiffness through the use of sensorized pseudoelastic orthoses for the rehabilitation of pediatric patients with acquired brain injury.
The effectiveness of the treatment in terms of joint stiffness (primary outcome) will be assessed and the effect of the treatment will be quantified with clinical evaluation scales and instrumental measurements by means of an optoelectronic system and isokinetic machine. The tolerability and acceptability of the device will also be checked.
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 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Quadriplegia or acquired hemiplegia.
- •Age 6-20 years.
- •Dystonic, dyskinetic, spastic.
- •Chronic phase patients (> 1 year post event).
- •Spastic syndrome with Ashworth Score (AS) for the limb of interest>
- •Collaborative.
排除标准
- •Fixed limitations of the joint.
- •Joint pain.
- •Skin allergies.
- •Behavioral and psychiatric disorders (eg, emotional problems, anxiety, panic attacks).
结局指标
主要结局
Joint Stiffness of affected upper limb joint
时间窗: After 4 weeks of treatment
Quantitative measure performed by means of an isokinetic machine (Unit of measure: Nm/°). Changes in joint stiffness following the use of new customized devices during a rehabilitation treatment period. Lower stiffness is better.
次要结局
- Melbourne Upper Limb Assessment 2(After 4 weeks of treatment)
- Range of motion of target joint during a pointing-forward task(After 4 weeks of treatment)
- Quality of Upper Extremity Skills Test(After 4 weeks of treatment)
- Active range of motion(After 4 weeks of treatment)
- Passive range of motion(After 4 weeks of treatment)
- Modified Ashworth Scale(After 4 weeks of treatment)