Analysis of Postural Transitions in Subjects Affected by Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change of execution velocity of Postural Transfers
研究概览
简要总结
This observational trial aims to evaluate the effect of Rehabilitation on Postural Transfers (PTs) in subjects affected by Parkinson Disease. The PTs are evaluated by an inertial sensor (a device composed by an accelerometer, a gyroscope and a magnetometer) attached to the subjects. The data obtained by the inertial sensor are kinematic (e.g. acceleration and angular speed) and spatiotemporal parameters (e.g. time to completion and velocity). Additional clinical evaluations are carried out at the beginning and end of the rehabilitative intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Idiopathic Parkinson's Disease;
- •Subjects should be in a positive therapeutic window or in the ON phase during the evaluations;
- •Subjects must be able to walk at least 10 meters independently with or without any walking aid
排除标准
- •Non-clinically stable subjects;
- •Subjects in OFF phase during the evaluations;
- •Other neurological conditions (e.g. stroke, peripheral neuropathies, etc.);
- •Other pathologies that can negatively influence the subject's walking ability (e.g. surgery at the lower limbs in the previous 6 months, important deformities at the lower limbs, etc.)
结局指标
主要结局
Change of execution velocity of Postural Transfers
时间窗: Change from Baseline at 10 weeks
The execution velocity is measured via an inertial measurement unit attached to the back of the patient. Specifically the velocity are measured as the Root Mean Square of gyroscope signal.
Change of antero-posterior acceleration during Postural Transfers execution
时间窗: Change from Baseline at 10 weeks
The antero-posterior acceleration is measured via an inertial measurement unit attached to the back of the patient.
Change of superior-inferior acceleration during Postural Transfers execution
时间窗: Change from Baseline at 10 weeks
The superior inferior acceleration is measured via an inertial measurement unit attached to the back of the patient.
Change in execution time of Postural Transfers
时间窗: Change from Baseline at 10 weeks
The execution time is measured via an inertial measurement unit attached to the back of the patient
次要结局
- Change in 10 meter walking test(Change from baseline at 10 weeks)
- Change in Time Up and Go Test(Change from baseline at 10 weeks)
- Change in Berg Balance Scale Score(Change from baseline at 10 weeks)
- Change in Short-Form 12 score(Change from baseline at 10 weeks)