Gait Analysis and Degenerative Spine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from baseline in gait parameter - step length (m) - at 3 months
研究概览
简要总结
The goal of this observational study is to analyse the biomechanics of a degenerative spinal disease. The main questions it aims to answer are:
- What are the biomechanical variables affected by the disease
- How they evolve with disease progression and treatment
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 50 and 85 years
- •Diagnosis of spinal disease by clinical and imagiological criteria
- •More than 3 months duration of disease
- •Ability to give consent
- •Fluent portuguese speaker
排除标准
- •Previous spine surgery
- •Spinal instability
- •Neurological disease that might interfere with walking
- •Known orthopedic conditions that causes significant gait impairment
- •Dementia or development disorder with cognitive impairment
- •Inability to give consent
结局指标
主要结局
Change from baseline in gait parameter - step length (m) - at 3 months
时间窗: 3 months
The change will be defined by a 10% increase in step length (meters) at 3 months from baseline assessment.
Change from baseline in gait parameter - step length (m) - at 12 months
时间窗: 12 months
The change will be defined by a 10% increase in step length (meters) at 12 months from baseline assessment.
Change from baseline in gait parameter - speed (m/s) - at 3 months
时间窗: 3 months
The change will be defined by a 10% increase in speed (meters/second) at 3 months from baseline assessment.
Change from baseline in gait parameter - step length (m) - at 6 months
时间窗: 6 months
The change will be defined by a 10% increase in step length (meters) at 6 months from baseline assessment.
Change from baseline in gait parameter - speed (m/s) - at 6 months
时间窗: 6 months
The change will be defined by a 10% increase in speed (meters/second) at 6 months from baseline assessment.
Change from baseline in gait parameter - speed (m/s) - at 12 months
时间窗: 12 months
The change will be defined by a 10% increase in speed (meters/second) at 12 months from baseline assessment.
Change from baseline in gait parameter - step width (m) - at 3 months
时间窗: 3 months
The change will be defined by a 10% decrease in step width (meters) at 3 months from baseline assessment.
Change from baseline in gait parameter - step width (m) - at 6 months
时间窗: 6 months
The change will be defined by a 10% decrease in step width (meters) at 6 months from baseline assessment.
Change from baseline in gait parameter - step width (m) - at 12 months
时间窗: 12 months
The change will be defined by a 10% decrease in step width (meters) at 12 months from baseline assessment.
次要结局
- Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 6 months(6 months)
- Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 6 months(6 months)
- Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 6 months(6 months)
- Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 3 months(3 months)
- Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 12 months(12 months)
- Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 3 months(3 months)
- Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 12 months(12 months)
- Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 12 months(12 months)
- Change from baseline in disability as measured by the Core Outcome Measures Index (COMI) at 3 months(3 months)
- Change from baseline in Back Pain as measured by the Numeric Pain Rating Scale (NPRS) at 12 months(12 months)
- Change from baseline in Quality of Life as measured by the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) at 6 months(6 months)
- Change from baseline in disability as measured by the Oswestry Disability Index (ODI) at 3 months(3 months)