Deep Phenotyping of Upper Limb Sensori-motor Recovery in Asian Stroke Survivors: Concept, Development and Implementation of a Rehabilomics-driven Technology-assisted Data Platform
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment (FMA)
研究概览
简要总结
As Singapore's population is aging rapidly, the incidence rate of stroke has been increasing in the past years. Rehabilitation is essential for the resumption of daily activities, and with the appropriate care, it is possible for stroke-survivors to regain most of their functions.
Hence, this study aims to better understand upper limb recovery covering different stages post-stroke in a representative cohort of Asian adults
详细描述
Stroke is a leading contributor to disability in Singapore, partially driven by a reduced ability to use the upper limb in their daily lives. Reduced upper limb use commonly results from a variety of impairments such as motor, sensory and cognitive impairments.
The aim of this longitudinal and observational study is to gather a rich multi-modal database on the time-course of upper limb recovery in a representative cohort after stroke and characterise the relationship between upper limb recovery, common post-stroke impairments and quality of life.
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
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke confirmed by neurologists, neurosurgeons and brain imaging (CT, CT angiogram, MRI, MR angiogram)
- •First ever confirmed stroke
- •Asian ethnicity
- •Age 21-90 years
- •Montreal Cognitive Assessment (MOCA) scores 21/30 and above
- •Admission to rehabilitation ward is within 8 weeks of stroke onset
排除标准
- •Recurrent stroke or transient ischaemic attack (TIA)
- •Upper limb impairment not related to stroke: e.g., subarachnoid haemorrhage, traumatic brain injury or brain tumours
- •Bilateral upper limb impairment.
- •Uncontrolled medical conditions such as hypertension, hypotension, diabetes mellitus, unstable angina, cardiac failure or sepsis will be excluded.
- •Active fractures or arthritis of upper limb joints/bones
- •Visual Analogue Scale (VAS) pain > 5/10
- •MOCA < 21/30
- •Severe behavioural disturbance or agitation or epilepsy or untreated depression
- •Life expectancy < 6 months
- •End organ failures on replacements (renal dialysis or renal replacement therapies)
- •Minimally responsive or unresponsive awareness (vegetative) states
- •Pregnancy or lactation states
- •Admission to rehab ward later than 8 weeks post-stroke
- •(For TMS assessments only) History of epilepsy or seizures, or cranial surgeries, or have metal implants in body or head, or have implanted electronics, or have metallic valve, or skull fracture or brain injury, or head or brain surgeries.
结局指标
主要结局
Fugl-Meyer Assessment (FMA)
时间窗: Inpatient: week 1 of admission
The FMA-UE is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, in patients with post-stroke hemiplegia.
次要结局
未报告次要终点