Wristbot: A Novel Device for the Assessment of Proprioceptive Deficits After Stroke.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- standardised somatosensory deficit index
研究概览
简要总结
The WristBot constitutes a comprehensive, integrated robotic system for the early diagnosis and rehabilitation of sensory and fine motor dysfunction to neurological or orthopedic disease.
详细描述
The WristBot constitutes a comprehensive, integrated robotic system for the early diagnosis and rehabilitation of sensory and fine motor dysfunction to neurological or orthopedic disease. It has been validated in three clinical trials, including orthopaedic patients, Parkinsons disease and 9 chronic stroke patients. Its unique feature uses adaptive, progressive robot-aided therapy to achieve intensive, task specific wrist movements.
In the context of the proposed project we will target the stroke population. Integration refers here to the system's ability to perform the assessment of proprioceptive status and proprioceptive training in a single device. The scope of the current project is investigating the efficacy of the proprioceptive assessment of the WristBot and correlating the result throughout the rehabilitation protocol. The proposed technology comprises a hardware device with four motors that can apply torques to the human wrist about its three degrees of freedom (i.e. axes of rotation: wrist flexion/extension,abduction/adduction and forearm pronation/supination). This allows for guided and controlled movements of the wrist by delivering assistive, resistive, perturbation or no forces (patient actively moves the wrist). It contains a set of specialized software modules that a) allow for the objective, psychophysical assessment of sensory dysfunction in patients, and b) provide specialized training modules designed to improve sensory and motor functions of the wrist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First clinical stroke (ischaemic or haemorrhagic) diagnosed by brain imaging CT or MRI
- •Age 21 years to 85 years, both males and females.
- •< 90 days of stroke on admission to rehabilitation
- •Presence of either motor and /or sensory deficit detected by clinical examination.
- •Ability to understand simple instructions.
- •Ability to give own consent.
- •Ability to sit supported in a chair for 60 minutes with appropriate rest breaks.
排除标准
- •Non stroke -related causes of motor/sensory deficits
- •Tetraplegia or tetraparesis
- •Known diagnosis of cervical myelopathy, lower motor neuron weakness (Post polio, brachial plexopathy, peripheral neuropathy (Diabetic, carpel tunnel syndrome, B12 deficiency)
- •Concomitant orthopaedic condition limiting wrist range of motion: active arm/wrist fractures, fixed contractures of the wrist joint, wrist joint arthritis, wrist fusion.
- •Arm or wrist joint pain (Visual Analogue scale VAS >5/10) or instability
- •Severe hemispatial neglect.
- •Significant wrist spasticity with modified Ashworth Scale score 2 and above.
- •Life expectancy <6 months, end stage renal or liver disease, terminal cancer.
- •Pregnancy and lactation in female patients.
- •Postural hypotension on sitting up
- •Active skin conditions over wrist joint area which could be worsened by robotic fit (e.g. severe eczema, burns)
结局指标
主要结局
standardised somatosensory deficit index
时间窗: 2 years
Sensory assessment of upper limb
Visual Analogue scale
时间窗: 2 years
Scale to assess pain
Modified Ashworth Scale
时间窗: 2 years
Test of muscle spasticity for upper limb
Fugyl Meyer assessment motor assessment score (FMA 0-66)
时间窗: 2 years
To assess motor impairment of affected upper limb
Wolf Motor Function Test for affected limb (WMFT),
时间窗: 2 years
To assess motor impairment of affected upper limb
Nine hole peg test (in seconds)
时间窗: 2 years
brief, standardized, quantitative test of upper extremity function
Functional Independence Measure
时间窗: 2 years
Test of upper limb function
次要结局
未报告次要终点