Multimodal EEG and NIRS-based BCI With Assistive Soft Robotics for Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Fugl-Meyer score of upper limb
研究概览
简要总结
One-third of patients who had stroke suffered persistent disabilities, and upper limb (UL) motor impairment is one of the main disabilities. Recent clinical studies had been conducted using non-invasive EEG-based BCI via motor imagery, for post-stroke rehabilitation, yielded motor improvement of 7.2 on the Fugl-Meyer Motor Assessment (FMA-UE)score in chronic stroke patients that is significantly better than standard care. However, all the stroke patients underwent the same "one-size-fits-all" treatment option involving all six different activities of daily living (ADL)-oriented tasks regardless of their impairment or ability.
Investigators hypothesize that precision personalized stroke rehabilitation intervention that is tailored to the patient hold more promise than a "one-size-fits-all" stroke rehabilitation strategy.
详细描述
- To address the "one-size-fits-all" stroke rehabilitation strategy, RRIS will develop an Ability data-driven personalized stroke rehabilitation based on the stroke patient's UL impairment and motor ability, by first matching 6 UL tasks in RRIS Ability Database with the 6 ADL tasks of the BCI-SR Intervention via similarity indices. A personalized subset of ADL tasks treatment options is then generated by a data-driven recommendation based on the patient's ability, movement pattern of the treatment option and the normative data from the RRIS Ability Database. A multi-modal BCI is proposed to perform EEG subject-specific calibration using Near-infrared spectroscopy, NIRS to ensure motor imagery compliance.
- stroke subjects with UL impairments (score 11-45 on the FMA-UE) will be recruited to undergo the UL tasks assessment at RRIS. They will then undergo the personalized stroke rehabilitation using the Multimodal EEG and NIRS-based BCI with Soft Robotic therapy for 1.5 hour over 6 weeks, 3 times a week. The effectiveness of the personalized stroke rehabilitation can then be retrospectively compared to the use of "one-size-fits-all" ADL tasks in the previous clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first ever stroke prior to clinical trial
- •Fugl-Meyer Assessment scale of upper extremity impairment of 11-45 out of a maximum score of 66
- •ability to give own consent
- •ability to pay attention and maintain supported sitting for 1.5 hours continuously
- •able to comprehend and follow commands
- •fulfils BCI resting brain states on initial screening
- •unilateral upper limb impairment
排除标准
- •recurrent stroke
- •inability to follow command and sit upright for 1.5 hours
- •hemi-spatial neglect
- •spasticity assessed by Modified Ashworth Scale more than 2/4
- •History of Epilepsy
- •Fixed contracture / deformity of finger joints
- •upper limb pain impeding movements with visual analogy scale > 4/10
- •Severe aphasia or cognitive impairment despite visual aids
- •other conditions ensuing upper limb weakness
- •poor skin conditions
- •skull defect that might affect EEG or NIRS reading
- •allergy to electrodes or adhesive gel
- •significant vision and hearing impairment affecting participation
- •Pregnant women
研究组 & 干预措施
MBCI-SR
BCI based robotic rehabilitation works by detecting the motor intent of the user from Electroencephalogram signals to drive rehabilitation assisted by the soft robotics gloves.
干预措施: MBCI-SR (Device)
结局指标
主要结局
Fugl-Meyer score of upper limb
时间窗: at week 24 (at 6 month post intervention)
a measure for upper extremity, movement coordination and reflex action.
Fugl-Meyer score of upper limb
时间窗: Baseline
a measure for upper extremity, movement coordination and reflex action.
Fugl-Meyer score of upper limb
时间窗: at week 4 (mid point)
a measure for upper extremity, movement coordination and reflex action.
Fugl-Meyer score of upper limb
时间窗: at week 6 (completion of intervention)
a measure for upper extremity, movement coordination and reflex action.
Fugl-Meyer score of upper limb
时间窗: at week 12 (at 3 month post intervention)
a measure for upper extremity, movement coordination and reflex action.
次要结局
- Action Research Arm Test(at week 24 ( at 6 months post intervention))
- Action Research Arm Test(Baseline)
- Action Research Arm Test(at week 12 (at 3 months post intervention))
研究者
Chloe Chung Lau Ha
Principal Physiotherapist
Tan Tock Seng Hospital