Upper Limb Telerehabilitation Using Brain -Controlled Functional Electrical Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Evaluate the feasibility of the proposed system through the ability of participants to control the Tele BCI-FES
研究概览
简要总结
The study aims to identify whether stroke survivors can intentionally modulate their brain signals for controlling an FES device to produce arm movements for home based rehabilitation. The study also assess the participants acceptability of this new home-based rehabilitation.
详细描述
Movements of different parts of the body, including the arm, start when the brain produces specific electrical signals. Sometimes after a stroke, even though the person intends to move the arm, the arm will not move or will only move partly. The brain continues to produce electrical signals after stroke, but when the signals are weak the arm does not move. Brain-computer interface (BCI), is a method of utilising the brain signals to produce useful outputs via computers. One type of BCI is BCI Functional Electrical Stimulus (BCI-FES) which is a device that can detect these brain signals produced during the intention to move the weak arm after a stroke. It then uses these signals to trigger an electrical stimulator. The electrical stimulator then stimulates the muscles in the weak arm to produce the desired arm movement. Recent studies show that rehabilitation using this device has given better results when compared with conventional rehabilitation approaches. However, the BCI-FES devices currently available are bulky and participants need to come to the hospital or laboratory to receive the treatment. Our project aims to develop a BCI-FES device, called Tele BCI-FES that can be used at stroke participant's home. The investigators are using techniques like machine learning to make the Tele BCI-FES quick and simple to set up, easy to use and effective. This study aims to investigate if the proposed Tele BCI-FES device is a feasible and acceptable intervention for post-stroke rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Age 18 and above.
- •(2) Experienced an ischaemic or haemorrhagic stroke more than 6 months ago.
- •(3) Arm weakness interfering with activities of daily living.
- •(4) Fugl-Meyer score of upper limb<
- •(5) Caregiver is willing to assist with trial by helping to deliver intervention.
- •(6) Cognitive and language abilities to understand and participate in the study protocol.
- •(7) Can maintain sitting with or without support for 1 hour continuously.
- •(8) Able to give consent and understand instructions.
- •Exclusion criteria:
- •Cognitive impairment that would interfere with their ability to comply with the experimental protocol or provide informed consent;
- •Dermatological, rheumatologic or orthopaedic illnesses of the affected arm interfering with movement of the elbow;
- •Pre-existing severe systemic disorders like cardiovascular disease; active cancer or renal disease; end stage pulmonary or cardiovascular disease; psychiatric illness including severe alcohol or drug abuse
- •Inability to perform the baseline assessments;
- •Severe tactile hypersensitivity;
- •Participation in other, upper limb rehabilitation studies
- •Within 12 weeks of receiving Botulinum toxin injections;
- •History of epilepsy
- •Pace maker or any other implanted devices
- •Severe dystonia/spasm
排除标准
- 未提供
结局指标
主要结局
Evaluate the feasibility of the proposed system through the ability of participants to control the Tele BCI-FES
时间窗: within 10 minutes after experimental session
To evaluate whether the participants can effectively control FES using the developed remote BCI system (Success: the BCI accuracy of more than 70% in at least 7 out of 9 sessions).
Recruitment rate
时间窗: Pre-intervention
To measure the acceptability of the proposed rehabilitation
Evaluate the usability and acceptability of the proposed system based on the number of participants completing each TeleBCI-FES intervention session
时间窗: through study completion, an average of 5 weeks
Number of participants completing each TeleBCI-FES intervention session (Success: 7 participants completed 8 or more of 12 TeleBCI-FES sessions)
次要结局
- Modified Ashworth Scale(Pre-intervention and up to 5 weeks)
- Leeds Arm Spasticity Scale-reference(Baseline and up to 5 weeks)
- Numerical rating Scale (NRS)(Pre-intervention and up to 5 weeks)
- European Quality of List 5D-5L (EQ-5D-5L):(Pre-intervention and .up to 5 weeks)
- Medical Research Council grading(Pre-intervention and up to 5 weeks)
- Fugl-Meyer Assessment(Pre-intervention and up to 5 weeks)
- Action Research Arm Test(Pre-intervention and up to 5 weeks)
- Pittsburgh Participation in Rehabilitation scale(within 10 minutes after experimental session)