A Feasibility Study of Patient Self-Managed Brain-computer Interface Functional Electrical Stimulation (BCI-FES) Hand Therapy for Spinal Cord Injured Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Successful training for operation of BCI-FES system
研究概览
简要总结
This study aims to assess the feasibility of therapist-caregiver-patient training to use BCI and FES technology with a view to the inexpensive equipment eventually being used for home use by tetraplegic patients as a continuing rehabilitation method for sub-acute patients discharged from hospital.
详细描述
Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body. People with injury around the neck, suffer from tetraplegia, which affects function of both upper and lower limbs. Although these patients often have a caregiver, their main priority is to regain some upper limb function to increase independence. About half of patients with tetraplegia have an incomplete injury, i.e. have some sensation and control of muscles preserved. Natural recovery takes about a year and is typically accompanied by intense physical therapy while patients are in a hospital. Patients spend on average 4 months in hospital and, once they go home, there are very limited options for further therapy, in particular those living in rural areas.
This study will test the feasibility of patient and caregiver self-managed hand therapy based on the combination of brain computer interface (BCI) and functional electrical stimulation (FES). BCI is a system which consists of an electroencephalographic device (EEG), a computer and software that can analyse EEG while it is being recorded. To ensure that the knowledge stays within hospital, occupational therapists will first be trained who will then train patients and caregivers. The BCI-FES therapy is based on a previous clinical study with hospitalised patients, in which a researcher administered the therapy. In this study, a portable BCI-FES system will be used with an inexpensive consumer BCI, which is designed for non-professionals. The primary objective is to assess whether it is feasible for caregivers and patients to learn to operate the portable BCI-FES system on their own within 5 training sessions. The secondary objectives are to collect feedback from patients and therapists of their views via semi-structured interviews and questionnaires; to assess how stable the system parameters (EEG parameters, electrode location, FES stimulation parameters)are over time; to assess whether there is any functional and neurological recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •being within a year post-injury
- •has a caregiver willing to commit their time to the study
- •normal or corrected to normal vision
- •no history of brain disease or injury
- •incomplete injury at level C2 to C7
- •minimum computer literacy
- •understands spoken and written English
- •Occupational therapists
- •already has experience in providing occupational therapy to spinal cord injured people
- •familiar with using FES on patients
- •able and willing to commit time to the study
- •minimum computer literacy
- •possess mobile phone with a camera or are allowed to use patient's mobile phone with a camera for taking photos of the experimental setup (to remind themselves)
- •understands spoken and written English
排除标准
- •presence of neurological problem which may distort brain signal recording (e.g. epilepsy, Parkinson's disease, multiple sclerosis)
- •presence of cognitive impairments which would prevent patients or caregivers from understanding the task
- •inability to sit for 2 hours
- •general poor health due to secondary consequences of injury
- •any condition that would be contraindicative of using FES (pacemakers, sensitive skin/sores over areas where electrodes should be applied, pregnancy)
- •Occupational therapists
- •unable to commit sufficient time to the study
- •cannot learn to setup BCI-FES within 30 min within 4 hourly training sessions
- •cannot be present for all five therapy sessions
结局指标
主要结局
Successful training for operation of BCI-FES system
时间窗: 2 months
Number of times patients/caregivers successfully operate BCI-FES system within 30 min
次要结局
- System reliability(2 months)
- Time taken to use system(2 months)
- NASA task load index(2 months)
- Psychological Effect of Assistive Devices(2 months)
- Quebec User Evaluation of Satisfaction with Assistive Technology(2 months)
- Grip strength(Baseline and 2 months)
- Hand range of motion(Baseline and 2 months)