Brain Computer Interface Training for Patients With Severe Upper Limb Paresis in the Subacute Phase After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
In this study, we want to examine the effect of a new treatment approach for patients with severe upper limb paresis in the subacute phase after stroke. Brain Computer Interface (BCI) driven functional electrical stimulation will be compared to conventional training.
详细描述
A randomized controlled pilot study will be conducted. Forty patients with severe UL paresis will be included. Patients with severe hemiparesis after stroke will be allocated to one of two treatment groups by a computerized randomization program. Patients in the intervention group will receive training with a BCI system paired with functional electrical stimulation and visual feedback (RecoveriX, gtec, Austria) as part of their rehabilitation. The targeted number of training sessions in the intervention group is 12. Patients in the control group will receive conventional upper limb training. All patients will receive other rehabilitation according to their needs.
Patients will be assessed by blinded raters before and after the intervention and 3 months post stroke. Main endpoint will be UL motor function assessed by Action Research Arm Test (ARAT) at 3 months post stroke. Other outcome measures comprise Fugl Meyer Motor Assessment and Functional Independence Measure. The patients and therapists' experience with this type of training will be evaluated with questionnaires and interviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All assessments will be done by assessors blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First ever or former stroke without UL motor residuals as confirmed by CT and / or MRI
- •15 days to 60 days (+/- 3) after stroke onset
- •Severe paresis or paralysis defined as < 13 on Action Research arm Test (ARAT)
- •Able to give informed consent
- •Able to comply with treatment protocol.
排除标准
- •Other conditions limiting functional use of the affected UL,
- •Psychiatric / behavioral conditions that interfere with compliance to the protocol, epilepsy
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: Upper limb function 90 days after stroke
Upper limb function on a scale of 0 - 57 (best)
次要结局
- Fugl-Meyer Assessment (UL)(Upper limb impairment 90 days after stroke)
- Functional Independence Measure(Functional independence 90 days after stroke)