Hand Motor Recovery Using a EMG-biofeedback in Stroke Rehabilitation: a Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Upper Extremity (FMA-UE)
研究概览
简要总结
Recovery of upper limb and hand gestures is fundamental for autonomy restoration after stroke. Innovative technologies are a valid support for the delivery of rehabilitation treatments. Embedding surface electromyographic (sEMG) into wearable devices, allows the customisation of rehabilitation exercises, based on the clinical profile of each patient.
详细描述
The aims of this study are to determine safety and feasibility of a prototype EMG-control wearable device (REMO) and to individualise clinical features of stroke survivors able to control the EMG armband targeted to hand rehabilitation.
The device REMO consists in an armband composed by 8 bipolar electrodes able to record and process the electromyography of forearm muscles. The patterns of muscle activations are classified and used to perform EMG-biofeedback exercises in stroke rehabilitation training. The device is developed by clinicians of IRCCS San Camillo Hospital and spin-off Morecognition Srl.
A total of 100 stroke patients patients has been recruited. They are clinically assessed and then tested on the ability to control the sEMG wearable device. The test is composed of 10 hand and fingers gestures to be performed with the paretic hand. Baseline and activation sEMG signals are recorded and compared for each movement. Three conditions representing absent, partial or full control of the device are defined and logistic multivarialbes regression models are used to identify clinical features describing the group each patient belongs to. Clinical cut-off for each strata is identified by odds ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Single ischemic or haemorrhagic stroke;
- •Score lower than 100 out of a total of 126 at the Functional Independence Measure (FIM) scale
排除标准
- •Untreated epilepsy;
- •Major depressive disorder;
- •Fractures;
- •Traumatic Brain Injurj;
- •Severe Ideomotor Apraxia;
- •Severe Neglect;
- •Severe impairment of verbal comprehension.
结局指标
主要结局
Fugl-Meyer Upper Extremity (FMA-UE)
时间窗: within 1 week from enrolment.
Motor function of the upper limb is measured by means of the Fugl-Meyer Scale. There are 3 values: 0 (severe impairment), 1 (moderate impairiment), 2 (preserved function)
次要结局
- Fugl-Meyer - sensation(within 1 week from enrolment.)
- Fugl-Meyer - pain and Range of Motion(within 1 week from enrolment.)
- Box and Blocks Test (BBT)(within 1 week from enrolment.)
- Reaching Performance Scale (RPS)(within 1 week from enrolment.)
- Modified Ashworth Scale (MAS)(within 1 week from enrolment.)
- Nine Hole Pegboard Test (NHPT)(within 1 week from enrolment.)
- Functional Independence Measure scale (FIM)(within 1 week from enrolment.)
- Number of movements controlled by EMG-biofeedback device(within 1 week from enrolment.)
研究者
Andrea Turolla
Laboratory of Rehabilitation Technologies
IRCCS San Camillo, Venezia, Italy