sEMG Based-Rehabilitation of Hand and Fingers After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Change at Box and Block Test (BBT)
研究概览
简要总结
The major issue for a person who has suffered a stroke is the severe impairment affecting the hand and the high risk to have a poor recovery associated. Innovative approaches are needed in the next future, translating recent advances from neuro-engineering, into feasible devices for rehabilitation care. The FP7-EU project MYOSENS aims to translate known motor control logic from sEMG prosthetic control, to rehabilitation robotics. The target is to promote the closing of sensory-motor loop on the basis of intention to move, as detected from residual sEMG (i.e. Extensor Digitorum Communis, Flexor Digitorum Profundus).
详细描述
The objectives of this pilot study are:
- to assess whether a clinical and kinematic effect might be induced providing a closed-loop control by sEMG signal for robot (i.e. Amadeo ®) assisted therapy of hand function
- to determine safety and feasibility of including robotic therapy into daily rehabilitation programs after stroke.
A total of 20 patients has been recruited, all of them received on daily basis 1 hour of robot therapy in adjunction to 1 hour of standard therapy. Overall the hour of robotic therapy include both subject preparation (15 minutes to place surface electrodes on the forearm and set the right position of sitting and upper limb) and delivery of exercises. The treatment protocol includes passive and active training of flexion and extension movements of the fingers. The passive part lasts 5 minutes, while the active one provides 25 total minutes divided into 5 exercises. The robot therapy lasts 15 consecutive sessions, 5 times a week, for 3 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from first stroke, ischemic and/or hemorrhagic
- •Score between 1 and 3 at the upper-limb sub-item of the Italian version of the National Institute of Health Stroke Scale, IT-NIHSS (Pezzella et al. 2009)
- •Score lower than 100 out of a total of 126 at the Functional Independence Measure (FIM) scale.
- •Less than 45 cubes carried in one minute whit the affected hand at the Box and Bocks Test.
排除标准
- •Non-stabilized fractures
- •Diagnosis of depression
- •Traumatic brain Injury
- •Untreated or drug resistant seizures.
- •Severe ideomotor apraxia
- •Severe neglect
- •Patients participating in other rehabilitation treatments for the upper-limb (e.g. virtual reality treatment, motor imagery).
研究组 & 干预措施
Robot group
Receive 1 hour of AMADEO (robot-assisted therapy) for the hand and 1 hour of daily standard rehabilitation therapy
干预措施: AMADEO (Device)
结局指标
主要结局
Change at Box and Block Test (BBT)
时间窗: Before treatment, then 3 weeks after
Hand dexterity is measured by means of the BBT. The patient has to carry as much cubes as possible, one by one, from a container to another one in one minute. The test is performed with both hands.
次要结局
- Change at Modified Ashworth Scale (MAS)(Before treatment, then 3 weeks after)
- Change at Functional Independence Measure scale (FIM)(Before treatment, then 3 weeks after)
- Change at Fugl-Meyer Assessment Scale: Upper Extremity Motor Function (F-M UE)(Before treatment, then 3 weeks after)
- Change at Nine Hole Pegboard Test (NHPT)(Before treatment, then 3 weeks after)
- Change at Reaching Performance Scale (RPS)(Before treatment, then 3 weeks after)
研究者
Andrea Turolla
Laboratory Head
IRCCS San Camillo, Venezia, Italy