A Pilot Study of Active, Robot-assisted Therapy for Shoulder Rehabilitation After Stroke, Using Myoelectric Signals
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Fugl-Meyer Assessment scale - Upper Extremity (FMA-UE)
研究概览
简要总结
The aim of this study is to assess the clinical effectiveness of the RehaARM-robot and to determine the feasibility of including robotic therapy in daily rehabilitation programmes, after stroke. Additionally, we aim to investigate the acceptance of this intervention from patients and therapists. A total of 10 patients will be recruited in this study, all the patients will receive 1 hour of standard therapy together with 45 min of robot therapy every day. The robot therapy will last 45 minutes, for 15 consecutive days within a maximum period of four weeks. Additional 15 minutes are required for placing surface electrodes on the shoulder and patient preparation. The study will include passive and active shoulder training of four movements: Horizontal abduction/adduction, abduction/adduction, internal/external rotation and flexion/extension. The passive part lasts 10 minutes and the active part 35 minutes.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients suffering from stroke, ischemic and / or hemorrhagic
- •Stroke in the left hemisphere
- •Score between 1 and 3 in the upper-limb sub-item of the Italian version of the National Institute of Health Stroke Scale (IT-NIHSS) (Pezzella et al. 2009)
- •Score of the Functional Independence Measure (FIM) scale (Keith et al., 1987) less than 100 out of a total of
- •This scale is used as a reference to indicate the degree of autonomy in carrying out activities of daily living (ADLs)
- •Score of the upper-limb Fugl-Meyer scale (FMA) (Fugl-Meyer et al., 1975) less than
- •This scale measures the residual motor function of a person after stroke
排除标准
- •Non-stabilized fractures
- •Diagnosis of depression
- •Traumatic brain Injury
- •Pharmacologically uncontrolled epilepsy
- •Ideomotor apraxia
- •Mini Mental State Examination (MMSE) score <20/30
- •Severe impairment of verbal comprehension, defined by a score in the Token Test (Tau points<58/78)
- •Patients participating in other rehabilitation treatments for the upper-limb (e.g. virtual reality treatment, motor imagery, etc)
结局指标
主要结局
Fugl-Meyer Assessment scale - Upper Extremity (FMA-UE)
时间窗: 3 weeks (15 sessions)
Motor function of the upper limb is measured by means of the Upper Extremity Motor Assessment of the Fugl-Meyer Assessment Scale.
次要结局
- Functional Independence Measure (FIM)(3 weeks (15 sessions))
- Reaching Performance Scale (RPS)(3 weeks (15 sessions))
- Modified Ashworth Scale (MAS) of five muscles(3 weeks (15 sessions))
- Nine Hole Pegboard Test (NHPT)(3 weeks (15 sessions))
研究者
Andrea Turolla
Head of Laboratory of Kinematics and Robotics
IRCCS San Camillo, Venezia, Italy