Efficacy and Neurophysiological Correlates of a Bilateral Robotic Treatment for the Upper Limbs in Patients With Chronic Stroke Outcomes
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Changes in the Fugl-Meyer for the upper limb functional scale (UEFM)
概览
简要总结
The goal of this clinical trial is to evaluate how manual dominance influences the effectiveness of bilateral robotic treatment in right-handed patients with chronic stroke.
Researchers will compare the outcome of a bilateral robotic treatment for the upper limbs in left vs right hemisphere lesions following stroke.
Participants will:
- perform a bilateral robotic treatment for the upper limb (15 sessions in three weeks) followed by 20-minutes standard manual rehabilitative sessions
- be evaluated before and after treatment with clinical scales, resting- state EEG and kinematic measurements
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 18 and 80 years, of either sex
- •Subjects able to understand and provide, or have provided on their behalf, informed consent
- •History of a single unilateral ischemic or hemorrhagic cerebrovascular event in the chronic phase (\> 6 months)
- •Subjects with mild to moderate functional impairment of the right or left upper limb (ability to perform antigravity active movements)
排除标准
- •Subjects with cognitive deficits that impair understanding of the required tasks (MMSE score corrected for age and education \< 24/30)
- •Subjects with severe visual deficits
- •Subjects with upper limb spasticity preventing the use of robotic devices (spasticity measured using the Modified Ashworth Scale \> 3)
- •Inability or unwillingness to provide informed consent
- •Left-handed subjects
研究组 & 干预措施
Right hemisphere lesion group
The stroke patients with right hemisphere lesion will be performing the bilateral robotic treatment with the exoskeleton ALEx-RS followed by a standard manual treatment
干预措施: Bilateral robotic treatment for the upper limbs (Device)
Left hemisphere lesion group
The stroke patients with left hemisphere lesion will be performing the bilateral robotic treatment with the exoskeleton ALEx-RS followed by a standard manual treatment
干预措施: Bilateral robotic treatment for the upper limbs (Device)
Left hemisphere lesion group
The stroke patients with left hemisphere lesion will be performing the bilateral robotic treatment with the exoskeleton ALEx-RS followed by a standard manual treatment
干预措施: Standard physiotherapy (Behavioral)
Right hemisphere lesion group
The stroke patients with right hemisphere lesion will be performing the bilateral robotic treatment with the exoskeleton ALEx-RS followed by a standard manual treatment
干预措施: Standard physiotherapy (Behavioral)
结局指标
主要结局
Changes in the Fugl-Meyer for the upper limb functional scale (UEFM)
时间窗: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
The scale ranges from 0 to 66, with higher scores indicating better performance
次要结局
- Changes in weighted Phase Lag Index (wPLI) cortico-cortical brain connectivity (EEG)(From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0)
- Changes in the Visual Analogue Scale (VAS)(From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0)
- Changes in the modified Ashworth scale (MAS)(From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0)
- Changes in the Bimanual Activity Test scale (BAT)(From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0)
- Changes in the Stroke Impact Scale (SIS)(From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0)
- Changes in the Quick Dash scale(From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0)
- Changes in weighted Symbolic Mutual Information (wSMI) cortico-cortical brain connectivity (EEG)(From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0)
- Changes in muscular synergies (EMG)(From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0)
- Changes in kinematic movement smoothness (SPARC)(From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0)
研究者
Carmelo Chisari
Professor
University of Pisa