Neuro-rehabilitation of Upper Limb Stroke Patients Through Motor Resonance and Mirror Neurons
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Motion Capture (MOCAP) recordings
研究概览
简要总结
The purpose of this study is to assess the changes in physiological parameters and clinical scales resulting from treatment with AOT (action observation training) in subjects with subacute stroke. Furthermore, this study assess the perception of applicability and satisfaction degree for this kind of treatments.
详细描述
After being informed about the study, all patients give written informed consent and will undergo a 1-week screening period to determine eligibility for study entry. Patient who meet the eligibility requirements will be given clinical and instrumental assessments before the start of treatment (T0) after 3 weeks (T1), at the end of the treatment (T2) and after 6 months (T3). A training program of 4 weeks including 250 videos of every day actions has been developed. Videos includes transitive and intransitive actions. Each week has a five day program, each day is divided in three sessions, in each session there are observation and imitation and attentional questions. AOT is always performed in conjunction with the conventional rehabilitation program.
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
- •Should had experienced first ever ischemic or haemorrhagic stroke
- •Fugl-Meyer Assessment < 55
- •normal or corrected to normal visual acuity
排除标准
- •presence of severe neuropsychological disorders
- •medical conditions likely to interfere with the ability to safely complete the study protocol
- •pain in the upper limb assessed with the Visual Analogue Scale (VAS)> 7
- •intracranial metal implants
- •history of seizures or epilepsy
- •severe cardiopulmonary, renal, and hepatic diseases
- •pregnancy
结局指标
主要结局
Motion Capture (MOCAP) recordings
时间窗: Up to 1 month
Kinematic data of trunk and affected hand will be recorded during subject imitations and will be analysed to assess any improvements.
Change in Oxford Cognitive Screen between two time points
时间窗: Baseline and week 4
is a stroke-specific cognitive screen
Change in Box and Block Test between four time points
时间窗: Baseline, week 3, week 4,after 6 months
To assess unilateral gross manual dexterity
Change in Modified Ashworth Scale between four time points
时间窗: Baseline, week 3, week 4,after 6 months
To measure spasticity. It consists of a 5-point nominal scale using subjective clinical assessments of tone ranging from 0 - 'No increases in tone' to 4 - 'Limb rigid in flexion or extension \[abduction/adduction\]'. An additional grade is added (1+) for the MAS to indicate resistance in the movement.
Electroencephalography power in alpha band
时间窗: Up to 1 month
EEG data will be recorded to test presence of particular changes in brain activity in during AOT training. In particular plasticity and mu rhythm desynchronization will be investigated.
Change in Fugl-Meyer Assessment Upper Extremity between four time points
时间窗: Baseline, week 3, week 4, after 6 months
Scale that assess the sensorimotor impairment in individuals who have had stroke.
Change in Barthel Index between four time points
时间窗: Baseline, week 3, week 4,after 6 months
Scale that measures disability or dependence in activities of daily living in stroke patients.
Change in Visual Analogue Scale between four time points
时间窗: Baseline , week 3, week 4,after 6 months
Scale that consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The length of the line is 10-cm. Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as their pain.
次要结局
- Applicability perception and satisfaction degree of the proposed treatment(At week 4)
研究者
Sofia Straudi
MD, PhD
University Hospital of Ferrara