MOdularity for SEnsory Motor Control: Implications of Muscle Synergies in Motor Recovery After Stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 132
- 试验地点
- 3
- 主要终点
- Fugl-Meyer Assessment Scale - Upper Extremity (construct: upper limb motor function)
研究概览
简要总结
For this project the investigators ask, how the activation and organization of muscle synergies may be disrupted by brain lesions, and whether it is possible to modify synergy activations by means of specific therapies. Will be investigated whether there is a relationship between post-stroke cortical plasticity and changes in synergy activations due to a therapy.
详细描述
It has been widely recognized that neurorehabilitation can facilitate recovery of motor function after stroke. There has been increasing evidence suggesting that the execution of voluntary movement relies critically on the functional integration of the motor areas and the spinal circuitries. More precisely, it was suggested that the central nervous system may generate neural motor commands through a linear combination of spinal modules, each of which activates a group of muscles as a single unit (muscle synergy). The investigators hypothesize that descending motor cortical signals generate movements by combining and activating muscle synergies. With this background, the goal is to further improve the efficacy of rehabilitation utilizing knowledge on modular motor control. The investigators also seek to provide a better understanding of the links between brain activations and movements.
The project MO-SE has three aims, one primary and two secondary. The main primary aim is to test whether the use of virtual reality rehabilitation based therapies are superior in terms of clinical efficacy to conventional therapies (randomized clinica trial, RCT). The other two secondary aims of the project will be accomplished with further instrumental analysis in sub-samples of the group of patients enrolled for the RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
A simple random number sequence will be generated by a computer and the allocation concealment will be guaranteed using sequentially numbered, opaque sealed envelopes. The therapists responsible for randomization and allocation procedures will be independent of the blind therapists and medical doctors involved in patients' screening and treatment.
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
- •diagnosis of first stroke;
- •a score between 1 and 3 (included) at the upper limb sub-item on the Italian version of the National Institute of Health stroke scale (IT - NIHSS) (Pezzella et al., 2009)
- •a score higher than 6 out of 66 on the Fugl - Meyer upper extremity (F-M UE) scale (Fugl-Meyer et al., 1975).
排除标准
- •the presence of a moderate cognitive decline defined as a Mini Mental State Examination (Folstein et al., 1975) score < 20/30 points;
- •the finding of severe verbal comprehension deficit defined as a number of errors > 13 (Tau Points < 58/78) on the Token Test (Huber et al., 1984);
- •evidence of apraxia and visuospatial neglect interfering with upper arm movements and manipulation of simple objects in all the directions within the visual field, as assessed through neurological examination;
- •report in the patient's clinical history or evidence from the neurological examination of behavioural disturbances (i.e. delusions, aggressiveness and severe apathy/depression) that could affect compliance with the rehabilitation programs;
- •non stabilised fractures;
- •diagnosis of depression/delusion;
- •associated traumatic brain injury;
- •drug resistant epilepsy;
- •evidence of ideomotor apraxia;
- •evidence of visuospatial neglect;
- •severe impairment of verbal comprehension defined as a score higher than 13 errors on Token test (i.e. score<58 out of 78 Tau points).
结局指标
主要结局
Fugl-Meyer Assessment Scale - Upper Extremity (construct: upper limb motor function)
时间窗: 20 days
Scale range scores: 0 - 66 points. Total summed score is reported with higher values representing a better outcome.
次要结局
- Functional Independence Measure (FIM) (construct: measure for independence in the activities of daily living - ADLs)(20 days)
- Fugl-Meyer Assessment Scale - Sensory Function (construct: measure of residual sensory function in upper and lower limbs affected by paresis)(20 days)
- Fugl-Meyer Assessment Scale - Balance (construct: measure of impairment of standing and balance functions)(20 days)
- Box and Block Test(20 days)
- Fugl-Meyer Assessment Scale - Range of Motion of Joints (construct: measure joints' passive range of motion)(20 days)
- Reaching Performance Scale (construct: measure of the ability to reach targets in the frontal space of upper limb affected by paresis)(20 days)
- Modified Ashworth Scale (construct: measure of spasticity at the upper limb)(20 days)
研究者
Andrea Turolla
PT, PhD
IRCCS San Camillo, Venezia, Italy