Hand Rehabilitation With Music Therapy Technique (Sonification) and Leap Motion Controller in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 5
- 主要终点
- Fugl-Meyer Motor Assessment Scale
研究概览
简要总结
The study uses a specific hand tracking sensor (Leap Motion Controller) to catch the movements of the arm combined with proper pre-defined musical patterns (sonification) in a neurologic music therapy perspective. The aim of the experiment is to verify the efficacy of sonification technique (compared to usual care) in the hand rehabilitation of patients with stroke.
详细描述
Introduction:
Every year in Italy occur over than 200.000 new stroke cases. The virtual and augmented reality offers a valid support to the rehabilitation program by providing objectives parameters for the patient evaluation, accelerating the motor recovery process and enhancing the motor performance after the discharge. This study uses a specific hand tracking sensor (Leap Motion Controller) to catch the movements of the arm combined with proper pre-defined musical patterns (sonification) in a neurologic music therapy perspective.
In addition to its use in relational contexts, in fact, music therapy is widely used in the field of rehabilitation, and in particular in the neuromotor rehabilitation, due to the impact of the sound, as well as on paralimbic and limbic areas, the areas of the brain involved in the movements (motor cortex, supplementary motor area, cerebellum, basal ganglia, etc.).
Recent studies uses sonification for the rehabilitation of the upper limbs assuming a replacement of the proprioceptive aspects damaged by the disease thanks to the audio-motor feedback. This study, furthermore, exploits the specificities of the Leap Motion Controller and the peculiarities of the sound stimuli that accompany the arm movement without requiring cognitive tasks.
Objectives:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-85 years old
- •ischemic lesion in one hemisphere (hemiplegia / hemiparesis right or left)
- •Mini Mental State Examination > 24 onset acute event not later than 180 days prior to study entry
排除标准
- •Dated lesions beyond 6 months from onset
- •Multiple or bilateral lesions
- •Mini Mental State Examination <24
- •Presence of neglect
- •Previous or concomitant disabling diseases for upper limb function (Eg: Parkinson's disease, multiple sclerosis, shoulder's periarthritis, Dupuytren's disease, etc.)
- •Previous rehabilitative treatments with music
结局指标
主要结局
Fugl-Meyer Motor Assessment Scale
时间窗: 4 weeks
Primary endpoint of the study is given by the measurement of proximal and distal upper limb motor skills assessed by the Fugl-Meyer Motor Assessment Scale. The primary endpoint will be assessed by comparing the variation between T0 and T2 of the scale scores above mentioned in the experimental and control groups.
次要结局
- McGill Quality of Life(up to 8 weeks)
- Numerical Pain Rating Scale (NPRS)(up to 8 weeks)
- Box and Block Test (BBT)(up to 8 weeks)
- Visual Analogue Scale (VAS)(up to 8 weeks)
- Modified Ashworth Scale(up to 8 weeks)