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临床试验/NCT05497791
NCT05497791已完成不适用

Stroke, Measurement and Rehabilitation With Transcranial Laser Stimulation Plus Neuromuscular Electrical Stimulation

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Inertial Sensor

研究概览

简要总结

The main aim of the study was to investigate the effects of transcranial laser stimulation together with neuromuscular electrical stimulation (NMES) in post-stroke patients.

详细描述

Post-stroke sequelae includes loss functions, such as cognitive and sensory-motor which lead to emotional and social problems, reducing quality of life and well-being. The main aim of the study was to investigate the effects of transcranial laser stimulation together with neuromuscular electrical stimulation (NMES) in post-stroke patients. The clinical trial showed improvement of cognitive function, pain relief, greater manual dexterity, enhancement of physical and social-emotional health which lead to better quality of life and well-being. There was also increased temperature in the treated regions with laser and NMES. Therefore, transcranial laser stimulation associated with NMES can be an important therapeutic resource for rehabilitation after stroke.

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 (Investigator)

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Female and male aged between 35 and 75 years with hemiplegia after stroke (more than 12 months from onset) as well as those who experienced only one episode of stroke.

排除标准

  • Bedridden stroke patients, who had great difficulty standing and walking, psychiatric illnesses, endocrinopathies, heart diseases, severe osteoporosis, cancer, musculoskeletal injuries or disorders in the last six months as well as practitioners of regular physical activity, physical therapy or occupational therapy.

结局指标

主要结局

Inertial Sensor

时间窗: 3 months

Angular measurement of the upper and lower limbs using an inertial sensor.

Cognitive status

时间窗: 3 months

Mini-Mental State Examination: It comprises 11-question to evaluated 5 areas of cognitive function: orientation, registration, attention and calculation, memory, and language. MMSE scores range between 0 and 30, with higher scores reflecting better performance

Subjective pain scale

时间窗: 3 months

Visual Analogue Scales (VAS) of pain intensity: A continuous scale comprised of a horizontal line with 10 cm in length without numeric value was used. The patients were instructed to make a mark with a pen at any point on the line between 2 verbal descriptors, one for each symptom extreme \["No pain" (0) and "as bad as it could be" or "worst imaginable pain\]. A ruler was used to measure distance to determine a score.

次要结局

  • Grip strength(3 months)
  • Quality of Life status(3 months)
  • Well-Being status(3 months)
  • Functional status(3 months)
  • Gross manual dexterity(3 months)
  • Dynamic balance(3 months)
  • Spasticity(3 months)
  • Thermography(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernanda Rossi Paolillo

PhD

University of Sao Paulo

研究点 (2)

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