Use of Electromyographic Biofeedback in Upper Limb Rehabilitation After Stroke
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Ashworth
研究概览
简要总结
Studies show that the use of electromyographic biofeedback combined with other therapies contributes to the reduction of upper limb spasticity after stroke. However, there is a lack of literature regarding the best protocols to use in clinical practice, as well as functional outcomes after this therapy. The objective of this research project will be to investigate the effect of electromyographic biofeedback on spasticity in individuals post-stroke in the sub-acute phase, and its outcomes regarding upper limb function and participation in activities of daily living. The study will be a randomized, triple-blind clinical trial in which the 45 participants will be divided into two groups: the experimental group will receive electromyographic biofeedback combined with functional training, and the control group will receive functional training with placebo biofeedback alone. The study hypothesis is that the use of electromyographic biofeedback contributes to improved functional outcomes and participation in activities of daily living in patients with upper limb spasticity resulting from 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
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical diagnosis of stroke (imaging tests and a medical report)
- •Spasticity with an Ashworth score equal to or less than 3 in the upper limb
- •20-60 years old
排除标准
- •Other neurological impairments or trauma-orthopedic deformities in the upper limbs
- •botulinum toxin/phenol injections within the previous 5 months
- •medications that reduce muscle tone
- •aphasia that prevents basic communication
- •low vision or low visual acuity that prevents them from viewing the screen.
结局指标
主要结局
Ashworth
时间窗: Ashworth will be applied at pre (baseline), through study completion, an average of 1 month.
The Ashworth scale will be used to measure the degree of spasticity of the upper limb muscles. The test will be performed manually and the score ranges from zero to four points. The higher the score, the greater the spasticity of the muscle tested.
次要结局
- Upper limb function and participation - Motor Activity Log (MAL)(The tests will be applied at pre (baseline), through study completion, an average of 1 month.)
- Upper limb function and participation - Fugl-Meyer Assessment Scale(The tests will be applied at pre (baseline), through study completion, an average of 1 month.)
- Upper limb function and participation - The Functional Independence Measure (FIM)(The tests will be applied at pre (baseline), through study completion, an average of 1 month.)
- Upper limb function and participation - Modified Ashworth scale(The tests will be applied at pre (baseline), through study completion, an average of 1 month.)
- Upper limb function and participation - Box and Block Test (BBT)(The tests will be applied at pre (baseline), through study completion, an average of 1 month.)
- Upper limb function and participation - Jebsen Manual Function Test (JTT)(The tests will be applied at pre (baseline), through study completion, an average of 1 month.)
研究者
Henrique Cunha Carvalho
PhD.
Universidade Federal do Paraná