Effects of Neuromuscular Electrical Stimulation in Muscle Architecture and Functionality of Patients After Acute Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Quadriceps muscle thickness
研究概览
简要总结
Introduction: Stroke is a sudden illness, responsible for important neurological and cognitive sequelae that can result in functional limitations and dependence. It is the leading cause of neurological impairment in young adults and resting-related muscle loss is one of the major factors involved. Early rehabilitation is essential for these patients and neuromuscular electrical stimulation (NMES) has been identified as an intervention alternative due to its known effects on the prevention of muscle loss in patients with various pathologies. Objective: To evaluate the effects of NMES associated with conventional physiotherapy compared to conventional physiotherapy on muscle thickness and functionality of patients with acute stroke. Methodology: This is a randomized clinical trial, which will be performed at the Emergency and Unit Unit of the Stroke of the Hospital de Clínicas of Porto Alegre (HCPA). Patients with acute stroke, with up to 72 hours of hospital admission, who present with lower limb force deficit due to the current stroke will be included. Patients will be randomized into two groups: intervention group, who will receive the application of NMES associated with conventional physiotherapy and control group, who will receive the conventional physiotherapy of the HCPA. NMES training will be applied once a day (30 minutes of application per session with an increase of five minutes each week and gradual reduction in OFF time), five days a week until hospital discharge or up to a maximum of three weeks. The following outcomes will be assessed before and after the intervention: quadriceps and tibial thickness and quality of the quadriceps and tibialis anterior, muscle strength, stroke severity, gait, functionality and disability.
详细描述
Stroke is the leading cause of neurological impairment in young adults, and early rehabilitation is essential for the recovery of these patients.
It is already known that muscle loss is one of the main factors responsible for functional disability and dependence in stroke survivors, being observed already in the acute phase and mainly in the lower limbs. The physiological mechanisms involved in stroke-related muscle loss, such as muscle inactivity, denervation, malnutrition, inflammation and metabolic disorders, among others have been reported in studies, but there is no consistent evidence regarding effective therapies to avoid muscle loss.
The NMES is already widely used for the prevention of muscular loss in patients with various pathologies. Studies have also reported the efficacy of NMES in patients with subacute or chronic stroke. In patients with acute stroke, the literature is rather scarce. The investigators are aware of only one study that evaluated the effects of NMES on muscle mass loss, but the authors did not evaluate the effects of this intervention on the physical performance or functionality of the patients. Thus, the investigators consider the importance of further studies to know the effects of NMES on muscle loss in patients with acute stroke and the need to evaluate the effects of NMES on the physical performance functionality of these patients aiming at the possibility of offering an intervention option precocious and effective for this population.
The objective of this study is to evaluate the effects of NMES associated with conventional physiotherapy compared to conventional physiotherapy in the muscular architecture and functionality of patients with acute stroke.
This is a randomized clinical trial in which the participants will be randomly divided into experimental group (EG) and control group (CG), being evaluated before and after the intervention.
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)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of ischemic or hemorrhagic stroke performed by a neurologist based on clinical and neuroimaging characteristics;
- •To present motor sequelae in the lower limb due to stroke.
排除标准
- •Previous motor deficits
- •Complete recovery of motor deficits before the initial evaluation;
- •Conditions that prevent neuromuscular electrical stimulation such as skin lesions at the site of electrode placement, pacemaker and therapy intolerance.
- •Time greater than 72 hours since hospitalization.
研究组 & 干预措施
Neuromuscular Electrical Stimulation
The experimental group will receive the application of NMES associated with conventional physiotherapy. After the NMES application, conventional physiotherapy will be performed. The exercises performed will be according to the patient's physical condition, and the conducts will always be performed seeking the maximum possible functional performance for the patient. The conducts adopted according to the standard routine of the HCPA stroke unit are: passive, active, assisted and / or active exercises; muscle stretching; selective hip extension; trunk stabilization training in sedestation; orthostasis training and walking training.
干预措施: Neuromuscular Electrical Stimulation (Other)
Group Control
The control group will only receive conventional physiotherapy, composed of the same exercises performed in the experimental group.
结局指标
主要结局
Quadriceps muscle thickness
时间窗: three weeks
Evaluated by muscular echography (cm)
Thickness of the anterior tibial muscle
时间窗: three weeks
Evaluated by muscular echography (cm)
次要结局
- 10-meter walking test(three weeks)
- Functional walking - Functional Ambulation Categories(three weeks)
- Dynamometry - ankle dorsiflexion(three weeks)
- Muscle strength - Medical Research Council (MRC) Scale(three weeks)
- Sit and stand up to 30 seconds(three weeks)
- Functionality - Barthel Index for Activities of Daily Living(three weeks)
- Dynamometry - Knee extension(three weeks)
- Modified Rankin Scale(three weeks)