Comparison of the Effects of Cycling Functional Electrical Stimulation and Conservative Rehabilitation Therapy on the Functional Status and Muscle Characteristics of Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Functional Ambulation Scale
研究概览
简要总结
Comparison of the effects of cycling functional electrical stimulation and conservative rehabilitation therapy on the functional status and muscle characteristics of stroke patients
详细描述
Stroke is the second leading cause of death worldwide and is a major contributor to disability. It is one of the developments related to bleeding as a result of occlusion of blood vessels in the brain with a clot or damage from the vessels.Loss of strength and motor coordination in the lower and upper extremities is the main cause of disability after stroke. Activities such as walking, standing, sitting and daily activities such as dressing, bathing and toilet are frequently affected and sensorimotor disorders are common.
Functional electrical stimulation (FES) is one of the methods used in treatment. FES provides muscle contraction and movement by electrical stimulation of motor neurons. It is applied by a controller through skin electrodes to induce contractions. The FES-evoked bike allows people with or without voluntary leg movement to pedal an exercise bike on a fixed system.
In this study, the investigators aimed to compare the treatment efficacy and changes in muscle characteristics of conservative treatment and cycling FES in stroke patients.
Demographic data of the patients and healthy volunteers will be recorded. Hemiplegic patients will be evaluated in terms of Barthel Index, Modified Ashworth Scale, Berg Balance Scale, Functional Ambulation Scale, Brunnstrom's Hemiplegia Recovery Stage, Fatigue Severity Scale, Fugl-Meyer Assessment, 6-Minute Walking Test, Muscle strength measurement, pennation angle and thickness measurement of the musculus rectus femoris muscle
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
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be between the ages of 21-
- •The time elapsed after stroke must be between 3-60 months.
- •Patients must have had cerebrovascular disease for the first time.
- •Patients' Functional Ambulation Scale grade ≤ 4
- •Patients must be able to sit unsupported for 30 minutes and walk 6 meters with support or device.
- •Patients' mini mental test score ≥ 24
排除标准
- •Patients with peripheral nerve injury in the lower extremity
- •Patients with a pacemaker or a pacemaker.
- •Patients with severe spasticity of the lower extremities
- •Patients with a history of more than one cerebrovascular disease
- •Patients with a history of lower extremity fractures in the last 6 months
- •Patients diagnosed with Parkinson, Multiple Sclerosis
- •Patients with unstable cardiac pathology
- •Patients' mini mental test score ≤ 24
结局指标
主要结局
Functional Ambulation Scale
时间窗: 6 Week After Treatment
Functional Ambulation Scale is a 6-point functional walking test that evaluates ambulation ability and determines the amount of human support required by patients while walking, regardless of whether they use a personal assistive device. A score of 0 indicates that the patient has a dysfunctional ambulation A score of 5 denotes independent ambulation on any surface.
Brunnstrom Stages
时间窗: 6 Week After Treatment
Brunnstrom stages is a scale used to assess motor recovery after a stroke, which is expressed using values between 1 and 6. The higher the value on this scale, the higher would be the recovery.
Berg Balance Scale
时间窗: 6 Week After Treatment
The BBS is used to objectively determine a patient's ability to balance safely during a predetermined set of tasks. The scale comprises 14 items. Each item receives a score ranging from 0 to 4, which is a five-point rank scale with 0 indicating the lowest level of functioning and 4 indicating the highest level of functioning
次要结局
- Modified Ashworth Scale(6 Week After Treatment)
- Barthel Index(6 Week After Treatment)
- 6 min walking test(6 Week After Treatment)
- Rectus Femoris Muscle Thickness(6 Week After Treatment)
- Pennate angle(6 Week After Treatment)
- Fugl-Meyer Assessment for lower extremity(6 Week After Treatment)
- Fatigue Severity Scale(6 Week After Treatment)
- Muscle strength measurement:(6 Week After Treatment)
研究者
Serdar Kilinc
Assistant Professor
Abant Izzet Baysal University