The Effects of Anodal and Cathodal Transcranial Direct Current Stimulation Combined With Conventional Physical Therapy in Patients With Acute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Wolf Motor Function Test
研究概览
简要总结
The objective of the study is thus to compare the effects 5 consecutive sessions of anodal and cathodal tDCS combined with conventional physical therapy on upper and lower limb motor performance in acute stroke at immediate, and 1-month followup.
详细描述
Stroke is a major cause of long-term disability in stroke survivors that related with motor impairment. After stroke, the cortical excitability of ipsilesional hemisphere is decreased; in contrast, the cortical excitability of contralesional hemisphere is increased. Conventional physical therapy is beneficial to motor recovery, but early rehabilitation was not always help the patients get full recovery. tDCS is an adjuvant tools which deliver weak direct current through scalp to promote motor recovery in stroke rehabilitation. The anodal-tDCS increases cortical excitability, while the cathodal-tDCS decreases cortical excitability. Previous studies demonstrated that both monocephalic techniques of tDCS can improve motor function in chronic, subacute, and acute phase, but it is still inconclusive that which monocephalic montages had better effect, especially in acute phase. There are several studies supported the benefits of monocephalic tDCS combined with rehabilitation programs on upper and lower limbs motor function in acute stroke. However, there is no evidence that directly compared the effect of monocephalic tDCS in acute stroke patients. The objective of the study is to compare the effects of anodal and cathodal tDCS combined with conventional physical therapy for 5 sessions on motor performance in acute stroke at immediate, and 1-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke patients who have aged between 18 and 75 years
- •Having a first ever-ischemic stroke that are confirmed by MRI/CT scan
- •Post stroke onset 2-10 days
- •Be able to follow command
- •Be able to walk with or without assistive device (Modified Ranking Scale ≤ 4)
- •Free of any neurological antecedent or unstable condition (such as epilepsy) or cancer.
- •Be able to initiate the upper limb movement
排除标准
- •Recurrent stroke
- •National Institute of Health Stroke Scale ≥ 20 points
- •Presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker
- •Having excessive pain in any joint of the lower limb (numerical pain rating score > 4/10)
- •Having an open wound or wound infraction on scalp
- •Having neglect or psychological diseases (such as schizophrenia, major depression)
结局指标
主要结局
Wolf Motor Function Test
时间窗: 5 minutes
The participants will be asked to perform 2 items that consist of reaching a can and reaching a pen because two tasks is the most common reaching task of hand functions in daily living activities.
Five Times Sit to Stand Test
时间窗: 5 minutes
Subjects will sits on the chair and place their back against the chair. Timing will begin at "GO", the subjects will be asked to walk 3m, turn, walk back, and sit down. The stopwatch stops when the patient's buttocks touch the seat.
Muscle strength
时间窗: 10 minutes
The strength of UE (shoulder flexor, shoulder extensor, elbow extensor, wrist extensor) and LE (hip extensor, hip flexor, knee extensor and ankle dorsiflexor) will be assessed by hand-held dynamometer
Fugl-Meyer Assessment
时间窗: 20 minutes
gold standard and widely used tool to assess sensorimotor in stroke. The item from upper limb and lower limb section will be used. The items are rated on a 3-point ordinal scale as follows: 0 = unable to perform; 1 = partial ability to perform; and 2 = near normal ability to perform.
Time-up and go test
时间窗: 5 minutes
The TUG test is a commonly used screening tool to measure basic mobility correlating to dynamic balance. Start from sitting, stand up, walk 3 meters, turn around, walk back 3 meters and sit down. Timed to complete the task represent the body transfer and gait performance
次要结局
- Hemodynamic response (VMR%)(15 minutes)