Efficacy and Time Dependent Effects of Transcranial Direct Current Stimulation (tDCS) Combined With Mirror Therapy for Rehabilitation After Subacute and Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 3
- 主要终点
- Change scores of Fugl-Meyer Assessment (FMA)
研究概览
简要总结
This project is designed to investigate the intervention effects and time dependent effects of combining tDCS and MT in patients with subacute and chronic stroke.
详细描述
This project is also designed to investigate the optimal application timing of tDCS in combination with MT in patients with subacute and chronic stroke. Patients with subacute and chronic stroke will be recruited and randomized into one of the 3 groups: sequentially apply tDCS and MT group (SEQ), apply tDCS concurrently with MT group (CON), and MT with sham tDCS group (SHAM). All participants will receive 40 minutes of MT followed by 30 minutes of functional task training. For the participants in the SEQ group, 20 minutes of tDCS will be applied prior to MT, while tDCS will be applied concurrently with MT for the first 20 minutes in the CON group. As for the SHAM group, tDCS electrodes will be placed on the scalp without actual current output. The interventions will be carried out 90 minutes per day, 5 days per week, for 4 weeks. Behavioral outcomes will be assessed by blinded evaluators before, after, and 3 months post intervention. To study the possible interaction of treatment group and time of outcome evaluations, group (SEQ vs. CON vs. SHAM groups) × time (pretest vs. posttest vs. follow-up) repeated measures ANOVA will be performed. Additionally, the partial eta square (η2) will be calculated to determine the effect size of interest.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •experienced a first-ever unilateral stroke with stroke onset ≥ 1 week;
- •UE-FMA score between 18 and 56
- •able to follow instructions to perform the tasks (Mini Mental State Examination ≥ 24)
排除标准
- •Participants are currently involved in other rehabilitation or drug research trial(s);
- •have neurological or psychological disorders other than stroke;
- •have joint contracture or excessive spasticity of the paretic upper limb that prohibits them performing the tasks;
- •received Botulinum toxin injections 3 months prior to enrollment
- •have unstable cardiovascular status such as uncontrolled hypertension or New York Heart Association (NYHA) Class III/IV heart failure;
- •have contradictions to tDCS including a history of epilepsy, migraine headache, uncontrolled medical status, being pregnant, having a pacemaker, or metal implanted in their head or body
- •have a history of drug or alcohol abuse, skin lesions on the electrode sites, brain tumor, brain injury, arteriovenous malformation (AVM), had brain surgery, other brain diseases (such as intracranial hypertension or cerebral edema), or being not suitable for using tDCS by the physician's assessment.
结局指标
主要结局
Change scores of Fugl-Meyer Assessment (FMA)
时间窗: baseline, 1 month, 4 months
The UE-FMA subscale will be used to assess the sensorimotor impairment level of UE in patients after stroke. The UE-FMA contains 33 movements with a score range from 0 to 66. A higher UE-FMA score indicates less impairment of the paretic limb. The validity and reliability of FMA is good to excellent.
次要结局
- Change scores of Adelaide Activities Profile (AAP)(baseline, 1 month)
- Change scores of 10-Meter Walk Test (10MWT)(baseline, 1 month)
- Change scores of Stroop test(baseline, 1 month)
- Change scores of pressure pain threshold(baseline, 1 month)
- Change scores of Dual-Task Block and Box Test(baseline, 1 month, 4 months)
- Change scores of Wolf Motor Function Test (WMFT)(baseline, 1 month)
- Change scores of Motor Activity Log (MAL)(baseline, 1 month, 4 months)
- Change scores of Actigraphy(baseline, 1 month)
- Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)(baseline, 1 month, 4 months)
- Change scores of MyotonPro(baseline, 1 month)
- Change scores of EuroQol (EQ)-5D questionnaire(baseline, 1 month)
- Change scores of Medical Research Council scale (MRC)(baseline, 1 month)
- Change scores of Modified Ashworth Scale (MAS)(baseline, 1 month)
- Change scores of Pinch and grasp dynamometer(baseline, 1 month)
- Change scores of The Facial Pain Scale-Revised (FPS-R )(baseline, 1 month)
- Change scores of Revised Nottingham Sensory Assessment (rNSA)(baseline, 1 month)
- Change scores of ABILHAND Questionnaire(baseline, 1 month, 4 months)
- Change scores of The Chedoke Arm and Hand Activity Inventory (CAHAI)(baseline, 1 month)
- Change scores of Modified Rankin Scale (mRS)(baseline, 1 month)
- Change scores of The short form of the Betts Questionnaire Upon Mental Imagery (Betts QMI)(baseline, 1 month)
- Change scores of The Facial Fatigue Scale-Revised (FFS-R)(baseline, 1 month)
- Change scores of Functional Independence Measure (FIM)(baseline, 1 month)
- Stroke Impact Scale Version 3.0 (SIS 3.0)(baseline, 1 month, 4 months)