Investigating the Feasibility of Combining Virtual Reality and Bilateral Transcranial Direct Stimulation to Improve Upper Limb Recovery in Patients With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Wolf Motor Function Test (WMFT)
研究概览
简要总结
Following a stroke, the function of the distal upper limb, especially hand and finger movements, is often severely compromised, significantly restricting the ability to carry out daily activities. It is estimated that 55-75% of stroke survivors suffer from motor dysfunction, with upper limb impairments affecting up to 85% of them (Tang et al., 2024). Current rehabilitation approaches, while beneficial, often produce limited gains in hand function, particularly in patients with chronic stroke. Virtual reality (VR) training has emerged as a promising tool in neurorehabilitation, providing repetitive, task-specific, and engaging practice environments that can promote motor learning (Cameirão et al., 2012). tDCS has also shown potential to enhance motor recovery when combined with motor practice (Kang et al., 2016). To date, no studies have directly compared the effectiveness of Bi-tDCS with VR for improving upper limb function after 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- Adult participants (over 18 years of age) (Elsner et al., 2020).
- •2- Patients with a unilateral cerebral infarction or haemorrhage who are at least three months post-stroke (Muller et al., 2021).
- •3- Adequate mental status confirmed by an MMSE (Arabic version) should be ≥24 (Kim, 2021). ensuring the ability to comprehend and follow instructions.
- •4- Modified Ashworth scale score < 3 (Ögün et al., 2019). 5- Fugl-Meyer assessment (FMA) scores between 29 and 58, indicating moderate impairments (Woytowicz et al., 2017).
排除标准
- •Visual impairment and severe hemisensory neglect or inattention (Stahl et al., 2019; Fluet1 et al., 2015).
- •2- Individuals who have aphasia find it difficult to follow instructions (Fluet et al., 2015).
- •3- Presence of any medical condition that contraindicates the use of non-invasive brain stimulation (Stahl et al., 2019; Learmonth et al., 2021).
- •4- History of neurological disorders unrelated to stroke or participation in another study.
结局指标
主要结局
Wolf Motor Function Test (WMFT)
时间窗: at baseline and after intervention (4 weeks).
The WMFT is a standardized assessment used to measure upper extremity motor ability through the performance of 17 tasks that include both functional and strength components. Rated using the 6-point scale ranging from 0 (no attempt) to 5 (normal movement). The total performance time and quality of movement are recorded, with lower scores indicating lower levels of functioning.
Fugl-Meyer Assessment Scale Upper Extremity (FMA-UE):
时间窗: at baseline and after intervention (4 weeks).
The FMA-UE is a comprehensive quantitative measure designed to evaluate motor function, coordination, and reflex activity of the affected upper limb following stroke. It uses a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), with a maximum score of 66 points for the upper extremity. It is considered the gold standard for assessment of upper limb motor recovery.
Box and Block Test (BBT):
时间窗: at baseline and after intervention (4 weeks).
The BBT is a validated measure of gross manual dexterity that evaluates how many 1-inch wooden blocks a participant can transfer from one compartment to another within 60 seconds using one hand. The apparatus consists of a wooden box divided into two equal sections containing 150 small cubes. The test begins with the unaffected upper limb to allow practice and establish a baseline performance. Participants are then instructed to move as many blocks as possible, one at a time, over the partition within the time limit. The score is defined as the total number of blocks successfully transferred within 60 seconds.
Cortical Excitability Assessment:
时间窗: at baseline and after intervention (4 weeks).
Corticospinal excitability will be evaluated using transcranial magnetic stimulation (TMS) to measure motor evoked potentials (MEPs) elicited by TMS in both the affected and unaffected motor cortices (Wassermann et al., 2008). Electromyographic (EMG) activity will be monitored in real-time during TMS application, with MEPs recorded bilaterally from the first dorsal interosseous (FDI)
Functional magnetic resonance imaging (fMRI):
时间窗: at baseline and after intervention (4 weeks).
Functional magnetic resonance imaging (fMRI), a specialized form of MRI, will be utilized to assess brain activity and neural connectivity. The fMRI protocol will employ a block design paradigm, with each scanning session lasting 6 minutes and divided into six blocks. Each block will consist of 15 repetitions of 2-second contractions, separated by 30-second rest intervals (Wen et al., 2014). During the task, participants will be instructed to squeeze a rubber ball with their affected hand at an intensity corresponding to 30% of their maximum voluntary contraction force (Cheng et al., 2021; Ismail et al., 2014). Visual cues will be displayed to assist participants in achieving the target force level (Könönen et al., 2012).
次要结局
- The Arabic version of the Stroke Specific Quality of Life Scale (SS-QOL):(at baseline and after intervention (4 weeks).)
- Arabic Version of Stroke Impact Scale (SIS-16):(at baseline and after intervention (4 weeks).)