The Effects of Transcranial Direct Current Stimulation on Improving Impairment and Functional Activity in Individuals With Stroke: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Change in Functional Mobility (TUG)
研究概览
简要总结
Stroke patients often experience impaired balance and weight-bearing due to muscle weakness and neurological deficits. Motor rehabilitation is a crucial goal in their recovery, and transcranial direct current stimulation (tDCS) has emerged as a promising therapeutic approach. When combined with motor training, tDCS can enhance walking and balance abilities. However, there is a lack of research exploring the combination of unstable surfaces training, cognitive function, and tDCS for stroke rehabilitation
详细描述
Stroke is a leading cause of long-term disability worldwide, often resulting in impaired motor function, reduced walking ability, decreased muscle strength, and cognitive deficits. These limitations contribute to difficulties in activities of daily living, impaired balance, and reduced quality of life. Effective rehabilitation strategies are essential to promote functional recovery and reduce the risk of long-term dependence.
Transcranial direct current stimulation (tDCS) has emerged as a promising non-invasive neuromodulation technique to facilitate cortical excitability and enhance neuroplasticity in individuals with stroke. Anodal stimulation over the lesioned hemisphere has been shown to improve motor performance and cognitive processing, while sham stimulation does not induce comparable effects. Recent studies suggest that combining tDCS with task-specific rehabilitation programs may provide synergistic benefits by simultaneously enhancing neural activation and functional task performance.
Dual-task training, particularly stepping exercises performed on unstable surfaces, has been demonstrated to challenge both motor and cognitive systems simultaneously. This approach targets balance, gait adaptation, and executive function by requiring patients to divide attention between locomotion and cognitive demands. When applied in combination with tDCS, dual-task training may enhance neuroplasticity and strengthen functional outcomes beyond those achieved by conventional training alone.
The present randomized controlled trial is designed to investigate the combined effects of anodal tDCS and dual-task stepping exercise on unstable surfaces in stroke survivors. Participants will be randomized into three groups: (1) active tDCS combined with dual-task stepping, (2) dual-task stepping with sham tDCS, and (3) active tDCS alone. Interventions will be delivered three times per week for four weeks.
Primary outcomes will include measures of functional ability, walking speed, walking endurance, lower limb muscle strength, and cognitive ability. Secondary outcomes will explore the effects of combined stimulation on balance and overall motor recovery. It is hypothesized that participants receiving combined anodal tDCS and dual-task training will demonstrate greater improvements in both motor and cognitive outcomes compared with either intervention alone.
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 (Participant)
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers were diagnosed with cerebrovascular disease, aged 18 years and above, both male and female.
- •Body mass index between 18.5-29.9 kg/m2 1.1.
- •No history of falls in the 6 months prior to the study. 1.1.
- •Able to follow instructions and consent to participate in the study. 1.1.
- •Able to communicate with the researcher and provide information by themselves.
- •Able to walk continuously for at least 10 meters safely.
排除标准
- •1.2.1 Having undergone surgery to insert metal implants in the body, such as pacemakers, deep brain electrodes.
- •1.2.2 High blood pressure, uncontrolled heart disease, or having underlying diseases, such as osteoarthritis, arthritis, such as gout, rheumatoid arthritis, severe and affecting treatment.
- •1.2.3 Having a wound on the skull and abnormal sensation. 1.2.4 Having a history of injury or pain in the extremities. At a pain score of more than 5 out of a full score of 10, assessed by (Visual Analog Scale) 1.2.5 There is a condition of the inner ear that is disturbed, affecting balance, such as tinnitus.
- •There are unresolved vision and hearing problems. 1.3 Criteria for withdrawing volunteers from the research 1.3.1 If a volunteer experiences pain or discomfort during the test, the test will be stopped and the volunteer will be removed from the research immediately.
- •1.3.2 The volunteer requests to withdraw or is unwilling to continue the research.
结局指标
主要结局
Change in Functional Mobility (TUG)
时间窗: 4 week
Balance control was measured using the Timed up and go test (TUGT). The tester measured the time it took the volunteers to stand up from a chair, walk straight ahead for 3 meters, turn around a cone, and walk back to sit in the chair at maximum speed and safety for 3 times. The average time taken by the volunteers in seconds was then calculated.
Change in Functional Mobility (10MWT)
时间窗: 4 week
Walking speed: The time taken to walk a distance of 10 meters (10-meter walk test: 10MWT) at normal and maximum speeds was measured. The tester measured the time taken for the 4 meters in the middle of the entire walkway. The test was repeated 3 times/speed and the average of each speed was calculated in meters/second. The movement was analyzed using a 2D (high-speed) motion analysis program.
Change in Functional Mobility ( 6MWT)
时间窗: 4 week
Functional endurance was measured using a 6-minute walk test (6MinWT) in which subjects walked as far as possible around a rectangular walkway. During the test, subjects were allowed to stand and rest without interrupting the test time. At the end of the test, the tester measured the distance covered by the subjects.
Change in Functional Mobility (FTSST)
时间窗: 4 week
Functional muscle strength test of the leg muscles using the Five times sit-to-stand test (FTSST) as quickly and safely as possible without using hands. The test was repeated 3 times and the average was calculated.
Change in Functional Mobility (BBS)
时间窗: 4 week
Berg Balance Scale (BBS), a healthcare provider gives a person 14 tasks, such as sitting to standing, standing unsupported, and reaching for objects, scoring their performance from 0 (unable to complete) to 4 (normal). The total score out of 56 indicates functional balance, with higher scores showing better balance and lower scores suggesting a greater risk of falling. The assessment takes about 15-20 minutes and requires simple equipment like a chair, stopwatch, and step stool
Change in Functional Mobility (Fugl-Meyer Assessment (FMA))
时间窗: 4 week
The Fugl-Meyer Assessment (FMA) assesses motor function, sensation, balance, joint range of motion, and joint pain, typically in stroke patients, using a standardized 3-point scale (0=cannot perform, 1=performs partially, 2=performs fully) for each item. An examiner observes the patient's ability to complete tasks and assigns scores for the upper extremity motor (66 points), lower extremity motor (34 points), sensation (24 points), balance (14 points), and joint pain and range of motion (44 points each). The final score, a number out of a possible 226, indicates the level of recovery, with higher scores signifying better functional ability
Change in Functional Mobility (TUG)
时间窗: 4 week
Balance control was measured using the Timed up and go test (TUGT). The tester measured the time it took the volunteers to stand up from a chair, walk straight ahead for 3 meters, turn around a cone, and walk back to sit in the chair at maximum speed and safety for 3 times. The average time taken by the volunteers in seconds was then calculated.
Change in Functional Mobility (10MWT)
时间窗: 4 week
Walking speed: The time taken to walk a distance of 10 meters (10-meter walk test: 10MWT) at normal and maximum speeds was measured. The tester measured the time taken for the 4 meters in the middle of the entire walkway. The test was repeated 3 times/speed and the average of each speed was calculated in meters/second. The movement was analyzed using a 2D (high-speed) motion analysis program.
Change in Functional Mobility ( 6MWT)
时间窗: 4 week
Functional endurance was measured using a 6-minute walk test (6MinWT) in which subjects walked as far as possible around a rectangular walkway. During the test, subjects were allowed to stand and rest without interrupting the test time. At the end of the test, the tester measured the distance covered by the subjects.
Change in Functional Mobility (FTSST)
时间窗: 4 week
Functional muscle strength test of the leg muscles using the Five times sit-to-stand test (FTSST) as quickly and safely as possible without using hands. The test was repeated 3 times and the average was calculated.
Change in Functional Mobility (BBS)
时间窗: 4 week
Berg Balance Scale (BBS), a healthcare provider gives a person 14 tasks, such as sitting to standing, standing unsupported, and reaching for objects, scoring their performance from 0 (unable to complete) to 4 (normal). The total score out of 56 indicates functional balance, with higher scores showing better balance and lower scores suggesting a greater risk of falling. The assessment takes about 15-20 minutes and requires simple equipment like a chair, stopwatch, and step stool
Change in Functional Mobility (Fugl-Meyer Assessment (FMA))
时间窗: 4 week
The Fugl-Meyer Assessment (FMA) assesses motor function, sensation, balance, joint range of motion, and joint pain, typically in stroke patients, using a standardized 3-point scale (0=cannot perform, 1=performs partially, 2=performs fully) for each item. An examiner observes the patient's ability to complete tasks and assigns scores for the upper extremity motor (66 points), lower extremity motor (34 points), sensation (24 points), balance (14 points), and joint pain and range of motion (44 points each). The final score, a number out of a possible 226, indicates the level of recovery, with higher scores signifying better functional ability
次要结局
- Change in Cognitive Function (Montreal Cognitive Assessment (MoCA))(4 week)
- Change in Cognitive Function (Stroop test)(4 week)
- Change in Cognitive Function (Digit Span)(4 week)
- Change in Cognitive Function (Montreal Cognitive Assessment (MoCA))(4 week)
- Change in Cognitive Function (Stroop test)(4 week)
- Change in Cognitive Function (Digit Span)(4 week)
研究者
Chonticha Kaewjoho
Lecturer, Department of Physical Therapy
University of Phayao