A Randomized Controlled Clinical Trial of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment of the Upper Extremity
研究概览
简要总结
Upper limb impairment is present in more than 85% of people with stroke, which greatly affect the quality of life, social participation, and performance of daily activities of people with stroke. Previous study also revealed that 53.4% of people after stroke experienced cognitive impairment. Different cognitive domains might be affected following stroke, such as attention, memory, language, and orientation, and the problems with memory are often prominent. Yet, there is no effective treatment for the post-stroke cognitive impairment.
Transcutaneous spinal cord stimulation (tSCS) and transcutaneous vagus nerve stimulation (tVNS) are simple and non-invasive treatment to improve upper limb motor function and cognitive function. However, no existing studies have explored on the effects of tSCS and tVNS on cognitive function in people with stroke. Therefore, the purpose of this study is to evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) on improving upper limb function and cognitive function in people with chronic stroke.
详细描述
This study aims to investigate the effects of three intervention protocols in people with stroke. The participants in Group A will receive tSCS on C6 and T5 level of the spine with upper limb exercises. The participants in Group B will receive tVNS on the cymba conchae of left outer ear with upper limb exercises. The participants in Group C will receive placebo stimulation with upper limb exercises.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 50 and 80;
- •have suffered from a single stroke at least 6 months;
- •had volitional control of the non-paretic arm and at least minimal antigravity movement in the paretic shoulder;
排除标准
- •have cardiac pacemaker or cochlear implant;
- •have other neurological diseases;
- •are taking medication that may affect measured outcomes;
- •have skin lesions, infection, or inflammation near selected position;
- •are participating in other drug/treatment programs.
研究组 & 干预措施
tSCS
The participants will be received eighteen 45-minute sessions of intervention, 3 sessions per week for 6 weeks.
干预措施: tSCS (Device)
tVNS
The participants will be received eighteen 45-minute sessions of intervention, 3 sessions per week for 6 weeks.
干预措施: tVNS (Device)
Control
The participants will be received eighteen 45-minute sessions of intervention, 3 sessions per week for 6 weeks.
干预措施: Control (Device)
结局指标
主要结局
Fugl-Meyer Assessment of the Upper Extremity
时间窗: 1-month follow-up (10 week)
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) assesses the motor control, which included the reflex, synergistic and isolated movements and coordination of the upper extremity. It is a 3-point ordinal scale with 33 items and the total score ranges from 0 to 66. In this scale, "0" represents "cannot perform", "1" represents "performs partially" and "2" represents "performs fully". The higher score indicates better motor control of the upper extremity. The FMA-UE has an excellent inter-rater reliability (ICC = 0.98) in people with stroke.
Montreal Cognitive Assessment
时间窗: 1-month follow-up (10 week)
The Montreal Cognitive Assessment (MoCA) is a screening tool to detect cognitive impairment of an individual with a total score of 30. The MoCA assesses different cognitive domains, including executive functioning, immediate and delayed memory, visuospatial abilities, attention, working memory, language, and orientation to time and place. It can identify dementia from controls with a sensitivity of 92.3% and specificity of 91.8% with a cut-off score of 22.
Fugl-Meyer Assessment of the Upper Extremity
时间窗: 1-month follow-up (10 week)
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) assesses the motor control, which included the reflex, synergistic and isolated movements and coordination of the upper extremity. It is a 3-point ordinal scale with 33 items and the total score ranges from 0 to 66. In this scale, "0" represents "cannot perform", "1" represents "performs partially" and "2" represents "performs fully". The higher score indicates better motor control of the upper extremity. The FMA-UE has an excellent inter-rater reliability (ICC = 0.98) in people with stroke.
Montreal Cognitive Assessment
时间窗: 1-month follow-up (10 week)
The Montreal Cognitive Assessment (MoCA) is a screening tool to detect cognitive impairment of an individual with a total score of 30. The MoCA assesses different cognitive domains, including executive functioning, immediate and delayed memory, visuospatial abilities, attention, working memory, language, and orientation to time and place. It can identify dementia from controls with a sensitivity of 92.3% and specificity of 91.8% with a cut-off score of 22.
次要结局
- Wolf Motor Function Test(1-month follow-up (10 week))
- Digit Span Test(Baseline (0 week))
- Arm Activity Measure(Baseline (0 week))
- 12-item Short-Form Survey (second version)(Baseline (0 week))
- Oxford Participation and Activities Questionnaire(Baseline (0 week))
- Trail Making Test(Baseline (0 week))
- Rivermead Behavioural Memory Test - Third edition(1-month follow-up (10 week))
- Muscle stiffness(Baseline (0 week))
- Wolf Motor Function Test(1-month follow-up (10 week))
- Muscle strength(Mid-intervention (3 week))
- Digit Span Test(Baseline (0 week))
- Arm Activity Measure(Baseline (0 week))
- 12-item Short-Form Survey (second version)(Baseline (0 week))
- Rivermead Behavioural Memory Test - Third edition(1-month follow-up (10 week))
- Oxford Participation and Activities Questionnaire(Baseline (0 week))
- Trail Making Test(Baseline (0 week))
- Muscle stiffness(Baseline (0 week))