Effect of Combining Transcutaneous Vagus Nerve Stimulation With Peripheral Nerve Stimulation on Upper Limb Motor Function in People With Stroke: A Single- Blinded Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Fugl-Meyer assessment of upper extremity (FMA-UE)
研究概览
简要总结
the current study is a Blinded Randomised Controlled Trial investing the effectiveness of Combining Transcutaneous Vagus Nerve Stimulation with Peripheral Nerve Stimulation on Upper Limb Motor Function in People with 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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 55 - 75 years old;
- •diagnosed with stroke confirmed by magnetic resonance imaging or computed tomography for more than 6 months;
- •had volitional control of the non-paretic arm and at least minimal antigravity movement in the paretic shoulder;
- •had at least 5 degrees of wrist extension in the antigravity position;
- •be able to communicate
排除标准
- •had neurological disease other than stroke, e.g., Parkinson's disease or dementia;
- •ongoing healthy condition, e.g., angina pectoris, pain, or arthritis;
- •had any contraindications of taVNS (metal implants in the brain, history of seizure)
研究组 & 干预措施
taVNS + TENS
participate will received taVNS cominged with TENS
干预措施: transcutaneous auricular vagus nerve stimulation (Device)
taVNS + TENS
participate will received taVNS cominged with TENS
干预措施: transcutaneous electrical nerve stimulation (Device)
taVNS + TENS
participate will received taVNS cominged with TENS
干预措施: task-oriented training (Other)
sham-taVNS + TENS
participate will received sham-taVNS cominged with TENS
干预措施: sham transcutaneous auricular vagus nerve stimulation (Device)
sham-taVNS + TENS
participate will received sham-taVNS cominged with TENS
干预措施: transcutaneous electrical nerve stimulation (Device)
sham-taVNS + TENS
participate will received sham-taVNS cominged with TENS
干预措施: task-oriented training (Other)
taVNS + sham-TENS
participate will received taVNS cominged with sham-TENS
干预措施: transcutaneous auricular vagus nerve stimulation (Device)
taVNS + sham-TENS
participate will received taVNS cominged with sham-TENS
干预措施: sham transcutaneous electrical nerve stimulation (Device)
taVNS + sham-TENS
participate will received taVNS cominged with sham-TENS
干预措施: task-oriented training (Other)
control training group
participate will receive exercise training only
干预措施: task-oriented training (Other)
结局指标
主要结局
Fugl-Meyer assessment of upper extremity (FMA-UE)
时间窗: Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).
The FMA-UE was used to assess motor impairment. It includes 33 items assessing movement, coordination, and reflex actions of the shoulder, elbow, forearm, wrist, and hand joints of the paretic arm. Each item consists of a 3-point scale (0, 1, and 2), with a total maximum score of 66.
Chinese version of brief memory and executive test (BMET)
时间窗: Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).
The Chinese version of BMET will be used to assess cognitive function. It incorporates tests divided into two main categories: i) executive functioning and processing speed; and ii) orientation and memory. The initial performance of each item is converted to item score (0-2) and the total score (0-16) was used for statistical analysis, where a higher score indicates better general cognitive function.
次要结局
- Jacket test(Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).)
- Motor Activity Log (MAL)(Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).)
- Capabilities of upper extremity test (CUE-T)(Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).)
- Hand grip strength(Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).)
- Pinch grip strength(Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).)
- Capabilities of upper extremity-questionnaire (CUE-Q)(Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).)
- Stroke impact scale (SIS)(Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).)
- Community integration measure(CIM)(Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).)