Using fMRI and sEMG to Evaluate the Effects and Mechanism on Abdominal Acupuncture Combined With Upper Limb Rehabilitation Training on Brain Plasticity of Hemiplegic Patients With Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Motor function of muscles
研究概览
简要总结
Using random number method to categorize the selected first onset patients with stroke who meet the inclusion criteria into 3 groups.The patients were randomly divided into treatment group A(abdominal acupuncture+upper limb rehabilitation training, 22 cases), treatment group B(Sham abdominal acupuncture+upper limb rehabilitation training, 22 cases),and control group(upper limb rehabilitation training, 22 cases). SEMG and fMRI examination and related stroke rehabilitation assessment scales were evaluated before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First onset stroke, Left hemiplegia, Right-handed，and diagnosed by brain CT or MRI;
- •Age 35 to 75 years old;
- •Course of disease 0.5 to 3 months with stable vital signs;
- •No cognitive impairment. Can understand and execute commands. MMSE score more than 7 points. ;
- •Can control the sitting balance. Brunnstrom stage of hemiplegic upper limb and hand is Ⅳ or V ，Fugl-Meyer Motor Assessment score of upper limb 20-50 point;
- •Agree to sign the informed consent;
- •Unilateral neglect.
排除标准
- •Recurrent stroke，subarachnoid hemorrhage, brain tumors patients;
- •Contraindication to undergo a 3T MR imaging;
- •Claustrophobia;
- •Have severe heart, hepatic or renal failure;
- •Don' t cooperate with the treatment;
- •Have participated in other clinical trails recently.
研究组 & 干预措施
Treatment Group A
Abdominal acupuncture and upper limb rehabilitation training
干预措施: Abdominal acupuncture (Other)
Treatment Group B
Sham abdominal acupuncture and upper limb rehabilitation training
干预措施: Sham abdominal acupuncture (Other)
Control Group
Upper limb rehabilitation only
结局指标
主要结局
Motor function of muscles
时间窗: SEMG will be tested before and after 4 weeks treatment,twice totally.
Common measures of sEMG will be tested. See the study protocol for details.
The integrity of the corticospinal tract
时间窗: Diffusion tensor imaging(DTI) will be tested before treatment and 4 weeks after treatment,twice totally.
The integrity of the corticospinal tract will be tested by diffusion trnsor imaging(DTI) of craniocerebral functional magnetic resonance imaging examination using magetic angiography to measure the changes caused by neuronal activity.We will observe the shape and integrity of the corticospinal tract.
次要结局
- Modified Barthel Index，MBI(Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.)
- Wolf Motor Function Test(Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.)
- Brunnstrom staging of upper limb movement(Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.)
- Fugl-Meyer Motor Assessment of upper limb(Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.)