Effects of Repetitive Transcranial Magnetic Stimulation Combined With Mirror Therapy on Upper Limb Function in Patients With Stroke: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 69
- 主要终点
- Nine-hole peg test
研究概览
简要总结
Stroke patients often have long-term upper limb dysfunction. Currently, there is still no specific clinical treatment for nerve damage. After acute treatments of stroke, patients' motor ability can only improve by spontaneous recovery of brain and rehabilitation treatment.
Transcranial magnetic stimulation uses a magnetic field pulse generated by a coil outside the skull to pass through the skull. It uses the principle that magnetic electricity can generate currents, which activates nearby brain areas or changing the relationship between the left and right brains. Transcranial magnetic stimulation is a non-invasive, safe treatment.
Mirror therapy is an emerging rehabilitation method in recent years. As mirror therapy, therapists ask the patient to place the affected hand behind the mirror while looking at the image reflected by the unaffected upper limb. During mirror therapy, patients have to perform upper limb activities and imagine that the affected upper limb is performing the same action.
As mentioned above, transcranial magnetic stimulation and mirror therapy improve the recovery of stroke patients by two different ways. Currently, there are no studies that combine these two treatments. Therefore, our study hopes to initially explore the efficacy of transcranial magnetic stimulation and the efficacy of transcranial magnetic stimulation combined with mirror therapy.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 1 month after stroke
- •manual muscle strength < 5
排除标准
- •history of epilepsy
- •has other central nervous system diseases
- •has electric medication pump
- •has implant at inner ear
结局指标
主要结局
Nine-hole peg test
时间窗: week 0, week 6, week 12
Nine-hole peg test would be used to measure finger dexterity.
Fugl-Meyer Assessment (FMA) - upper extremity
时间窗: week 0, week 6, week 12
FMA would be recorded for evaluate patients' motor function of hand.
Action research arm test
时间窗: week 0, week 6, week 12
Action research arm test would be used to assess upper extremity performance including coordination, dexterity and functioning.
Box and block test
时间窗: week 0, week 6, week 12
Box and block test would be used to assess unilateral gross manual dexterity.
Functional independence measurement
时间窗: week 0, week 6, week 12
Functional independence measurement would be recorded to assess a patient's level of disability as well as a change in patient status in response to rehabilitation or medical intervention.
次要结局
未报告次要终点