The Effect of High Frequency Repetetive Transcranial Magnetic Stimulation on Motor Recovery and Gait Parameters in Patients With Chronic Incomplete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- The lower extremity motor scores of the patients
研究概览
简要总结
It is postulated that high frequency repetitive transcranial magnetic stimulation (rTMS) can decrease the corticospinal inhibition and enhance the motor recovery. This study is aimed to investigate the effect of high frequency rTMS on lower extremity motor recovery and gait parameters in patients with chronic motor incomplete traumatic spinal cord injury (SCI).
详细描述
A sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (>1 year) motor incomplete traumatic SCI were randomized into real rTMS group (n=14) or sham rTMS group (n=14). Real rTMS (20 Hz, a total of 1600 stimuli) or sham r TMS were applied in the motor cortex area of lower extremities during 3 weeks (15 sessions). In addition to rTMS sessions, patients underwent a rehabilitation program including exercises for strengthening, walking and balance. Lower extremity motor score (LEMS), the temporal-spatial gait parameters measured by 3D gait analysis, Walking Index for SCI-II (WISCI-II) scale and 10 meters walking test were assessed at baseline, 3 weeks (after the treatment sessions) and 5 weeks (follow-up).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the diagnosis of motor incomplete cervical or thoracic spinal cord injury (ASIA C or D), spinal cord injury due to trauma at least one year previously
- •the ability to walk at least 10 meters independently or with assisted devices such as cane / canadian, age (18-45 years). All participants signed the informed consent form.
排除标准
- •the presence of other musculoskeletal or neurological diseases that may prevent walking, lower motor neuron lesion (cauda equina and conus medullaris)
- •family history of epilepsy
- •the presence of brain injury
- •the presence of cranium defect
- •the presence of pacemaker
- •pregnancy
结局指标
主要结局
The lower extremity motor scores of the patients
时间窗: through study completion, an average of 2 weeks (Change from Baseline The lower extremity motor scores of the patients at 2 weeks.)
The lower extremity motor scores of the patients (degree of muscle strength according to the American Spinal Injury Association (ASIA) Impairment Scale )(The assesment of ASIA scale includes 5 classification as ASIA A, B,C,D,E. ASIA A is the worst score and ASIA E is the best score)
次要结局
- Walking Index for SCI - II (WISCI-II) Scale(through study completion, an average of 2 weeks (Change from Baseline WISCI II scale scores of the patients at 2 weeks.))
- the parameters of gait analysis - single support time(through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.))
- the parameters of gait analysis - walking speed(through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.))
- the parameters of gait analysis - cadence(through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.))
- the parameters of gait analysis - double support time(through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.))
- 10-meter Gait Test(through study completion, an average of 2 weeks (Change from Baseline 10 meter gait test scores of the patients at 2 weeks.))
- the parameters of gait analysis - contralateral foot contact time(through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.))
- the parameters of gait analysis - step time(through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.))
- the parameters of gait analysis - step speed(through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.))
研究者
Yasin Demir
Physical Medicine and Rehabilitation Specialist
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital