The Effect of rTMS and tDCS Treatments Combined With Robotic Rehabilitation on Gait and Motor Recovery in Partial Chronic Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Walking Index for SCI - II (WISCI-II)
研究概览
简要总结
The purpose of this study is to assess the effect of rTMS and tDCS combined with robotic therapy on motor functional recovery and gait parameters
详细描述
After being informed about study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility requirements will be randomized into four groups in a 1:1 ratio to active rTMS, sham rTMS, active tDCS and sham tDCS.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having traumatic SCI
- •Between 6 months and 2 years after SCI
- •18-65 years old
- •Signing an informed consent form showing his/her consent to participate in the study.
- •Motor incomplete cervical or thoracic SCI
- •Spasticity in the lower extremity ≤2 according to the Modified Ashworth Scale
排除标准
- •History of epilepsy
- •A cardiac pacemaker
- •Pregnancy
- •Neurological diseases other than SCI
- •Metallic implant in brain or scalp (including cochlear implant)
- •Previous brain surgery
- •Orthopedic disease that prevents lower extremity movements
- •Diagnosis of malignancy
- •Receiving robotic /TMS/tDCS treatments in the last 6 months
结局指标
主要结局
Walking Index for SCI - II (WISCI-II)
时间窗: initial, 3th week 9th week changes
Physical limitation for walking secondary to impairment is defined at the person level and indicates the ability of a person to walk after spinal cord injury. The development of this assessment index required a rank ordering along a dimension of impairment, from the level of most severe impairment (0) to least severe impairment (20) based on the use of devices, braces and physical assistance of one or more persons. The order of the levels suggests each successive level is a less impaired level than the former. The ranking of severity is based on the severity of the impairment and not on functional independence in the environment.
Lower extremity motor scores according to ASIA examination
时间窗: initial, 3th week 9th week changes
ASIA (American Spinal Injury Association) Classification System is used to assess and determine the neurological status of individuals with spinal cord injuries. This classification system consists of five different classes: ASIA A:There is complete loss of motor and sensory function. ASIA B:Sensation is present in the sacral region (S4-S5), but motor function loss persists. ASIA C:Motor function loss persists, but there is observable muscle contraction (muscle strength) in specific muscle groups. ASIA D:Motor function loss continues, but uncontrolled movements can be observed. ASIA E:Normal sensory and motor functions are present. The ASIA classification is a widely used system for evaluating the severity and effects of spinal cord injuries. This classification provides important guidance for the planning of treatment and rehabilitation processes.
10 meter walking test
时间窗: initial, 3th week 9th week changes
The 10 Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance\[1\]. It can be employed to determine functional mobility and gait.
次要结局
- Visual Analogue Scale(initial, 3th week 9th week changes)
- Modified Ashworth Scale(initial, 3th week 9th week changes)
研究者
Emre Adıgüzel
Emre Adıgüzel, Associate professor, Ankara City Hospital Bilkent
Ankara City Hospital Bilkent