NCT01828398已完成2 期
tDCS and Robotic Therapy in Stroke
University Hospital of Ferrara1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Upper Extremity
研究概览
简要总结
After stroke a limited motor recovery in the paretic upper limb accounts for a large proportion of the disabling sequelae. Only about 15% of those with initial complete upper limb paralysis after stroke recover functional use of their impaired arm in daily life.
The aim of this study is to test the effects of tDCS combined with upper extremity robot-assisted therapy on stroke survivors.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females subjects. Age > 18 years.
- •Diagnosis of first ischemic stroke
- •Impairment of the upper limb
- •Trunk control defined in the Trunk-Control Test (TCT), with a score > 50.
排除标准
- •anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test
- •Impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
- •contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
- •Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current
- •Neurological or psychiatric pathology
- •severe cardio-pulmonary, renal, hepatic diseases
- •Pregnancy
结局指标
主要结局
Fugl-Meyer Upper Extremity
时间窗: A week prior to treatment beginning
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.
次要结局
- Assessment of cortical excitability (TMS)(A week prior to treatment beginning)
- Box and Block Test(A week prior to treatment beginning)
- Ashworth Modified Scale(A week prior to treatment beginning)
- Motor Activity Log (MAL)(A week prior to treatment beginning)
研究者
Sofia Straudi, MD
MD
University Hospital of Ferrara
研究点 (1)
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