Efficacy of a Task-oriented Circuit Training Associated With Transcranial Direct Current Stimulation (tDCS) for Gait Improvement in Chronic Stroke Patients . A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change from baseline in walking abilities, balance and mobility in Six minutes walking test (6MWT)
研究概览
简要总结
Stroke is one of the major causes of disability in the Western world. Initially gait is the most affected function, 80% of patients lose this ability.
Rehabilitation in stroke patients improves walking abilities in terms of gait and related gait activities, though six months after stroke many patients are significantly disabled.
Recently, a prospective study of 205 stroke patients showed that approximately 21% of patients have a significant decrease of mobility between the first and the third year after stroke. The main finding showed that inactivity was the most important factor for the mobility decline.
Evidence about effects of direct current brain stimulation on motor recovery function of lower limb are still little, some show that quadriceps strength after stimulation of damaged M1 area increased. Another study where tDCS was associated with robotic gait training did not report any effect compared to treatment alone. It is necessary to define if a different dosage of stimulation or the association of tDCS with gait training can improve walking and if further studies are required to investigate their effectiveness.
The aim of this clinical trial is to test the possibility of gait improvement through the association of tDCS with a specific task-oriented circuit training for walking abilities, balance and mobility.
详细描述
Inclusion criteria:
- Males and females subjects. Age > 18 years, <75 years.
- Diagnosis of first ischemic stroke > 6 months.
- Mini mental State Examination (MMSE) >24;
- Functional Ambulation Classification (FAC) higher or equal to 4
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females subjects. Age > 18 years, <75 years.
- •Diagnosis of first ischemic stroke > 6 months.
- •MMSE>24;
- •FAC higher or equal to 4
排除标准
- •Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current, presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants).
- •Neurological or psychiatric pathology.
- •Severe cardio-pulmonary, renal, hepatic diseases.
- •Pregnancy.
结局指标
主要结局
Change from baseline in walking abilities, balance and mobility in Six minutes walking test (6MWT)
时间窗: 1)A week prior to treatment beginning 2) the week after treatment end 3) three months follow up.
次要结局
- Fatigue Severity Scale (FSS)(1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.)
- Stroke Impact Scale (SIS) version 3.0(1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.)
- Stroke Specific Quality of Life (SS-QOL)(1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.)
- 10 meter walking test (test of 10m)(1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up)
- Timed "up and go" test (TUG)(1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.)
- Unified Balance Scale (UBS)(1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.)
研究者
Sofia Straudi, MD
Physical Medicine and Rehabilitation doctor
University Hospital of Ferrara