Transcranial Direct Current Stimulation ASsociated With Physical-therapy In Acute Stroke Patients - the tDCS ASAP - a Randomized, Triple Blind, Sham-controlled Study ?
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Wolf Motor Function Test Change
研究概览
简要总结
Acute stroke patient will undergo one month (20 sessions) of physical therapy and anodal tDCS.
Patients will undergo functional outcomes measured at 48h post onset, 7,14,21,28 days, 3 and 6 months and one year post onset.
详细描述
Recruitment :
Patients with acute stroke (24-48h after stroke) who have upper and / or lower sensorimotor deficits
• Treatment : After being selected according to the inclusion and exclusion criteria of this study, patients will be randomized and placed in one of two groups: placebo (P) or transcranial anodic stimulation (A).
Once placed in one of two groups, patients will all receive intensive physiotherapy for functional improvement in order to increase motor, postural and motor control. This physiotherapy will be established 5 times a week (Monday to Friday).
In addition to physiotherapy, the patient will have electrodes placed on his head, attached via a system of straps, to deliver either a continuous current (A) or no current (P) and at a rate of 5 times per week for 4 weeks. Neither the physiotherapist nor the patient will know what treatment he will have received.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The device is preprogrammed by a third party non participating in any element in the study. They then chose (using opaque envelopes) the treatment code for each participant.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Woman or man
- •Between 18 and 80 years old
- •First ever stroke
- •Capable of signing the consent form
排除标准
- •One on the TSST (in high and relatively high risk sections)
- •Previous neurological or orthopedic pathologies affecting limbs
- •Cognitive deficits
研究组 & 干预措施
Anodal tDCS
Patients will receive 20min anodal tDCS
干预措施: tDCS (Device)
Sham tDCS
Patients will receive 20 minutes of Sham anodal tDCS
干预措施: tDCS (Device)
结局指标
主要结局
Wolf Motor Function Test Change
时间窗: 48 hours post onset, 7, 14, 21 and 28 days post onset, 3 and 6 months post onset and 1 year post onset
Functional outcome of the paretic limb
Semmes Weinstein Change
时间窗: 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset
Monofilament sensory test
Timed up and go Change
时间窗: 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset
walking test
10 meter walk test Change
时间窗: 48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset
Walking speed test
次要结局
- Trunk impairment scale Change(48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset)
- HADS Change(48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset)
- Fugl Meyer Change(48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset)
- Stroke impact scale Change(48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset)
- 4 square step test Change(48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset)
- Tardieu spasticity scale Change(48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset)
- Berg Balance scale Change(48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset)
- Postural assessement scale Change(48 hours post onset, days 7, 14, 21 and 28 post onset, 3 and 6 months post onset and 1 year post onset)
研究者
Bornheim Stephen
Assistant Professor
University of Liege