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临床试验/NCT01405378
NCT01405378已完成早期 1 期

Combining Transcranial Direct Current Stimulation (tDCS) With Robot Therapy for the Impaired Upper Limb in Stroke Rehabilitation.

University of Southampton2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
23
试验地点
2
主要终点
Report change in upper limb function from baseline to 8 weeks and 3 months after treatment

研究概览

简要总结

Every five minutes someone in the UK has a stroke. It is the main cause of long-term disability among adults in the UK despite a fall in age-specific stroke incidence, with a growing number of survivors remaining dependent for activities of daily living. While most people with stroke regain walking ability, upper limb problems with no voluntary arm and hand activity, affecting a third of people after stroke, has a poor prognosis. Transcranial direct current stimulation (tDCS) is a non-invasive procedure used to polarise brain regions through the application of weak direct currents and has the potential to develop into a useful aid to treatment strategies in neurorehabilitation. Recent literature into the application of tDCS in people with arm and hand impairments after stroke has shown promising results on upper limb function measures like the Jebsen-Taylor hand function test. Furthermore, a recent pilot study evaluated a six-week training programme combining tDCS with robot-assisted hand training and reported significant improvements in upper limb function. However, the robot in the latter study focused on single-plane distal movements only and long-term effects of the tDCS were not assessed. Recent robotic developments included robots with three rotational degrees-of-freedom for the upper limb, but the effectiveness of this type of robot combined with tDCS in early stroke settings is unknown. Ethical Approval was sought from NHS NRES Committee South Central- Southampton B (Ref: 11/SC/0345) to conduct this study.

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, Outcomes Assessor)

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

入选标准

  • Have a confirmed clinical diagnosis of a haemorrhagic or an ischaemic stroke confirmed clinically or by CT, PET or MRI Scan
  • Experienced a single (first) stroke or multiple strokes
  • In the acute, sub-acute or chronic phase of their recovery (the first three to seven days are referred to as the acute phase. The first two weeks to six months are defined as the sub-acute phase, and the chronic phase begins after three or six months (Teismann et al. 2011, Duncan et al. 2003a)
  • Have had a subcortical or cortical stroke
  • Be over the age of 18 years
  • Have any level of upper limb impairment

排除标准

  • A history of epilepsy (TMS studies) due to the fact that TMS could cause an epileptic fit
  • Impaired gross cognitive function; score of less than 24 of the Mini-Mental State Examination (Folstein et al. 1975)
  • Any metal implants in the head including cochlear implants
  • Any another neurological condition apart from stroke
  • Are currently participants in another intervention study using TMS/tDCS

结局指标

主要结局

Report change in upper limb function from baseline to 8 weeks and 3 months after treatment

时间窗: Will be used, exactly before commencing training programme (day 1), at the end of the 8 week training programme and at 3 months follow-up

Measures sensorimotor function of the upper limb (Sanford et al. 1993; Fugl-Meyer et al. 1975)

次要结局

  • Report change in cortical excitability from baseline to 8 weeks and 3 months after treatment(Will be used, exactly before commencing training programme (day 1), at the end of the 8 week training programme and at 3 months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jane Burridge, PhD

Professor

University of Southampton

研究点 (2)

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