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临床试验/NCT02645344
NCT02645344已完成不适用

Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) Combined With Sensory Cueing (SC) on Unilateral Neglect in Subacute Patients With Right Hemispheric Stroke: A Randomized Controlled Study

The Hong Kong Polytechnic University0 个研究点目标入组 60 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Catherine Bergego Scale (CBS)

研究概览

简要总结

The objective was to compare the effects of repetitive Transcranial Magnetic Stimulation (rTMS) combined with sensory cueing (SC), rTMS alone, and conventional rehabilitation on reducing unilateral neglect (UN) and improving hemiplegic arm functions and performance of activities of daily living (ADL). Sixty subacute patients with left UN after right-hemispheric stroke were randomly assigned to three groups; rTMS combined with SC, rTMS alone, and conventional rehabilitation. rTMS at 1 Hz was applied over P5 of the contralesional hemisphere while vibration cueing was emitted using a wristwatch device on the hemiplegic arm, five days per week for two weeks. The first two groups received the same dosage of conventional rehabilitation on top of their experimental interventions. Blinded assessments were administered at baseline, 2 weeks postintervention, and four-week follow-up upon completion of training.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of right-hemispheric stroke
  • Duration since onset of more than one week
  • Presenting with unilateral neglect, confirmed by the conventional subtests of the BIT with cutoff scores of 129
  • First-ever stroke, or unilateral neglect as the consequence of the last stroke
  • Being aged 18 or over
  • Mini Mental State Examination score of ≥17
  • Giving written consent to participate.

排除标准

  • Duration since onset of stroke of more than six months
  • Medically unstable
  • Epileptic seizures, unconsciousness, or intracranial hypertension
  • Serious heart disease
  • Severe aphasia so as to have difficulty understanding the therapists' instructions
  • Metal implants in vivo

结局指标

主要结局

Catherine Bergego Scale (CBS)

时间窗: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)

Behavior Inattention Test (BIT)

时间窗: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)

次要结局

  • Fugl-Meyer Assessment (FMA)(Change from baseline in 4 weeks (baseline, 2-week and 2-week after training))
  • Action Research Arm Test (ARAT)(Change from baseline in 4 weeks (baseline, 2-week and 2-week after training))
  • Modified Barthel index (MBI)(Change from baseline in 4 weeks (baseline, 2-week and 2-week after training))

研究者

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

Kenneth N. K. Fong

Associate Professor

The Hong Kong Polytechnic University

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