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临床试验/NCT05308667
NCT05308667已完成不适用

Effects of Intermittent Theta Burst Stimulation in Addition to Constraint-Induced Movement Therapy in Stroke Patients

Istanbul Medeniyet University2 个研究点 分布在 2 个国家目标入组 15 人开始时间: 2022年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
2
主要终点
Wolf-Motor Function Test

研究概览

简要总结

In recent studies, it has been reported that intermittent theta-burst stimulation (iTBS) provides additional benefits when applied in adjunct to the rehabilitation in all stages of stroke (acute, subacute, or chronic). In our study, it was aimed to evaluate the effectiveness of iTBS applied in addition to modified constraint-induced movement therapy (mCIMT). By doing so, we intend to increase patient adherence to neurorehabilitation and decrease the cost of rehabilitation.

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, Care Provider)

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

  • First time and unilateral stroke
  • 1-12 months after the incident
  • Getting 24 points or more in Mini Mental Status Examination
  • Being able to stand for 2 minutes without any help by using the upper extremity as a support tool when necessary.
  • Being a low-functioning patient according to the CIMT criteria: a) At least 10 degrees of active wrist extension starting from the angle of full flexion, b) 10 degrees of extension at the metacarpophalangeal and inter-phalangeal joints of at least 2 fingers

排除标准

  • those who score more than 2.5 points on the Motor Activity Log-28 scale,
  • who have severe pain in the upper extremity (5 and above on the Visual Analogue Scale) and spasticity (3 and above on the Modified Ashworth Scale), which may affect the treatment, and
  • Those who do not have adequate communication skills.
  • Patients who have visual problems

结局指标

主要结局

Wolf-Motor Function Test

时间窗: 45 minutes

It is a new time-based method to evaluate upper extremity performance while providing insight into joint-specific and total limb movements

Fugl-Meyer Assessment-Upper extremity

时间窗: 30 minutes

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and pain.

次要结局

  • Motor Evoked Potentials (MEPs)(10 minutes)

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esma Nur KOLBAŞI

Researcher

Istanbul Medeniyet University

研究点 (2)

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