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临床试验/CTRI/2023/05/053184
CTRI/2023/05/053184招募中2 期

Task-based and Magnified Mirror Therapy for Unilateral Spatial Neglect among Post-Stroke Subjects: A Randomized Controlled Trial

ICMR1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2023年5月6日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
86
试验地点
1
主要终点
Fugl-Meyer Assessment

研究概览

简要总结

The proposed study would lead to a development of novel rehabilitation protocol for post stroke subjects with unilateral spatial neglect. The favorable change in the neglect may also enhance the motor recovery, especially the upper limb. The change would reduce the impact  of cognitive and functional disabilities and enhancing the quality of life.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • First episode of unilateral stroke (as defined by WHO)
  • Ischemic or hemorrhagic stroke
  • 1 to 36 months after the stroke onset
  • Hemiparesis (right or left) (as assessed by Fugl-Meyer assessment38 upper extremity subsection: 0 to 66)
  • USN (defined as an asymmetry between the Letter cancellation task omissions in the contralesional (left) and ipsilesional (right) visual field of at least 2 letters)
  • Normal visual abilities (with or without glasses)
  • Muscle tone: Modified Ashworth scale 1 to 2.

排除标准

  • 1.Receptive communication or other language disorder (which could interfere with the assessment and treatment process)
  • Severe other cognitive impairment (MMSE ≤ 17)
  • Homonymous Hemianopia.
  • Use of hand splinting or orthosis
  • Complex regional pain syndrome
  • Concomitant medical illness
  • Cardiovascular instability: resting systolic blood pressure >200mmHg and resting diastolic blood pressure >100 mmHg
  • Pregnancy
  • Renal infection or failure
  • Severe depression (Beck depression inventory > 30).

结局指标

主要结局

Fugl-Meyer Assessment

时间窗: Baseline, At 8 week (Post intervention), At 12 week (Follow-up)

次要结局

  • 1.Catherine Bergego Scale(2.Berg Balance Scale)

研究者

发起方
ICMR
申办方类型
Government funding agency

研究点 (1)

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