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临床试验/ChiCTR2100053979
ChiCTR2100053979招募中Unknown

Efficacy of biofeedback-controlled game-based swallowing training (BGBST) in stroke survivors

Faculty Development Scheme (FDS), The Research Grants Council, University Grants Committee, Hong Kong SAR.1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年1月1日最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
72
试验地点
1
主要终点
Surface electromyography (sEMG) during swallowing

研究概览

简要总结

The study will evaluate the efficacy of biofeedback game-based swallowing training (BGBST) in subjects with post stroke dysphagia in terms of swallowing strength, participation and quality compared to the control subjects after training and at the 3-month follow-up visit.

研究设计

研究类型
Interventional
主要目的
随机平行对照
盲法
None

入排标准

年龄范围
20 至 100(—)
性别
All

入选标准

  • Suffered from Stroke;
  • Score above 3 on EAT-10 scale or use thickener in feeding;
  • Ability to follow instructions well;
  • Have active control of swallowing;
  • Willingness to give written consent;
  • Ability to communicate and give verbal feedback.

排除标准

  • Tube feeding;
  • Inability to follow instructions;
  • Inability to give written consent;
  • Involuntary movement over head and neck regions; severe visual impairment.

研究组 & 干预措施

Group 1

biofeedback game-based swallowing training (BGBST)

Group 2

Treatment as usual

结局指标

主要结局

Surface electromyography (sEMG) during swallowing

时间窗: Pre training, post training, 1 month and 3 month follow up

Eating Assessment Tool 10-item version (EAT-10)

时间窗: Pre training, post training, 1 month and 3 month follow up

次要结局

  • Swallowing Activity and Participation Profile (SAPP)(Pre training, post training, 1 month and 3 month follow up)
  • Swallowing Quality of Life Questionnaire (SWAL-QOL)V(Pre training, post training, 1 month and 3 month follow up)

研究者

发起方
Faculty Development Scheme (FDS), The Research Grants Council, University Grants Committee, Hong Kong SAR.

研究点 (1)

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