简体中文|English
检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
Efficacy of biofeedback-controlled game-based swallowing training (BGBST) in stroke survivors
下载XML文档

注册号：

Registration number：

 ChiCTR2100053979 

最近更新日期：

Date of Last Refreshed on：

 2022-11-05 19:33:16 

注册时间：

Date of Registration：

 2021-12-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

葉志剛 

研究负责人：

葉志剛 

Applicant：

YIP CHI KONG Calvin 

Study leader：

YIP CHI KONG Calvin 

申请注册联系人电话：

Applicant telephone：

 +852 34686780

研究负责人电话：

Study leader's
telephone：

+852 34686780

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 calvinyip@twc.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 calvinyip@twc.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

香港旺角山东街 98号钟秦兰凤大楼 2201C

研究负责人通讯地址：

香港旺角山东街 98号钟秦兰凤大楼 2201C

Applicant address：

Room 2201C, Cheung Chin Lan Hong Building, 98, Shantung Street, Mongkok, Hong Kong

Study leader's address：

Room 2201C, Cheung Chin Lan Hong Building, 98, Shantung Street, Mongkok, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

东华学院

Applicant's institution：

Tung Wah College

研究负责人所在单位：

东华学院

Affiliation of the Leader：

Tung Wah College

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 REC2019036

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Tung Wah College Research Ethics Committee

Name of the ethic committee：

Tung Wah College Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-04-07 00:00:00

伦理委员会联系人：

Professor Matthew Yau

Contact Name of the ethic committee：

Professor Matthew Yau

伦理委员会联系地址：

Research Ethics Committee, Research Office, Cheung Kung Hai Memorial Building, 90A, Mongkok, Hong Kong.

Contact Address of the ethic committee：

Research Ethics Committee, Research Office, Cheung Kung Hai Memorial Building, 90A, Mongkok, Hong Kong.

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

东华学院

Primary sponsor：

Tung Wah College

研究实施负责（组长）单位地址：

香港旺角山东街 98号钟秦兰凤大楼 16 楼 职业治疗实验室

Primary sponsor's address：

Room 16/F Occupational Therapy Lab. , Cheung Chin Lan Hong Building, 98, Shantung Street, Mongkok, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

香港

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

东华学院

具体地址：

香港旺角山东街 98号钟秦兰凤大楼

Institution
hospital：

Tung Wah College

Address：

Cheung Chin Lan Hong Building, 98, Shantung Street, Mongkok, Hong Kong

经费或物资来源：

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

Source(s) of funding：

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

研究疾病：

中风 患者  

Target disease：

Stroke

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

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.  

Objectives of Study：

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.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

BGBST is a game-based training which using the sEMG of the suprahyoid muscle group to control the game character to finish a task to achieve the muscle training. More effort from the suprahyoid muscle, more sEMG provided and to achieve a more difficult task in the game. Visual biofeedback is provided for the subjects to control the suprahyoid muscle group and thus also practice the safe swallowing techniques. The training protocol for BGBST is based on 80% of the peak amplitude of sEMG of suprahyoid group muscles to complete three set of task for 10 to 15 times per set at each training session, with a rest period of about 2 to 5 minutes between training sets. Each training session will require approximately 30 minutes. The subjects in the BGBST group will undergo three training sessions per week for 3 weeks, for a total of nine training sessions. 

纳入标准：

Inclusion criteria

排除标准：

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

Exclusion criteria：

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

研究实施时间：

Study execute time：

从 From 2021-01-01 00:00:00至 To 2022-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-12-05 00:00:00 至 To 2022-11-01 00:00:00

干预措施：

Interventions：

组别：

Group 1

样本量：

 36

Group：

Group 1

Sample size：

干预措施：

biofeedback game-based swallowing training (BGBST)

干预措施代码：

Intervention：

biofeedback game-based swallowing training (BGBST)

Intervention code：

组别：

Group 2

样本量：

 36

Group：

Group 2

Sample size：

干预措施：

Treatment as usual

干预措施代码：

Intervention：

Treatment as usual

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 香港 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 东华学院 

单位级别：

  

Institution
hospital：

Tung Wah College

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Surface electromyography (sEMG) during swallowing

指标类型：

主要指标

Outcome：

Surface electromyography (sEMG) during swallowing

Type：

Primary indicator

测量时间点：

Pre training, post training, 1 month and 3 month follow up

测量方法：

OMNI sEMG device

Measure time point of outcome：

Pre training, post training, 1 month and 3 month follow up

Measure method：

OMNI sEMG device

指标中文名：

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

指标类型：

主要指标

Outcome：

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

Type：

Primary indicator

测量时间点：

Pre training, post training, 1 month and 3 month follow up

测量方法：

Questionnaire

Measure time point of outcome：

Pre training, post training, 1 month and 3 month follow up

Measure method：

Questionnaire

指标中文名：

Swallowing Activity and Participation Profile (SAPP)

指标类型：

次要指标

Outcome：

Swallowing Activity and Participation Profile (SAPP)

Type：

Secondary indicator

测量时间点：

Pre training, post training, 1 month and 3 month follow up

测量方法：

Questionnaire

Measure time point of outcome：

Pre training, post training, 1 month and 3 month follow up

Measure method：

Questionnaire

指标中文名：

Swallowing Quality of Life Questionnaire (SWAL-QOL)V

指标类型：

次要指标

Outcome：

Swallowing Quality of Life Questionnaire (SWAL-QOL)V

Type：

Secondary indicator

测量时间点：

Pre training, post training, 1 month and 3 month follow up

测量方法：

Questionnaire

Measure time point of outcome：

Pre training, post training, 1 month and 3 month follow up

Measure method：

Questionnaire

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 20 岁 years
最大 Max age 100 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Random numbers will be generated by computer software, and based on the random number generated, the subjects will be randomly allocated into the training group (BGBST) or the control group (swallowing treatment as usual) based on permuted block of 4 randomization. The procedures will be done by the PI.

Randomization Procedure (please state who generates the random number sequence and by what method)：

Random numbers will be generated by computer software, and based on the random number generated, the subjects will be randomly allocated into the training group (BGBST) or the control group (swallowing treatment as usual) based on permuted block of 4 randomization. The procedures will be done by the PI.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

As the subjects will know and understand which treatment they received, it will not be possible for them to be blinded, but all assessments will be conducted by an independent trained research assistant or a trained undergraduate occupational therapy student; therefore, blinding of the assessor will be possible to prevent any possible bias.

Blinding：

As the subjects will know and understand which treatment they received, it will not be possible for them to be blinded, but all assessments will be conducted by an independent trained research assistant or a trained undergraduate occupational therapy student; therefore, blinding of the assessor will be possible to prevent any possible bias.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

contact the PI of the study

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

contact the PI of the study

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Data record form and encrypted computer data file

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data record form and encrypted computer data file

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-12-05 06:31:56
返回列表
欢迎访问WHO国际临床试验注册平台 Clinical Trials Hong Kong

中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

Copyright(c) (2005 - 2023) Chictr.org.cn.All rights reserved. 中国临床试验注册中心 版权所有

蜀ICP备16010396号-9

提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统