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Audiovisual integrative training for augmenting cognitive- motor functions in older adults with mild cognitive impairment
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注册号：

Registration number：

 ChiCTR2000029408 

最近更新日期：

Date of Last Refreshed on：

 2020-01-30 13:21:22 

注册时间：

Date of Registration：

 2020-01-29 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Audiovisual integrative training for augmenting cognitive- motor functions in older adults with mild cognitive impairment

Public title：

Audiovisual integrative training for augmenting cognitive- motor functions in older adults with mild cognitive impairment

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Audiovisual integrative training for augmenting cognitive- motor functions in older adults with mild cognitive impairment

Scientific title：

Audiovisual integrative training for augmenting cognitive- motor functions in older adults with mild cognitive impairment

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：

Dr. Bess Yin-Hung Lam 

研究负责人：

Dr. Bess Yin-Hung Lam 

Applicant：

Dr. Bess Yin-Hung Lam 

Study leader：

Dr. Bess Yin-Hung Lam 

申请注册联系人电话：

Applicant telephone：

 +852 34008974

研究负责人电话：

Study leader's
telephone：

+852 34008974

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：

 yhbesslam@polyu.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 yhbesslam@polyu.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：

中國香港九龍紅磡育才道11號

研究负责人通讯地址：

中國香港九龍紅磡育才道11號

Applicant address：

TU506, Department of Rehabilitation Sciences, Hong Kong Polytechnic University, 11 Yucai Road, Hung Hom, Kowloon, Hong Kong, China

Study leader's address：

TU506, Department of Rehabilitation Sciences, Hong Kong Polytechnic University, 11 Yucai Road, Hung Hom, Kowloon, Hong Kong, China

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：

香港理工大學康復科學系

Applicant's institution：

Department of Rehabilitation Sciences, Hong Kong Polytechnic University

研究负责人所在单位：

香港理工大學康復科學系

Affiliation of the Leader：

Department of Rehabilitation Sciences, Hong Kong Polytechnic University

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：

 HSEARS20171220002

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：

香港理工大學康復科學系研究委員會人體研究分會

Name of the ethic committee：

Human Subjects Ethics Sub-committee, Department of Rehabilitation Sciences, Hong Kong Polytechnic University

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-01-08 00:00:00

伦理委员会联系人：

Professor Man Wai Kwong

Contact Name of the ethic committee：

Professor Man Wai Kwong

伦理委员会联系地址：

香港理工大學康復科學系

Contact Address of the ethic committee：

Department of Rehabilitation Sciences, Hong Kong Polytechnic University

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：

Dr. Bess Yin-Hung Lam

Primary sponsor：

Dr. Bess Yin-Hung Lam

研究实施负责（组长）单位地址：

中國香港九龍紅磡育才道11號香港理工大學康復科學系TU506

Primary sponsor's address：

TU506, Department of Rehabilitation Sciences, Hong Kong Polytechnic University

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong Special Administrative Region

City：

单位(医院)：

香港理工大學

具体地址：

九龍紅磡育才道11號

Institution
hospital：

Hong Kong Polytechnic University

Address：

Department of Rehabilitation Sciences, Hong Kong Polytechnic University

经费或物资来源：

Internal University Funding

Source(s) of funding：

Internal University Funding

研究疾病：

Mild Cognitive Impairment  

Target disease：

Mild Cognitive Impairment

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：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

析因分组（即根据危险因素或暴露因素分组） 

Study design：

Factorial 

研究目的：

This study aimed to adapt the AV integrative approach to examine the effectiveness of a training program to improve functions in older adults, specifically those with mild cognitive impairment (MCI) who have cognitive decline (e.g., attention and executive functions). It was hypothesized that older adults with MCI have more significant improvements in their at-tentional control and upper limb motor functions concurrently undergoing AV integrative training when compared with those healthy controls.  

Objectives of Study：

This study aimed to adapt the AV integrative approach to examine the effectiveness of a training program to improve functions in older adults, specifically those with mild cognitive impairment (MCI) who have cognitive decline (e.g., attention and executive functions). It was hypothesized that older adults with MCI have more significant improvements in their at-tentional control and upper limb motor functions concurrently undergoing AV integrative training when compared with those healthy controls.

药物成份或治疗方案详述：

Participants were asked to complete three sessions of AV integrative training within a week. Each session lasted for 2 hours (a total of 6 hours for the entire AV integrative training). The Taiko video game was adopted for the AV integrative training in this study. Specifically, the participants learnt to play a Taiko drum (Japa-nese percussion instrument) according to the songs chosen through the Playstation 4 rhythm game entitled Taiko no Tatsujin. Noises were added to the visual and auditory stimuli given that the use of 100% clear stimuli might contribute to inverse effectiveness. The input device used was a simulated electronic Taiko. This Taiko video game training involved hitting the drum with two drumsticks, one for each hand. Specifically, with each piece of chosen song playing in the background, the circular cues moving through a target zone were displayed on a computer screen. The participants were required to make precisely timed motor responses as accurately as possible by hitting the drum when the circular cues displayed on the screen fell into the target zone. If the cue displayed was red, then the participants had to hit the centre of the drum while the rim of the drum should be hit if the cue was blue.Training was administered and monitored by the occupational therapy trainees. Ethics approval was obtained from the Hong Kong Polytechnic University and written in-formed consent was obtained from each participant. The demographic information of the par-ticipants was collected and they were asked to complete the following assessments at the baseline and post-training. 

Description for medicine or protocol of treatment in detail：

Participants were asked to complete three sessions of AV integrative training within a week. Each session lasted for 2 hours (a total of 6 hours for the entire AV integrative training). The Taiko video game was adopted for the AV integrative training in this study. Specifically, the participants learnt to play a Taiko drum (Japa-nese percussion instrument) according to the songs chosen through the Playstation 4 rhythm game entitled Taiko no Tatsujin. Noises were added to the visual and auditory stimuli given that the use of 100% clear stimuli might contribute to inverse effectiveness. The input device used was a simulated electronic Taiko. This Taiko video game training involved hitting the drum with two drumsticks, one for each hand. Specifically, with each piece of chosen song playing in the background, the circular cues moving through a target zone were displayed on a computer screen. The participants were required to make precisely timed motor responses as accurately as possible by hitting the drum when the circular cues displayed on the screen fell into the target zone. If the cue displayed was red, then the participants had to hit the centre of the drum while the rim of the drum should be hit if the cue was blue.Training was administered and monitored by the occupational therapy trainees. Ethics approval was obtained from the Hong Kong Polytechnic University and written in-formed consent was obtained from each participant. The demographic information of the par-ticipants was collected and they were asked to complete the following assessments at the baseline and post-training. 

纳入标准：

Inclusion criteria

排除标准：

All participants who received musical instrument training for three months or longer and were diagnosed with any major physical illness, mental disorder, or other disability.

Exclusion criteria：

All participants who received musical instrument training for three months or longer and were diagnosed with any major physical illness, mental disorder, or other disability.

研究实施时间：

Study execute time：

从 From 2018-05-14 00:00:00至 To 2018-05-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2018-02-01 00:00:00 至 To 2018-03-31 00:00:00

干预措施：

Interventions：

组别：

MCI participants

样本量：

 10

Group：

MCI participants

Sample size：

干预措施：

AV integrative training

干预措施代码：

Intervention：

AV integrative training

Intervention code：

组别：

Healthy control participants

样本量：

 10

Group：

Healthy control participants

Sample size：

干预措施：

AV integrative training

干预措施代码：

Intervention：

AV integrative training

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Department of Rehabilitation Sciences, Hong Kong Polytechnic University 

单位级别：

 三级医院 

Institution
hospital：

Department of Rehabilitation Sciences, Hong Kong Polytechnic University

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Executive function

指标类型：

主要指标

Outcome：

Executive function

Type：

Primary indicator

测量时间点：

Baseline and Post-training

测量方法：

Stroop Test

Measure time point of outcome：

Baseline and Post-training

Measure method：

Stroop Test

指标中文名：

Upper limb motor function

指标类型：

主要指标

Outcome：

Upper limb motor function

Type：

Primary indicator

测量时间点：

Baseline and Post-training

测量方法：

Purdue Pegboard Test

Measure time point of outcome：

Baseline and Post-training

Measure method：

Purdue Pegboard Test

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

N/A

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

This was a single arm and no randomization was performed because the categorization of participants into MCI or healthy control groups was based on their MoCA scores.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Nil

Blinding：

Nil

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）：

Available upon request

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

Available upon request

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：

The data collected would be managed by the project principal investigators and the data would only be processed and analyzed by the research team.

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

The data collected would be managed by the project principal investigators and the data would only be processed and analyzed by the research team.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-01-30 13:21:22
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