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Use of Wii Sports based training to reduce the falls and improve quality of life in people diagnosed as Parkinson's disease
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注册号：

Registration number：

 ChiCTR2200057135 

最近更新日期：

Date of Last Refreshed on：

 2022-03-01 09:06:41 

注册时间：

Date of Registration：

 2022-03-01 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Use of Wii Sports based training to reduce the falls and improve quality of life in people diagnosed as Parkinson's disease

Public title：

Use of Wii Sports based training to reduce the falls and improve quality of life in people diagnosed as Parkinson's disease

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effectiveness of Wii Sports Training on Postural Stability, Fall and Quality of Life in Idiopathic Parkinson’s Disease.

Scientific title：

Effectiveness of Wii Sports Training on Postural Stability, Fall and Quality of Life in Idiopathic Parkinson’s Disease.

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：

Alagumoorthi Gandhisubramanian 

研究负责人：

Alagumoorthi Gandhisubramanian 

Applicant：

Alagumoorthi Gandhisubramanian 

Study leader：

Alagumoorthi Gandhisubramanian 

申请注册联系人电话：

Applicant telephone：

 +91 94 43070909

研究负责人电话：

Study leader's
telephone：

+91 94 43070909

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：

 kaviala37@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 kaviala37@gmail.com

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：

C 21, MIG Block, Pondicherry Housing Board Apartment, Suthanthira Ponvizha nagar, Pondicherry, India

研究负责人通讯地址：

C 21, MIG Block, Pondicherry Housing Board Apartment, Suthanthira Ponvizha nagar, Pondicherry, India

Applicant address：

C 21, MIG Block, Pondicherry Housing Board Apartment, Suthanthira Ponvizha nagar, Pondicherry, India

Study leader's address：

C 21, MIG Block, Pondicherry Housing Board Apartment, Suthanthira Ponvizha nagar, Pondicherry, India

申请注册联系人邮政编码：

Applicant postcode：

 605011

研究负责人邮政编码：

Study leader's postcode：

 605011

申请人所在单位：

印度1. Saveetha University, Chennai. 2. Mother Theresa Post Graduate and Research Institute of Health Sciences

Applicant's institution：

1. Saveetha University, Chennai. 2. Mother Theresa Post Graduate and Research Institute of Health Sciences

研究负责人所在单位：

印度1. Saveetha University, Chennai. 2. Mother Theresa Post Graduate and Research Institute of Health Sciences

Affiliation of the Leader：

1. Saveetha University, Chennai. 2. Mother Theresa Post Graduate and Research Institute of Health Sciences

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：

 001/02/2018/IEC/SMCH

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：

Saveetha Medical College Hospital, Saveetha University.

Name of the ethic committee：

Saveetha Medical College Hospital, Saveetha University.

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-02-13 00:00:00

伦理委员会联系人：

Director

Contact Name of the ethic committee：

Director

伦理委员会联系地址：

Department of Research, Saveetha University, Thandalam, Chennai, India

Contact Address of the ethic committee：

Department of Research, Saveetha University, Thandalam, Chennai, India

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：

Alagumoorthi Gandhisubramanian

Primary sponsor：

Alagumoorthi Gandhisubramanian

研究实施负责（组长）单位地址：

C 21, MIG Block, Pondicherry Housing Board Apartment, Suthanthira Ponvizha nagar, Pondicherry, India

Primary sponsor's address：

C 21, MIG Block, Pondicherry Housing Board Apartment, Suthanthira Ponvizha nagar, Pondicherry, India

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

印度

省(直辖市)：

Pondicherry

市(区县)：

Pondicherry

Country：

India

Province：

Pondicherry

City：

Pondicherry

单位(医院)：

Mother Theresa Post Graduate and Research Institute of Health Sciences

具体地址：

Indira nagar, Gorimedu, Pondicherry 605006

Institution
hospital：

Mother Theresa Post Graduate and Research Institute of Health Sciences

Address：

Indira nagar, Gorimedu, Pondicherry 605006

经费或物资来源：

nil

Source(s) of funding：

nil

研究疾病：

Parkinson's Disease  

Target disease：

Parkinson's Disease

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：

1.To find out the effectiveness of Wii Sports training in improving postural stability among PD patients. 2.To find out the effectiveness of Wii Sports training in reducing the incidence & rate of Fall 3.To find out the effectiveness of Wii Sports training in improving Quality of Life in Parkinson's Disease.  

Objectives of Study：

1.To find out the effectiveness of Wii Sports training in improving postural stability among PD patients. 2.To find out the effectiveness of Wii Sports training in reducing the incidence & rate of Fall 3.To find out the effectiveness of Wii Sports training in improving Quality of Life in Parkinson's Disease.

药物成份或治疗方案详述：

Description of treatment ?General Description: In this study Wii sports and Wii Sports resort will be used. For all the games, the participants have to wear the handheld remote (and Nunchuk for boxing) and stand at 10 feet distance in front of the screen, the sensitivity of the remote will be adjusted according to the instructions by the manufacturer. ?The participant will be explained about nature of the games and how to play the games. Before starting the study protocol, the participants will be encouraged to get familiar with the games for 2 days. ?Since they can play the games with limited movement of the upper extremity, the participants will be given clear instructions about the nature of the movement expected in each game as described in the tabular column. ?Games were categorized into plying 1) without changing the base of support or limited change in base of support (Boxing and Sword play), 2) with axial rotation of the trunk (baseball, Golf, Frisbee), 3) with stepping randomly front to back or side to side (table tennis and tennis), with larger displacement of CoM by taking steps (Bowling). ?The therapists will supervise while the participants playing the game and if necessary, they demonstrate the participant the right way of playing. ?Participant will play each game 2-3 minutes, totally 30-minutes each session excluding rest period, weekly 3 days and for 12 weeks. 

Description for medicine or protocol of treatment in detail：

Description of treatment ?General Description: In this study Wii sports and Wii Sports resort will be used. For all the games, the participants have to wear the handheld remote (and Nunchuk for boxing) and stand at 10 feet distance in front of the screen, the sensitivity of the remote will be adjusted according to the instructions by the manufacturer. ?The participant will be explained about nature of the games and how to play the games. Before starting the study protocol, the participants will be encouraged to get familiar with the games for 2 days. ?Since they can play the games with limited movement of the upper extremity, the participants will be given clear instructions about the nature of the movement expected in each game as described in the tabular column. ?Games were categorized into plying 1) without changing the base of support or limited change in base of support (Boxing and Sword play), 2) with axial rotation of the trunk (baseball, Golf, Frisbee), 3) with stepping randomly front to back or side to side (table tennis and tennis), with larger displacement of CoM by taking steps (Bowling). ?The therapists will supervise while the participants playing the game and if necessary, they demonstrate the participant the right way of playing. ?Participant will play each game 2-3 minutes, totally 30-minutes each session excluding rest period, weekly 3 days and for 12 weeks. 

纳入标准：

Inclusion criteria

排除标准：

No history of fall in the last 3 months
Severe cardiac disease where exercise is contraindicated
Severe dyskinesia which limits their participation in exercise protocol
polypharmacy with at least one fall risk drugs (CNS drugs, Diuretics)
Having any other Neurological / orthopedic Disorder - which affect their ability to participate in the exercise protocol
Uncontrolled Hyper / Hypo tension
marked visual (unable to recognize a face at a distance of 4 meter) or hearing deficit – which affect their ability to participate in the exercise protocol

Exclusion criteria：

No history of fall in the last 3 months
Severe cardiac disease where exercise is contraindicated
Severe dyskinesia which limits their participation in exercise protocol
polypharmacy with at least one fall risk drugs (CNS drugs, Diuretics)
Having any other Neurological / orthopedic Disorder - which affect their ability to participate in the exercise protocol
Uncontrolled Hyper / Hypo tension
marked visual (unable to recognize a face at a distance of 4 meter) or hearing deficit – which affect their ability to participate in the exercise protocol

研究实施时间：

Study execute time：

从 From 2018-04-04 00:00:00至 To 2020-01-21 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2018-04-04 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Experimental

样本量：

 96

Group：

Experimental

Sample size：

干预措施：

Wii Sports based training

干预措施代码：

Intervention：

Wii Sports based training

Intervention code：

组别：

Control

样本量：

 96

Group：

Control

Sample size：

干预措施：

Traditional Balance training

干预措施代码：

Intervention：

Traditional Balance training

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 印度

省(直辖市)：

 Pondicherry 

市(区县)：

 Pondicherry 

Country：

India

Province：

Pondicherry

City：

Pondicherry

单位(医院)：

 Indira Gandhi Government General Hospital and Post Graduate Institute 

单位级别：

 Tertiary Care 

Institution
hospital：

Indira Gandhi Government General Hospital and Post Graduate Institute

Level of the institution：

Tertiary Care

测量指标：

Outcomes：

指标中文名：

Fall incidence (number of faller / group)

指标类型：

主要指标

Outcome：

Fall incidence (number of faller / group)

Type：

Primary indicator

测量时间点：

Baseline, 12th week, 36th week

测量方法：

Fall Diary

Measure time point of outcome：

Baseline, 12th week, 36th week

Measure method：

Fall Diary

指标中文名：

Fall rate (number of fall / individual)

指标类型：

次要指标

Outcome：

Fall rate (number of fall / individual)

Type：

Secondary indicator

测量时间点：

Baseline, 12th week, 36th week

测量方法：

Fall Diary

Measure time point of outcome：

Baseline, 12th week, 36th week

Measure method：

Fall Diary

指标中文名：

Postural instability

指标类型：

次要指标

Outcome：

Postural instability

Type：

Secondary indicator

测量时间点：

Baseline, 12th week, 36th week

测量方法：

Berg Balance scale, Timed up and Go test

Measure time point of outcome：

Baseline, 12th week, 36th week

Measure method：

Berg Balance scale, Timed up and Go test

指标中文名：

Quality of life

指标类型：

次要指标

Outcome：

Quality of life

Type：

Secondary indicator

测量时间点：

Baseline, 12th week, 36th week

测量方法：

Parkinson's disease questionnaire 39

Measure time point of outcome：

Baseline, 12th week, 36th week

Measure method：

Parkinson's disease questionnaire 39

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 40 岁 years
最大 Max age 90 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）：

Principle Investigator generated random number in computer

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

Principle Investigator generated random number in computer

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：

Single Blind - assessor

Blinding：

Single Blind - assessor

是否共享原始数据：

IPD sharing

是Yes

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）：

as Xl file

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

as Xl file

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：

Collected data were entered in the Excel sheet and analyzed. No other electronic data management software were used.

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

Collected data were entered in the Excel sheet and analyzed. No other electronic data management software were used.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-03-01 09:06:41
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