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提醒治療法在半身痙攣學童的患側手部功能研究: 感知提示增強患側注意力或是配合密集運動, 哪樣較重要?
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注册号：

Registration number：

 ChiCTR1900021034 

最近更新日期：

Date of Last Refreshed on：

 2019-01-25 21:28:00 

注册时间：

Date of Registration：

 2018-12-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

提醒治療法在半身痙攣學童的患側手部功能研究: 感知提示增強患側注意力或是配合密集運動, 哪樣較重要?

Public title：

Which is essential in 'Remind to move' treatment in children with hemiplegic cerebral palsy: Awareness or a combination with intensive customized exercise?

注册题目简写：

English Acronym：

研究课题的正式科学名称：

提醒治療法在半身痙攣學童的患側手部功能研究: 感知提示增強患側注意力或是配合密集運動, 哪樣較重要?

Scientific title：

Which is essential in 'Remind to move' treatment in children with hemiplegic cerebral palsy: Awareness or a combination with intensive customized exercise?

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：

CUHK_CCRB00643

申请注册联系人：

Ka Ling Chan 

研究负责人：

Chan Ka Ling 

Applicant：

Ka Ling Chan 

Study leader：

Chan Ka Ling 

申请注册联系人电话：

Applicant telephone：

 +852 67341077

研究负责人电话：

Study leader's
telephone：

+852 67341077

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：

 chankaling22042003@yahoo.com.hk

研究负责人电子邮件：

Study leader's E-mail：

 1155105028@link.cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/635

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/635

申请注册联系人通讯地址：

Rm2204, Ying Yat House, Yat Tung Estate, Tung Chung, Hong Kong, China

研究负责人通讯地址：

Rm2204, Ying Yat House, Yat Tung Estate, Tung Chung, Hong Kong

Applicant address：

Rm2204, Ying Yat House, Yat Tung Estate, Tung Chung, Hong Kong, China

Study leader's address：

Rm2204, Ying Yat House, Yat Tung Estate, Tung Chung, 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：

香港中文大學

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

The Chinese University of Hong Kong

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：

 2018.470

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-11-30 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

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：

香港中文大學

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Rm2204, Ying Yat House, Yat Tung Estate, Tung Chung, Hong Kong, China

Primary sponsor's address：

Rm2204, Ying Yat House, Yat Tung Estate, Tung Chung, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

No

Source(s) of funding：

No

研究疾病：

半身痙攣  

Target disease：

Hemiplegic Cerebral Palsy

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：

 I期临床试验 

Study phase：

1

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

評估提醒治療法在半身痙攣學童患側手部功能的效果  

Objectives of Study：

To investigate: 1. whether continuously increasing awareness on the more affected arm by cueing it in the form of vibration at a fixed interval can improve hand functions and increase spontaneous hand use in hemiplegic arm; 2. whether providing sensory cueing to hemiplegic arm only can achieve c

药物成份或治疗方案详述：

Experimental group: Remind to move treatment was recently developed for children with hemiplegic cerebral palsy in Hong Kong to improve their hand functions and increase spontaneous hand use in the affected side. It is a user-friendly treatment which is easy and convenient to carry out without restraint of less affected hand as compared to CIMT. RTM involves two treatment elements: 1. sensory cueing on the affected arm 2.repetitive bimanual or unimanual upper limb exercise. A light weight sensory cueing wrist watch device was worn on the more affected arm in the children. It vibrated at fixed interval to increase the child’s attention on the hemiplegic arm, followed by repetitive upper limb exercise to increase use of it. The wristwatch will vibrate every 15 minutes during intervention period. The subjects will receive vibration and need to do individualized exercise afterwards. Control group: Interval vibration emitted by the sensory cueing wristwatch device on the affected hand of subjects. The wristwatch will vibrate every 15 minutes during intervention period. 

Description for medicine or protocol of treatment in detail：

Experimental group: Remind to move treatment was recently developed for children with hemiplegic cerebral palsy in Hong Kong to improve their hand functions and increase spontaneous hand use in the affected side. It is a user-friendly treatment which is easy and convenient to carry out without restraint of less affected hand as compared to CIMT. RTM involves two treatment elements: 1. sensory cueing on the affected arm 2.repetitive bimanual or unimanual upper limb exercise. A light weight sensory cueing wrist watch device was worn on the more affected arm in the children. It vibrated at fixed interval to increase the childs attention on the hemiplegic arm, followed by repetitive upper limb exercise to increase use of it. The wristwatch will vibrate every 15 minutes during intervention period. The subjects will receive vibration and need to do individualized exercise afterwards. Control group: Interval vibration emitted by the sensory cueing wristwatch device on the affected hand of subjects. The wristwatch will vibrate every 15 minutes during intervention period. 

纳入标准：

Inclusion criteria

排除标准：

1. severe cognitive impairment;
2. Severe visual impairment;
3. having predominant spasticity more than Grade 3 of the Modified Ashworth Scalein wrist and finger flexors, forearm pronators, and/or thumb adductors;
4. Severe sensory impairment that cannot sense the vibration emitted by the wristwatch device;
5. having received Botulinum neurotoxin injections and/or surgical interventions in the 6-month period before the study.

Exclusion criteria：

1. severe cognitive impairment;
2. Severe visual impairment;
3. having predominant spasticity more than Grade 3 of the Modified Ashworth Scalein wrist and finger flexors, forearm pronators, and/or thumb adductors;
4. Severe sensory impairment that cannot sense the vibration emitted by the wristwatch device;
5. having received Botulinum neurotoxin injections and/or surgical interventions in the 6-month period before the study.

研究实施时间：

Study execute time：

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

征募观察对象时间：

Recruiting time：

从 From 2018-12-17 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 12

Group：

Two groups

Sample size：

干预措施：

Vibration and exercise 3 weeks, around 6 hours/day, 5 days per week, in total 3 weeks versus Vibration 3 weeks, around 6 hours/day, 5 days per week, in total 3 weeks

干预措施代码：

Intervention：

Vibration and exercise 3 weeks, around 6 hours/day, 5 days per week, in total 3 weeks versus Vibration 3 weeks, around 6 hours/day, 5 days per week, in total 3 weeks

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)：

 香港中文大學 

单位级别：

 大學 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

hand functions

指标类型：

主要指标

Outcome：

hand functions

Type：

Primary indicator

测量时间点：

Pre-test, immediate post-test, post-test after 3 weeks of intervention

测量方法：

Bruininks Osteretsky Test of Motor Proficiency (2nd edition), Jebsen-Taylor Hand Function Test

Measure time point of outcome：

Pre-test, immediate post-test, post-test after 3 weeks of intervention

Measure method：

Bruininks Osteretsky Test of Motor Proficiency (2nd edition), Jebsen-Taylor Hand Function Test

指标中文名：

The upper limb impairment measures

指标类型：

主要指标

Outcome：

The upper limb impairment measures

Type：

Primary indicator

测量时间点：

Pre-test, immediate post-test, post-test after 3 weeks of intervention

测量方法：

include power grip and active range of motion on the affected upper limb

Measure time point of outcome：

Pre-test, immediate post-test, post-test after 3 weeks of intervention

Measure method：

include power grip and active range of motion on the affected upper limb

指标中文名：

Spontaneous use of affected hand in daily life

指标类型：

次要指标

Outcome：

Spontaneous use of affected hand in daily life

Type：

Secondary indicator

测量时间点：

Pre-test, immediate post-test, post-test after 3 weeks of intervention

测量方法：

the ratio of duration of movement of the affected hand to the duration of movement of the unaffected hand which is being measured by the built-in accelerator in the wristwatch device, Carergiver Functional Use Survey

Measure time point of outcome：

Pre-test, immediate post-test, post-test after 3 weeks of intervention

Measure method：

the ratio of duration of movement of the affected hand to the duration of movement of the unaffected hand which is being measured by the built-in accelerator in the wristwatch device, Carergiver Functional Use Survey

指标中文名：

Individual goal achievement

指标类型：

次要指标

Outcome：

Individual goal achievement

Type：

Secondary indicator

测量时间点：

Pre-test, immediate post-test, post-test after 3 weeks of intervention

测量方法：

EORTC QLQ-C30Goal Attainment Scaling

Measure time point of outcome：

Pre-test, immediate post-test, post-test after 3 weeks of intervention

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 6 岁 years
最大 Max age 18 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）：

Stratified randomization

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

Stratified randomization

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：

未说明

Blinding：

Not stated

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）：

未说明

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

Not stated

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：

未说明

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2019-01-25 21:28:00
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