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【ChiCTR2100050850】Chau Pak Chun Janita：请与我们联系上传伦理审查文件 Effects of a social participation-focused virtual reality intervention on the physical, psychological and social outcomes of community-dwelli

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基本信息

登记号

ChiCTR2100050850

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2021-09-05

临床申请受理号

靶点

适应症

Stroke

试验通俗题目

Chau Pak Chun Janita：请与我们联系上传伦理审查文件 Effects of a social participation-focused virtual reality intervention on the physical, psychological and social outcomes of community-dwelli

试验专业题目

Effects of a social participation-focused virtual reality intervention on the physical, psychological and social outcomes of community-dwelling stroke survivors with physical disabilities

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

To develop and evaluate the effectiveness of a social participation-focused virtual reality (SP-VR) intervention on the physical, psychological, and social outcomes of community-dwelling stroke survivors with physical disabilities.

试验分类

试验类型

随机平行对照

试验分期

其它

随机化

Participants will be allocated to the study arms using permuted block randomisation with varying block sizes in a 1:1 ratio. This will maintain a good balance of participants and optimise allocation concealment throughout the recruitment period.

盲法

Not stated

试验项目经费来源

General Research Fund, Research Grant Council

试验范围

目标入组人数

276

实际入组人数

第一例入组时间

2021-10-01

试验终止时间

2023-12-31

是否属于一致性

入选标准

Participants will be recruited from the stroke units of three acute and one rehabilitation hospitals and three stroke nurss-led clinics in a single region. We will recruit 276 stroke survivor–caregiver dyads. The following inclusion criteria will be applied to the stroke survivors: 1. Aged >=18 years; 2. A diagnosis of ischaemic or haemorrhagic stroke resulting in physical disability; 3. Study entry within 6 months post-stroke; 4. The ability to remain in a sitting position with support; 5. A Montreal Cognitive Assessment score (HK-MOCA version) above the second percentile; 6. The absence of limb deformities and other neurological or musculoskeletal disorders; 7. Residence in the community. The study will include survivors of a first stroke and those with a history of stroke. Caregivers who provide most care to the survivor will also be included. Both members of the dyad must be able to communicate in Chinese.；

排除标准

Both members of the dyad will be excluded if they have 1. A psychiatric condition (e.g. symptoms of delusion or hallucinations); 2. A history of vestibular deficits or severe visual impairments; 3. Any seizure activity during the previous 6 months; 4. Difficulty in following instructions.；

研究者信息

研究负责人姓名

试验机构

N/A

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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