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临床试验/NCT04011202
NCT04011202终止不适用

Virtual Reality, Mood, and Sedentary Behaviour After Stroke

University of British Columbia1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年8月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
28
试验地点
1
主要终点
Depressive symptoms

研究概览

简要总结

The purpose of this study is to: 1) evaluate the feasibility (e.g. recruitment and retention, administrative and participant burden) of a VR program to improve mood and sedentary behaviour in inpatient stroke survivors; and 2) develop an understanding of the effects of VR on mood and sedentary behaviours among inpatient stroke survivors.

详细描述

It is common for individuals who have had a stroke to have deficits in motor and sensory function, communication, and cognition. These deficits pose serious barriers for stroke survivors to effectively manage their health and well-being over time, and has contributed to excessive amounts of sedentary time beginning in inpatient rehabilitation, and continuing post-discharge.

Sedentary behaviours are associated with various health risks. Lying down, sitting for prolonged periods of time, or any other activity with an energy expenditure of ≤1.5 metabolic equivalent units are associated with an increased incident of chronic diseases, as well as with reduced physical function, and increased symptoms of depression and frailty. Moreover, sedentary behaviours are associated with all-cause mortality, with each additional hour spent sedentary increasing mortality risk. Thus, efforts to reduce sedentary time as inpatients may be a promising therapeutic intervention to improve longer term health outcomes of stroke survivors.

Issues with mood after stroke are common. After stroke, depression and depressive symptoms are common occurrences with as many as 28% experiencing depressive disorders or symptoms one month post-stroke, and 36% between two and five months. Similarly, anxiety symptoms and psychological stress are prevalent issues, with 23% reporting anxiety within five months post stroke, and 25% experiencing psychological stress. Not only are these issues associated with reduced quality of life, poorer functional outcomes after rehabilitation, increased healthcare use, and mortality, these psychological factors have also been shown to be associated with sedentary behaviour. It is therefore plausible that decreases in sedentary behaviours may be achieved via mood improvements.

Virtual reality (VR) has garnered substantial attention as a cost-effective treatment approach in stroke rehabilitation, particularly as a means to supplement existing therapy. While the use of VR in stroke rehabilitation has resulted in positive outcomes, the outcomes studied have primarily focused on physical and functional rehabilitation. Despite evidence that VR is emerging as a method to address issues with mood, the use of VR to improve mood among inpatient stroke survivors has yet to be studied.

Objectives: In this research, the investigators will: 1) evaluate the feasibility (e.g. recruitment and retention, administrative and participant burden) of a VR program to improve mood and sedentary behaviour in inpatient stroke survivors; and 2) develop an understanding of the effects of VR on mood and sedentary behaviours among inpatient stroke survivors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Have had a stroke (confirmed by CT scan or MRI); are an inpatient receiving stroke rehabilitation for an expected length of stay of 14 days or longer; are at least 19 years of age or older; are able to provide informed consent; have clearance from a physician to participate in the study; are able to understand English.

排除标准

  • •Have a visual or hearing impairment; have a planned surgical intervention; are not medically stable; have a significant musculoskeletal or other neurological condition; severe aphasia.

研究组 & 干预措施

VR Group

Experimental

Receives the VR protocol

干预措施: Virtual reality gaming program (VR-gaming program) (Behavioral)

Control Group

No Intervention

Receives regular care

结局指标

主要结局

Depressive symptoms

时间窗: Rehabilitation discharge (generally 4-6 weeks)

The 7-item Depression scale in the Hospital Anxiety and Depression Scale; total sub scale scores range from 0 to 21; higher values indicate more depressive symptoms

次要结局

  • Stress(Rehabilitation discharge (generally 4-6 weeks))
  • Sedentary time(Rehabilitation discharge (generally 4-6 weeks))
  • Motivation(Rehabilitation discharge (generally 4-6 weeks))
  • Happiness(Rehabilitation discharge (generally 4-6 weeks))
  • Stroke severity (functional disability)(Rehabilitation discharge (generally 4-6 weeks))
  • Anxiety symptoms(Rehabilitation discharge (generally 4-6 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brodie Sakakibara

Assistant Professor

University of British Columbia

研究点 (1)

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