An interventional study of Virtual reality gaming program (VR-gaming program) in Stroke, Stroke, Ischemic and Stroke Hemorrhagic, sponsored by University of British Columbia. Terminated at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-12-05.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
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.
Hypotheses: The investigators expect the protocol will demonstrate sufficient feasibility to support a subsequent larger randomized controlled trial (RCT). The investigators also hypothesize that the VR program will improve the primary endpoints, measures of mood, in people with stroke receiving inpatient rehabilitation, and that such improvements will reduce sedentary behaviour.
This 1-year feasibility study will use a parallel group, single-blinded (tester), randomized controlled trial that will be registered and adhere to the CONSORT guidelines. Eligible participants will be randomly assigned (1:1) to either: 1) Intervention: 3 times per week to discharge of VR-gaming; or 2) Control: usual care.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 28 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →University of British Columbia is the lead sponsor of 1,335 studies on the registry; 256 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Receives the VR protocol
Behavioral: Virtual reality gaming program (VR-gaming program)
Receives regular care
Participants in the VR-gaming program will receive three 20-30 minutes sessions of VR-gaming per week for the duration of their inpatient stay. Participants will select VR games/program in categories of: Relaxation; Leisure sport and activities; or Action/adventure. The VR-gaming program will be implemented one-on-one, face-to-face by a clinician using the commercially-available Oculus Go system.
Depressive symptoms
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
Time frame: Rehabilitation discharge (generally 4-6 weeks)
Anxiety symptoms
The 7-item Anxiety scale in the Hospital Anxiety and Depression Scale; total sub scale scores range from 0 to 21; higher values indicate more anxiety symptoms
Time frame: Rehabilitation discharge (generally 4-6 weeks)
Stress
10-item Perceived Stress Scale; total scores range from 0 to 40; higher values indicate higher perceived stress
Time frame: Rehabilitation discharge (generally 4-6 weeks)
Motivation
16-item Situational Motivation Scale, including 4 sub scales: 4-item Instrinsic motivation; 4-item Identified regulation; 4-item External motivation; 4-item Amotivation; Mean sub scale scores are derived, ranging from 1 to 7; higher values indicate higher motivation for each sub scale
Time frame: Rehabilitation discharge (generally 4-6 weeks)
Happiness
4-item Subjective Happiness Scale; Mean scores range from 1 to 7; higher values indicate higher happiness
Time frame: Rehabilitation discharge (generally 4-6 weeks)
Stroke severity (functional disability)
6-category Modified Ranking Scale; individuals are categorized into one of six categories, ranging from 'no disability = 0' to 'severe disability = 5'. A higher category ranking is indicative of greater disability
Time frame: Rehabilitation discharge (generally 4-6 weeks)
Sedentary time
7-item Measure of Older Adults' Sedentary Time; for each item (i.e., sedentary behaviour (e.g., watching tv)), participants estimate the amount of time in that activity in hours and minutes for the past week; total time is summed for an estimated sedentary behaviour for the past week
Time frame: Rehabilitation discharge (generally 4-6 weeks)
Feasibility indicator - recruitment rate
Number of participants recruited per week
Time frame: Rehabilitation discharge (generally 4-6 weeks)
Feasibility indicator - retention rate
Number of participants that complete the study, relative to the number that started the study
Time frame: Rehabilitation discharge (generally 4-6 weeks)
Feasibility indicator - perceived benefit of the VR Training Program,
17-item study specific Satisfaction survey; Mean scores range from 1 to 5; Higher scores indicate greater satisfaction
Time frame: Rehabilitation discharge (generally 4-6 weeks)
Feasibility indicators - treatment fidelity
Percentage of participants that participate in ALL VR Training sessions
Time frame: Rehabilitation discharge (generally 4-6 weeks)
Feasibility indicators - participant and tester burden
Percentage of participants that complete a data collection session in 60 minutes or less
Time frame: Rehabilitation discharge (generally 4-6 weeks)
Feasibility indicators - trainer burden
Time spent administering each VR session
Time frame: Rehabilitation discharge (generally 4-6 weeks)
Feasibility indicators - ease of using equipment
Downtime due to technical difficulties
Time frame: Rehabilitation discharge (generally 4-6 weeks)
Feasibility indicators - safety
Number of adverse events due to the VR Training program
Time frame: Rehabilitation discharge (generally 4-6 weeks)
Ran from Aug 2019 to primary completion in Apr 2022, 32 months.
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This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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