Clinical trial NCT04011202: Virtual Reality, Mood, and Sedentary Behaviour After Stroke
Official title: Virtual Reality, Mood, and Sedentary Behaviour After Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Stroke, Ischemic
Stroke Hemorrhagic
Stroke, Lacunar
Keywords: Stroke
Virtual reality
Depressive symptoms
Sedentary behaviour
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group and experimental group
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Depressive symptoms
timeFrame: Rehabilitation discharge (generally 4-6 weeks)
Secondary outcomes:
measure: Anxiety symptoms
timeFrame: Rehabilitation discharge (generally 4-6 weeks)
measure: Stress
timeFrame: Rehabilitation discharge (generally 4-6 weeks)
measure: Motivation
timeFrame: Rehabilitation discharge (generally 4-6 weeks)
measure: Happiness
timeFrame: Rehabilitation discharge (generally 4-6 weeks)
measure: Stroke severity (functional disability)
timeFrame: Rehabilitation discharge (generally 4-6 weeks)
measure: Sedentary time
timeFrame: Rehabilitation discharge (generally 4-6 weeks)
Other outcomes:
measure: Feasibility indicator - recruitment rate
timeFrame: Rehabilitation discharge (generally 4-6 weeks)
measure: Feasibility indicator - retention rate
timeFrame: Rehabilitation discharge (generally 4-6 weeks)
measure: Feasibility indicator - perceived benefit of the VR Training Program,
timeFrame: Rehabilitation discharge (generally 4-6 weeks)
measure: Feasibility indicators - treatment fidelity
timeFrame: Rehabilitation discharge (generally 4-6 weeks)
measure: Feasibility indicators - participant and tester burden
timeFrame: Rehabilitation discharge (generally 4-6 weeks)
measure: Feasibility indicators - trainer burden
timeFrame: Rehabilitation discharge (generally 4-6 weeks)
measure: Feasibility indicators - ease of using equipment
timeFrame: Rehabilitation discharge (generally 4-6 weeks)
measure: Feasibility indicators - safety
timeFrame: Rehabilitation discharge (generally 4-6 weeks)
Locations:
city: Kelowna
country: Canada
facility: Kelowna General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Brodie Sakakibara
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rash I, Helgason M, Jansons D, Mitchell L, Sakakibara BM. The influence of a virtual reality entertainment program on depressive symptoms and sedentary behaviour in inpatient stroke survivors: a research protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2022 Oct 22;8(1):230. doi: 10.1186/s40814-022-01189-8.