Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke Stroke, Ischemic Stroke Hemorrhagic Stroke, Lacunar | Behavioral: Virtual reality gaming program (VR-gaming program) | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Control group and experimental group |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Virtual Reality, Mood, and Sedentary Behaviour After Stroke |
Actual Study Start Date : | August 21, 2019 |
Estimated Primary Completion Date : | April 30, 2022 |
Estimated Study Completion Date : | July 31, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: VR Group
Receives the VR protocol
|
Behavioral: Virtual reality gaming program (VR-gaming program)
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.
|
No Intervention: Control Group
Receives regular care
|
Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Brodie Sakakibara, PhD | 250 807 8505 | brodie.sakakibara@ubc.ca |
Canada, British Columbia | |
Kelowna General Hospital | Recruiting |
Kelowna, British Columbia, Canada, V1Y 1T2 | |
Contact: Megan Helgason, BScPT | |
Principal Investigator: Megan Helgason, BScPT | |
Sub-Investigator: Lindsay Mitchell, MSW | |
Sub-Investigator: Donna Jansons, MSW |
Principal Investigator: | Brodie Sakakibara | University of British Columbia |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | July 3, 2019 | ||||
First Posted Date ICMJE | July 8, 2019 | ||||
Last Update Posted Date | May 24, 2021 | ||||
Actual Study Start Date ICMJE | August 21, 2019 | ||||
Estimated Primary Completion Date | April 30, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Depressive symptoms [ Time Frame: 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
|
||||
Original Primary Outcome Measures ICMJE |
Change from baseline depressive symptoms at 3-weeks, and 3-weeks post-hospital discharge. [ Time Frame: Baseline, 3-weeks, 3 weeks post-discharge ] 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
|
||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE |
|
||||
Current Other Pre-specified Outcome Measures |
|
||||
Original Other Pre-specified Outcome Measures |
|
||||
Descriptive Information | |||||
Brief Title ICMJE | Virtual Reality, Mood, and Sedentary Behaviour After Stroke | ||||
Official Title ICMJE | Virtual Reality, Mood, and Sedentary Behaviour After Stroke | ||||
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. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Control group and experimental group Masking: Single (Outcomes Assessor)Primary Purpose: Treatment |
||||
Condition ICMJE |
|
||||
Intervention ICMJE | Behavioral: Virtual reality gaming program (VR-gaming program)
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.
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE |
50 | ||||
Estimated Study Completion Date ICMJE | July 31, 2022 | ||||
Estimated Primary Completion Date | April 30, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 19 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
|
||||
Listed Location Countries ICMJE | Canada | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04011202 | ||||
Other Study ID Numbers ICMJE | VR Stroke | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Brodie Sakakibara, University of British Columbia | ||||
Study Sponsor ICMJE | University of British Columbia | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | University of British Columbia | ||||
Verification Date | May 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |