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Virtual Reality, Mood, and Sedentary Behaviour After Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011202
Recruitment Status : Suspended (Due to COVID-19)
First Posted : July 8, 2019
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Brodie Sakakibara, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Stroke Stroke, Ischemic Stroke Hemorrhagic Stroke, Lacunar Behavioral: Virtual reality gaming program (VR-gaming program) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 : November 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Depressive symptoms [ Time Frame: Rehabilitation discharge (generally 4-6 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


Secondary Outcome Measures :
  1. Anxiety symptoms [ Time Frame: Rehabilitation discharge (generally 4-6 weeks), 3 weeks post-discharge ]
    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

  2. Stress [ Time Frame: Rehabilitation discharge (generally 4-6 weeks), 3 weeks post-discharge ]
    10-item Perceived Stress Scale; total scores range from 0 to 40; higher values indicate higher perceived stress

  3. Motivation [ Time Frame: Rehabilitation discharge (generally 4-6 weeks), 3 weeks post-discharge ]
    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

  4. Happiness [ Time Frame: Rehabilitation discharge (generally 4-6 weeks), 3 weeks post-discharge ]
    4-item Subjective Happiness Scale; Mean scores range from 1 to 7; higher values indicate higher happiness

  5. Stroke severity (functional disability) [ Time Frame: Rehabilitation discharge (generally 4-6 weeks), 3 weeks post-discharge ]
    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

  6. Sedentary time [ Time Frame: Rehabilitation discharge (generally 4-6 weeks), 3 weeks post-discharge ]
    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


Other Outcome Measures:
  1. Feasibility indicator - recruitment rate [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    Number of participants recruited per week

  2. Feasibility indicator - retention rate [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    Number of participants that complete the study, relative to the number that started the study

  3. Feasibility indicator - perceived benefit of the VR Training Program, [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    17-item study specific Satisfaction survey; Mean scores range from 1 to 5; Higher scores indicate greater satisfaction

  4. Feasibility indicators - treatment fidelity [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    Percentage of participants that participate in ALL VR Training sessions

  5. Feasibility indicators - participant and tester burden [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    Percentage of participants that complete a data collection session in 60 minutes or less

  6. Feasibility indicators - trainer burden [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    Time spent administering each VR session

  7. Feasibility indicators - ease of using equipment [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    Downtime due to technical difficulties

  8. Feasibility indicators - safety [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    Number of adverse events due to the VR Training program



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011202


Locations
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Canada, British Columbia
Kelowna General Hospital
Kelowna, British Columbia, Canada, V1Y 1T2
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Brodie Sakakibara University of British Columbia
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Responsible Party: Brodie Sakakibara, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04011202    
Other Study ID Numbers: VR Stroke
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brodie Sakakibara, University of British Columbia:
Stroke
Virtual reality
Depressive symptoms
Sedentary behaviour
Additional relevant MeSH terms:
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Stroke
Stroke, Lacunar
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebral Small Vessel Diseases