4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Virtual Reality, Mood, and Sedentary Behaviour After Stroke

Virtual Reality, Mood, and Sedentary Behaviour After Stroke

Study Description
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.

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. 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


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


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Brodie Sakakibara, PhD 250 807 8505 brodie.sakakibara@ubc.ca

Locations
Layout table for location information
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         
Sponsors and Collaborators
University of British Columbia
Investigators
Layout table for investigator information
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
 (submitted: May 19, 2021)
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
 (submitted: July 5, 2019)
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
 (submitted: May 19, 2021)
  • Anxiety symptoms [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    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
  • Stress [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    10-item Perceived Stress Scale; total scores range from 0 to 40; higher values indicate higher perceived stress
  • Motivation [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    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
  • Happiness [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    4-item Subjective Happiness Scale; Mean scores range from 1 to 7; higher values indicate higher happiness
  • Stroke severity (functional disability) [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    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
  • Sedentary time [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
  • Anxiety symptoms [ Time Frame: Baseline, 3-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
  • Stress [ Time Frame: Baseline, 3-weeks, 3 weeks post-discharge ]
    10-item Perceived Stress Scale; total scores range from 0 to 40; higher values indicate higher perceived stress
  • Motivation [ Time Frame: Baseline, 3-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
  • Happiness [ Time Frame: Baseline, 3-weeks, 3 weeks post-discharge ]
    4-item Subjective Happiness Scale; Mean scores range from 1 to 7; higher values indicate higher happiness
  • Stroke severity (functional disability) [ Time Frame: Baseline, 3-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
  • Sedentary time [ Time Frame: Baseline, 3-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
Current Other Pre-specified Outcome Measures
 (submitted: March 12, 2020)
  • Feasibility indicator - recruitment rate [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    Number of participants recruited per week
  • 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
  • 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
  • Feasibility indicators - treatment fidelity [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    Percentage of participants that participate in ALL VR Training sessions
  • 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
  • Feasibility indicators - trainer burden [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    Time spent administering each VR session
  • Feasibility indicators - ease of using equipment [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    Downtime due to technical difficulties
  • Feasibility indicators - safety [ Time Frame: Rehabilitation discharge (generally 4-6 weeks) ]
    Number of adverse events due to the VR Training program
Original Other Pre-specified Outcome Measures
 (submitted: July 5, 2019)
  • Feasibility indicator - recruitment rate [ Time Frame: After end of intervention (i.e., 3-weeks) ]
    Number of participants recruited per week
  • Feasibility indicator - retention rate [ Time Frame: After end of intervention (i.e., 3-weeks) ]
    Number of participants that complete the study, relative to the number that started the study
  • Feasibility indicator - perceived benefit of the VR Training Program, [ Time Frame: After end of intervention (i.e., 3-weeks) ]
    17-item study specific Satisfaction survey; Mean scores range from 1 to 5; Higher scores indicate greater satisfaction
  • Feasibility indicators - treatment fidelity [ Time Frame: After end of intervention (i.e., 3-weeks) ]
    Percentage of participants that participate in ALL VR Training sessions
  • Feasibility indicators - participant and tester burden [ Time Frame: After end of intervention (i.e., 3-weeks) ]
    Percentage of participants that complete a data collection session in 60 minutes or less
  • Feasibility indicators - trainer burden [ Time Frame: After end of intervention (i.e., 3-weeks) ]
    Time spent administering each VR session
  • Feasibility indicators - ease of using equipment [ Time Frame: After end of intervention (i.e., 3-weeks) ]
    Downtime due to technical difficulties
  • Feasibility indicators - safety [ Time Frame: After end of intervention (i.e., 3-weeks) ]
    Number of adverse events due to the VR Training program
 
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
  • Stroke
  • Stroke, Ischemic
  • Stroke Hemorrhagic
  • Stroke, Lacunar
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
  • Experimental: VR Group
    Receives the VR protocol
    Intervention: Behavioral: Virtual reality gaming program (VR-gaming program)
  • No Intervention: Control Group
    Receives regular care
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
 (submitted: May 19, 2021)
30
Original Estimated Enrollment  ICMJE
 (submitted: July 5, 2019)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Brodie Sakakibara, PhD 250 807 8505 brodie.sakakibara@ubc.ca
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Principal Investigator: Brodie Sakakibara University of British Columbia
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