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Virtual Reality, Mood, and Sedentary Behaviour After Stroke

Primary Purpose

Stroke, Stroke, Ischemic, Stroke Hemorrhagic

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual reality gaming program (VR-gaming program)
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Virtual reality, Depressive symptoms, Sedentary behaviour

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kelowna General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

VR Group

Control Group

Arm Description

Receives the VR protocol

Receives regular care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Stress
10-item Perceived Stress Scale; total scores range from 0 to 40; higher values indicate higher perceived stress
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
Happiness
4-item Subjective Happiness Scale; Mean scores range from 1 to 7; higher values indicate higher happiness
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
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

Full Information

First Posted
July 3, 2019
Last Updated
December 1, 2022
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04011202
Brief Title
Virtual Reality, Mood, and Sedentary Behaviour After Stroke
Official Title
Virtual Reality, Mood, and Sedentary Behaviour After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID-19; lack of recruitment; staff turnover.
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Stroke, Lacunar
Keywords
Stroke, Virtual reality, Depressive symptoms, Sedentary behaviour

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control group and experimental group
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR Group
Arm Type
Experimental
Arm Description
Receives the VR protocol
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Receives regular care
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality gaming program (VR-gaming program)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depressive symptoms
Description
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)
Secondary Outcome Measure Information:
Title
Anxiety symptoms
Description
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)
Title
Stress
Description
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)
Title
Motivation
Description
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)
Title
Happiness
Description
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)
Title
Stroke severity (functional disability)
Description
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)
Title
Sedentary time
Description
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)
Other Pre-specified Outcome Measures:
Title
Feasibility indicator - recruitment rate
Description
Number of participants recruited per week
Time Frame
Rehabilitation discharge (generally 4-6 weeks)
Title
Feasibility indicator - retention rate
Description
Number of participants that complete the study, relative to the number that started the study
Time Frame
Rehabilitation discharge (generally 4-6 weeks)
Title
Feasibility indicator - perceived benefit of the VR Training Program,
Description
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)
Title
Feasibility indicators - treatment fidelity
Description
Percentage of participants that participate in ALL VR Training sessions
Time Frame
Rehabilitation discharge (generally 4-6 weeks)
Title
Feasibility indicators - participant and tester burden
Description
Percentage of participants that complete a data collection session in 60 minutes or less
Time Frame
Rehabilitation discharge (generally 4-6 weeks)
Title
Feasibility indicators - trainer burden
Description
Time spent administering each VR session
Time Frame
Rehabilitation discharge (generally 4-6 weeks)
Title
Feasibility indicators - ease of using equipment
Description
Downtime due to technical difficulties
Time Frame
Rehabilitation discharge (generally 4-6 weeks)
Title
Feasibility indicators - safety
Description
Number of adverse events due to the VR Training program
Time Frame
Rehabilitation discharge (generally 4-6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brodie Sakakibara
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kelowna General Hospital
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1T2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
36273223
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.
Results Reference
derived

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Virtual Reality, Mood, and Sedentary Behaviour After Stroke

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