Stroke Clinical Trial
Official title:
Virtual Reality, Mood, and Sedentary Behaviour After Stroke
Verified date | December 2022 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 28 |
Est. completion date | April 30, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Kelowna General Hospital | Kelowna | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Feasibility indicator - recruitment rate | Number of participants recruited per week | Rehabilitation discharge (generally 4-6 weeks) | |
Other | Feasibility indicator - retention rate | Number of participants that complete the study, relative to the number that started the study | Rehabilitation discharge (generally 4-6 weeks) | |
Other | Feasibility indicator - perceived benefit of the VR Training Program, | 17-item study specific Satisfaction survey; Mean scores range from 1 to 5; Higher scores indicate greater satisfaction | Rehabilitation discharge (generally 4-6 weeks) | |
Other | Feasibility indicators - treatment fidelity | Percentage of participants that participate in ALL VR Training sessions | Rehabilitation discharge (generally 4-6 weeks) | |
Other | Feasibility indicators - participant and tester burden | Percentage of participants that complete a data collection session in 60 minutes or less | Rehabilitation discharge (generally 4-6 weeks) | |
Other | Feasibility indicators - trainer burden | Time spent administering each VR session | Rehabilitation discharge (generally 4-6 weeks) | |
Other | Feasibility indicators - ease of using equipment | Downtime due to technical difficulties | Rehabilitation discharge (generally 4-6 weeks) | |
Other | Feasibility indicators - safety | Number of adverse events due to the VR Training program | Rehabilitation discharge (generally 4-6 weeks) | |
Primary | 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 | Rehabilitation discharge (generally 4-6 weeks) | |
Secondary | 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 | Rehabilitation discharge (generally 4-6 weeks) | |
Secondary | Stress | 10-item Perceived Stress Scale; total scores range from 0 to 40; higher values indicate higher perceived stress | Rehabilitation discharge (generally 4-6 weeks) | |
Secondary | 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 | Rehabilitation discharge (generally 4-6 weeks) | |
Secondary | Happiness | 4-item Subjective Happiness Scale; Mean scores range from 1 to 7; higher values indicate higher happiness | Rehabilitation discharge (generally 4-6 weeks) | |
Secondary | 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 | Rehabilitation discharge (generally 4-6 weeks) | |
Secondary | 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 | Rehabilitation discharge (generally 4-6 weeks) |
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