NCT04011202

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 21, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

December 5, 2022

Status Verified

December 1, 2022

Enrollment Period

2.7 years

First QC Date

July 3, 2019

Last Update Submit

December 1, 2022

Conditions

StrokeStroke, IschemicStroke HemorrhagicStroke, Lacunar

Keywords

StrokeVirtual realityDepressive symptomsSedentary behaviour

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Anxiety symptoms

    Rehabilitation discharge (generally 4-6 weeks)

  • Stress

    Rehabilitation discharge (generally 4-6 weeks)

  • Motivation

    Rehabilitation discharge (generally 4-6 weeks)

  • Happiness

    Rehabilitation discharge (generally 4-6 weeks)

  • Stroke severity (functional disability)

    Rehabilitation discharge (generally 4-6 weeks)

  • +1 more secondary outcomes

Other Outcomes (8)

  • Feasibility indicator - recruitment rate

    Rehabilitation discharge (generally 4-6 weeks)

  • Feasibility indicator - retention rate

    Rehabilitation discharge (generally 4-6 weeks)

  • Feasibility indicator - perceived benefit of the VR Training Program,

    Rehabilitation discharge (generally 4-6 weeks)

  • +5 more other outcomes

Study Arms (2)

VR Group

EXPERIMENTAL

Receives the VR protocol

Behavioral: Virtual reality gaming program (VR-gaming program)

Control Group

NO INTERVENTION

Receives regular care

Interventions

Virtual reality gaming program (VR-gaming program)BEHAVIORAL

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.

VR Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kelowna General Hospital

Kelowna, British Columbia, V1Y 1T2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 36273223DERIVED

MeSH Terms

Conditions

StrokeIschemic StrokeHemorrhagic StrokeStroke, LacunarDepression

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCerebral Small Vessel DiseasesThrombotic StrokeBrain InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisBehavioral SymptomsBehavior

Study Officials

  • Brodie Sakakibara

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Control group and experimental group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 8, 2019

Study Start

August 21, 2019

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

December 5, 2022

Record last verified: 2022-12

Locations

CA(1)