VIRTUE
Research type
Research Study
Full title
VIRTUE: VIRTUal reality based cognitive rehabilitation immediately after a strokE: a double-blind phase 2b pilot randomised controlled trial to identify the optimum dosing, acceptability of VR based treatment and test the feasibility.
IRAS ID
265538
Contact name
Kausik Chatterjee
Contact email
Sponsor organisation
Countess of Chester NHS Foundation Trust
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Research Summary
Strokes commonly affect the way we understand, organise and store information as well as interact with our environment- often referred to as ‘cognitive impairment’. These 'cognitive impairments' after a stroke might affect the patient’s ability to concentrate, remember information, plan or solve problems they routinely face during their day-to-day activities, notice or recognise things, or navigate their home and surroundings. Fortunately, some of this cognitive impairment improves with intensive guided practice, and there is some evidence that suggests that therapy using virtual reality based computer programs can speed up this improvement.
We are funded by the 'Innovate UK' to develop a virtual reality based post-stroke cognitive rehabilitation program called 'VIRTUE'. The program contains different tasks and scenarios resembling normal activities of daily living that the patient would perform during their regular therapy sessions. Each task will be graded with different levels of complexity to suit the patient’s abilities and rate of recovery. The plan is to deliver additional therapy sessions to the participants by a semi-trained therapist along with their regular therapy sessions.
VIRTUE trial designed is to test the feasibility, optimum dosing and acceptability of VIRTUE. We are planning to recruit 60 eligible participants in the first three weeks after stroke. The trail has two arms. In the active treatment arm, participants will receive VIRTUE sessions at a different dose and duration, along with their regular therapy sessions. Also, in the control arm participants will receive a sham virtual reality based treatment for two weeks along with their usual therapy sessions. Participants from both these groups will be tested their cognitive function before the start of their treatment, after completion of VIRTUE/sham VIRTUE treatment and also at three months. Any adverse event from the treatment will be monitored continuously during these three months.Summary of Results
We have developed a novel immersive Virtual Reality system aimed at the cognitive rehabilitation of stroke survivors. The system has been deployed in a hospital setting and used to enhance the therapy of 40 patients recovering from a stroke. Although patient supervision was required for this trial, it was under-taken by a Therapy Assistant, freeing up time for the Occupational Therapist. Data was collected from a 12-month trial conducted over an18 month time period (which included a six-month suspension during 2020 due to the constraints of the covid-19 pandemic). Most stroke patients encountered had not previously been exposed to Virtual Reality, but this did not deter their enthusiasm to embrace the latest Virtual Reality technology and to begin to use it to their advantage. VIRTUE is intended to benefit the health service and results from the trial indicate that it is safe, may accelerate patient recovery through intensive delivery of therapy with minimal supervision, and may shorten hospital stays and lower healthcare costs. For clinicians, it is expected to free up time for patients with more complex needs. For patients, recovery will be more effective because the therapy is more engaging, delivered more often and could potentially continue at home. Our approach has started to transform the delivery of cognitive stroke rehabilitation through a new digital Virtual Reality service. A phase 3 trial involving more than one stroke centre to assess its efficacy is needed to implement this form of treatment in day to day care.
REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0419
Date of REC Opinion
11 Sep 2019
REC opinion
Further Information Favourable Opinion