The VIRTUE study: Can virtual reality games help people with cognitive impairment following a stroke to regain the ability to perform daily activities?

INTERVENTION: Stage 1: Screening: Adult patients (over the age of 18 years) admitted with a stroke (ischaemic or haemorrhagic: diagnosis confirmed by a stroke physician) will be screened consecutively using the pre‐specified inclusion/exclusion criteria. Recruitment is required within 3 weeks of index stroke. Screening log: Recruitment and reasons for exclusion or declining (if offered by the patient) will be documented using a detailed screening log. Stage 2: Recruitment: After reviewing the inclusion and exclusion criteria, all eligible patients will be invited by a GCP‐trained healthcare professional to take part in this trial. They/their next of kin will receive the written study information and will be allowed to ask questions before obtaining written consent. The consent will be obtained by a GCP‐trained experienced stroke research nurse either from the potential participants or from participants’ next of kin if the patient lacks capacity. Also, if the patient is unable to write due to his/her weakness, independent witness consent will be obtained. We will recruit up to 60 patients exhibiting post‐stroke cognitive impairment (PSCI) established by a score of less than 26 out of 30 on the Montreal Cognitive Assessment (MoCA) over a 1‐year period. The baseline assessment will be obtained by a trained research nurse/therapy assistant before the randomisation procedure. Stage 3: Baseline assessment, which will be obtained by face‐to‐face interview Stage 4: Randomisation: Following the completion of the baseline assessment, patients will be randomised and will be stratified based on baseline MoCA score in two groups (<15 and 15‐25) on a 3:1 allocation basis to receive either VR plus usual care or sham VR plus usual care. Stage 5: Intervention: Treatment group 1 (VIRTUE therapy plus usual care): 40 patients with PSCI in the VR group will receive dai CONDITION: Cognitive impairment following a stroke ; Nervous System Diseases PRIMARY OUTCOME: ; Current primary outcome measures as of 04/10/2019:; 1. Acceptability of the trial to patients measured using a questionnaire within 1 week following the end of the intervention; 2. Cognitive function assessed using Cognitive Assessment of Minnesota (CAM) at baseline, the end of the intervention and 3 months after the end of the intervention; ; Previous primary outcome measures:; 1. Feasibility and acceptability of VR‐based cognitive rehabilitation in patients with cognitive impairment immediately after a stroke; 2. Identification of the optimum dosing of VR‐based cognitive rehabilitation; ; INCLUSION CRITERIA: 1. Aged over 18 years 2. Have suffered a unilateral stroke (both ischaemic and haemorrhagic as diagnosed by stroke physician) between 1 day to 3 weeks previously 3. No or minor pre‐stroke handicap defined by modified Rankin scale score before stroke between 0 and 2 4. MoCA score <26 (out of 30) AND a trained Occupational Therapist has identified that the patient who will benefit from further cognitive therapy SECONDARY OUTCOME: ; Current secondary outcome measures as of 04/10/2019:; 1. Acceptability of the trial to staff measured using a questionnaire following the end of the recruitment in the trial; 2. Ability to perform activities of daily living (ADL) assessed using the Nottingham Extended ADL Scale at baseline and 3 months after the end of the intervention; 3. Mood assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline and 3 months after the end of the intervention; 4. Quality of life assessed using EuroQol at baseline and 3 months after the end of the intervention; 5. Arm function using Action Research Arm Test (ARAT) at baseline and 3 months after the end of the intervention; ; Previous secondary outcome measures:; 1. Assess the feasibility of using sham VR as a control in the future phase III RCT; 2. Acceptability of VR‐based cognitive rehabilitation amongst the staff;