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

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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16608742

Enrollment

Registered

2019-10-03

Start date

2019-10-03

Completion date

Unknown

Last updated

2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive impairment following a stroke Nervous System Diseases

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. History of dementia before the stroke 2. Unfit/too ill to receive occupational therapy within 3 weeks 3. Visual acuity <6/60 4. History of epilepsy 5. Bilateral arm weakness or cannot use their unaffected arm 6. Not able/willing to provide informed consent

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026