Virtual Reality in Occupational Therapy Upper Limb Stroke Rehabilitation

Official title

The Feasibility of Implementing Virtual Reality-based Upper Limb Rehabilitation for Stroke Patients and Occupational Therapists in an Acute Stroke Unit and Community Stroke Team, in Terms of Technology Acceptance, Safety and Usability

Overview

The study aims to assess the feasibility of using Resynk, a virtual reality (VR) software platform for upper limb rehabilitation for stroke survivors, both in acute hospital settings and in the community (home, private nursing home, residential home). Resynk offers interactive, task-oriented training that enhances therapy intensity and patient motivation. Previous findings from a Quality Improvement project showed significant increases in treatment intensity and patient engagement with Resynk. This study will explore barriers to Resynk implementation and gather input from staff participants and stroke survivors to ensure successful integration and effectiveness. Resynk will be delivered alongside standard care, with no intention to delay or reduce existing rehabilitation services. The study involves two participant groups -adult stroke survivors and Occupational Therapists. These represent realistic and appropriate user groups for this stage of implementation research. A control group is not included, as the primary aim is not comparative effectiveness but to assess feasibility and user experience. This study will use a exploratory approach to using qualitative methods for gather insight into safety, acceptability and usability such as the System usability Scale, EQ-5D-5L and custom design Questionnaire. Quantitative methods will be used for evaluating rehabilitating and function outcomes this includes data collected by the Resynk application and the standardised Fugl Meyers assessment. The study will involve pre, post and follow up data collection for both participant groups.

Interventions

• Device Resynk VR session
  The study will use hardware and software to achieve this immersive virtual reality. The Resynk Virtual Reality programme (software) and the Meta Quest Virtual Reality Headset (hardware) will be used. Immersive virtual reality (VR) is when technology makes you feel like you're inside a different world. You wear a virtual reality headset that covers your eyes and ears, showing you a 3D world and playing matching sounds. The headset's head tracking, changing the view in the VR world as you look aro
• Other Using Resynk VR on stroke survivors
  The Resynk Virtual Reality programme (software) and the Meta Quest Virtual Reality Headset (hardware) will be used by Occupational therapy participants to treat the stroke survivor participants

Primary outcome measures

• System Usability Scale [Time frame: Day 1 & Day 30]
• Safety and Acceptability Questionnaire [Time frame: Day 1 & Day 30]

Secondary outcome measures (4)

• Upper limb function (Fugl-Meyer Assessment) [Time frame: Day 1 & Day 30]
• Quality of life (EQ-5D-5L) [Time frame: Day 1 & Day 30 & Day 60]
• self-efficacy (General Self-Efficacy Scale) [Time frame: Day 1 & Day 30]
• rehabilitation intensity (resynk repetition count vs average conventional therapy based on literature) [Time frame: Day 1 & Day 30]

Eligibility criteria

Inclusion criteria

Stroke Participants

Able to provide informed consent

Aged over 18 years.

Evidence of stroke confirmed by medical team

Newly diagnosed patients who are admitted to the acute stroke unit with a confirmed diagnosis of stroke.

More than 48 hours since stroke event

Patient is appropriate to participate in rehabilitation according to the treating physician or medical consultant, and able to follow simple verbal commands.

Presence of an upper limb deficit identified in the NIHSS (National Institutes of Health Stroke Scale) or by a member of the medical or multidisciplinary team

Residents within the Belfast health and social care trust catchment area/postcode

Staff participants:

Qualified Registered Occupational Therapy Staff who work in the Stroke Unit in the Royal Victoria Hospital Belfast or in the Community Stroke Team in the Belfast Health and Social Care Trust.

Able to provide informed consent

Aged 18 or over

Exclusion criteria

Stroke Participants:

Stroke onset more than 3 months prior to study entry.

Acutely medically unwell as per medical team

Patient is unable to follow verbal commands or has global aphasia. Interpreters may be used to accommodate stroke survivors' communication needs.

Severe illness with a life expectancy of less than 3 months (e.g., cancer, endocarditis, metastasis with an occult primary malignancy).

Uncontrolled hypertension as assessed by the treating physician.

Unstable angina or recent myocardial infarction.

Any history of epilepsy or seizures, except for febrile seizures of childhood.

Current participation in another clinical trial involving rehabilitation (e.g., recreational therapy, occupational therapy, physiotherapy) or an investigational drug that might interfere with study results.

Patient is unwilling or unable to comply with the protocol or cannot/will not cooperate fully with the investigator or study personnel.

Any physical health condition, mental health condition, or other medical condition or diagnosis that might confound the interpretation of results or put the patient at risk (e.g., amputation of one extremity).

History of vertigo.

Active delirium/significant levels of confusion

Cervical artery dissection.

Patients with implanted devices such as pacemakers, defibrillators, and cochlear implants.

Individual currently being managed under the Mental Capacity Act

Staff participants:

Uncontrolled hypertension as assessed by the treating physician.

Unstable angina or recent myocardial infarction

Any history of epilepsy, seizures, except for febrile seizures of childhood.

Current participation in another clinical trial involving rehabilitation (e.g., recreational therapy, occupational therapy, physiotherapy) or an investigational drug that might interfere with study results.

Any physical health condition, mental health condition, or other medical condition or diagnosis that might confound the interpretation of results or put the patient at risk (e.g., amputation of one extremity).

History of vertigo.

Cervical artery dissection.

Staff members with implanted devices such as pacemakers, defibrillators, and cochlear implants.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Basic science

Study locations

United Kingdom · 1 center

• Royal Victoria Hospital — Belfast

Identifiers

NCT: NCT07032155 · EIHCT001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗