Virtual Reality in Occupational Therapy Upper Limb Stroke Rehabilitation

NCT ID: NCT07032155

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

stroke survivor participant group

Participants receive VR therapy 30mins of the intervention 3 times a week for 4 weeks

Group Type: ACTIVE_COMPARATOR

Resynk VR session

Intervention Type: DEVICE

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 around. You can then interact with this virtual reality world depending on the application or game you use. The Resynk VR software launches automatically, guiding them through therapist-designed games that make rehabilitation engaging. The system uses advanced hand-tracking technology, eliminating the need for physical controllers. It detects joint movements in the hands and fingers, allowing users to perform key rehabilitation exercises such as supination, pronation, grasping, and pinching.

Occupational therapist Participant group

Occupational therapist Participants receive training and use VR on stroke survivor participants

Group Type: OTHER

Using Resynk VR on stroke survivors

Intervention Type: OTHER

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

Interventions

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 around. You can then interact with this virtual reality world depending on the application or game you use. The Resynk VR software launches automatically, guiding them through therapist-designed games that make rehabilitation engaging. The system uses advanced hand-tracking technology, eliminating the need for physical controllers. It detects joint movements in the hands and fingers, allowing users to perform key rehabilitation exercises such as supination, pronation, grasping, and pinching.

Intervention Type: DEVICE

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Belfast Health and Social Care Trust

OTHER

Sponsor Role: collaborator

eXRt Intelligent Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emma Dunn, Bsc

Role: PRINCIPAL_INVESTIGATOR

Belfast Health and Social Care Trust

Locations

Royal Victoria Hospital

Belfast, Down, United Kingdom

Countries

United Kingdom

Central Contacts

Dominic Holmes, PhD

Role: CONTACT

dominic@exrt.io

07514575765

Facility Contacts

Emma Dunn, BSc

Role: primary

Emma.Dunn@belfasttrust.hscni.net

Niamh Keaveny, BSc

Role: backup

Niamh.Keaveny@belfasttrust.hscni.net

Other Identifiers

EIHCT001

Identifier Type: -

Identifier Source: org_study_id