StrokeNCT07032155
Virtual Reality in Occupational Therapy Upper Limb Stroke Rehabilitation
A study testing Resynk VR session and Using Resynk VR on stroke survivors in people with Stroke, run by eXRt Intelligent Healthcare at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke
- What is being tested?
- Resynk VR session and Using Resynk VR on stroke survivors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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.
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Royal Victoria Hospital
Belfast, Down, BT12 6BA
Emma Dunn, BSc, Emma.Dunn@belfasttrust.hscni.net
Niamh Keaveny, BSc, Niamh.Keaveny@belfasttrust.hscni.net
About this study
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
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
- Being tested
- Resynk VR session, Using Resynk VR on stroke survivors
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resynk VR sessionDevice
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.
Using Resynk VR on stroke survivorsOther
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
| Study group | Role | What they receive |
|---|---|---|
| stroke survivor participant group | Active comparator | Participants receive VR therapy 30mins of the intervention 3 times a week for 4 weeks Receives: Device: Resynk VR session |
| Occupational therapist Participant group | Other | Occupational therapist Participants receive training and use VR on stroke survivor participants Receives: Other: Using Resynk VR on stroke survivors |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale
Scale assess the usability of the resynk VR system for both arms higher score mean higher usability
Measured: Day 1 & Day 30
Safety and Acceptability Questionnaire
A custom Questionnaire to evaluate the safety and acceptability of Resynk VR in both arms
Measured: Day 1 & Day 30
Secondary outcomes (4)
Upper limb function (Fugl-Meyer Assessment)
The standardised Fugl meyer upper limb assessment to assess upper limb function stroke survivor arm only
Measured: Day 1 & Day 30
Quality of life (EQ-5D-5L)
Assess the quality of life of the patient before and after intervention stroke survivor arm only
Measured: Day 1 & Day 30 & Day 60
self-efficacy (General Self-Efficacy Scale)
self-efficacy is a person's perception of their ability to perform tasks stroke survivor arm only
Measured: Day 1 & Day 30
rehabilitation intensity (resynk repetition count vs average conventional therapy based on literature)
Compare resynk rehab intensity vs conventional to show service improvement or not, stroke survivor arm only
Measured: Day 1 & Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- eXRt Intelligent Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Belfast Health and Social Care Trust
- Responsible party
- Sponsor
- Investigators
- Emma Dunn, Bsc, Principal investigator, Belfast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032155
- Sponsor's protocol ID
- EIHCT001
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07032155
- Acronym / sponsor ID
- EIHCT001
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- eXRt Intelligent HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Belfast Health and Social Care Trust
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stroke survivor participant group | Active comparator | Device: Resynk VR sessionParticipants receive VR therapy 30mins of the intervention 3 times a week for 4 weeks |
| Occupational therapist Participant group | Other | Other: Using Resynk VR on stroke survivorsOccupational therapist Participants receive training and use VR on stroke survivor participants |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resynk VR sessionThe 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. | Device | stroke survivor participant group |
| Using Resynk VR on stroke survivorsThe 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 | Other | Occupational therapist Participant group |
Primary outcome
System Usability Scale
Time frame: Day 1 & Day 30
Scale assess the usability of the resynk VR system for both arms higher score mean higher usability
Safety and Acceptability Questionnaire
Time frame: Day 1 & Day 30
A custom Questionnaire to evaluate the safety and acceptability of Resynk VR in both arms
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
RecruitingObservational study
Natural History of Stroke: Cause and Development
Brain Disease, Ischemic Attack, Transient
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
Active, not recruitingPhase 3
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Intracranial Arteriosclerosis, Stroke
Recruiting
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
Stroke, Implantation of an Implantable Cardiac Monitor
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emma Dunn, Bsc principal investigator
Belfast Health and Social Care Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resynk VR session and Using Resynk VR on stroke survivors in people with Stroke, run by eXRt Intelligent Healthcare at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominic Holmes, PhD (07514575765, dominic@exrt.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: Day 1 & Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025; AzTrials last refreshed its copy on 26 Oct 2026.