CClinicalTrials.gg
Not yet recruitingNCT07032155Updated Jun 22, 2025

Virtual Reality in Occupational Therapy Upper Limb Stroke Rehabilitation

An interventional study of Resynk VR session and Using Resynk VR on stroke survivors in Stroke, sponsored by eXRt Intelligent Healthcare. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-06-22.

Sponsored by eXRt Intelligent Healthcare · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

This is the only study on the registry with eXRt Intelligent Healthcare as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    stroke survivor participant group

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

    Device: Resynk VR session

  • Other
    Occupational therapist Participant group

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

    Other: Using Resynk VR on stroke survivors

Interventions

  • DeviceResynk 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.

  • OtherUsing 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

06

What researchers measure

Primary outcomes

  1. System Usability Scale

    Scale assess the usability of the resynk VR system for both arms higher score mean higher usability

    Time frame: Day 1 & Day 30

  2. Safety and Acceptability Questionnaire

    A custom Questionnaire to evaluate the safety and acceptability of Resynk VR in both arms

    Time frame: Day 1 & Day 30

Secondary outcomes

  1. Upper limb function (Fugl-Meyer Assessment)

    The standardised Fugl meyer upper limb assessment to assess upper limb function stroke survivor arm only

    Time frame: Day 1 & Day 30

  2. Quality of life (EQ-5D-5L)

    Assess the quality of life of the patient before and after intervention stroke survivor arm only

    Time frame: Day 1 & Day 30 & Day 60

  3. self-efficacy (General Self-Efficacy Scale)

    self-efficacy is a person's perception of their ability to perform tasks stroke survivor arm only

    Time frame: Day 1 & Day 30

  4. 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

    Time frame: Day 1 & Day 30

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07032155
Lead sponsor
eXRt Intelligent Healthcare
Collaborators
Belfast Health and Social Care Trust
Responsible party
Sponsor
First posted
Jun 22, 2025
Start date
Jul 1, 2025 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jun 22, 2025

Study contacts

Dominic Holmes, PhD
Contact
dominic@exrt.io
07514575765
Emma Dunn, Bsc
principal investigator · Belfast Health and Social Care Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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