Virtual Reality in Occupational Therapy Upper Limb Stroke Rehabilitation

NCT07032155 | Not Yet Recruiting

• 1 other identifier: EIHCT001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• System Usability Scale

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

  Day 1 & Day 30

• Safety and Acceptability Questionnaire

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

  Day 1 & Day 30

Secondary Outcomes (4)

• Upper limb function (Fugl-Meyer Assessment)

  Day 1 & Day 30

• Quality of life (EQ-5D-5L)

  Day 1 & Day 30 & Day 60

• self-efficacy (General Self-Efficacy Scale)

  Day 1 & Day 30

• rehabilitation intensity (resynk repetition count vs average conventional therapy based on literature)

  Day 1 & Day 30

Study Arms (2)

stroke survivor participant group

ACTIVE COMPARATOR

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

Device: Resynk VR session

Occupational therapist Participant group

OTHER

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

Other: Using Resynk VR on stroke survivors

Interventions

Resynk VR session 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.

stroke survivor participant group

Using Resynk VR on stroke survivors 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

Occupational therapist Participant group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• eXRt Intelligent Healthcare: lead
• Belfast Health and Social Care Trust: collaborator

Study Sites (1)

Royal Victoria Hospital

Belfast, Down, BT12 6BA, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Emma Dunn, Bsc

  Belfast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominic Holmes, PhD

CONTACT

07514575765; dominic@exrt.io

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 22, 2025
• Study Start: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)