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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.
Enrollment
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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.
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups
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Central trial contact
Dominic Holmes, PhD
Data sourced from clinicaltrials.gov
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