Magic Glass Evaluation in People With Stroke

Ulster University

Status

Unknown

Conditions

Stroke

Treatments

Device: Magic Glass

Study type

Interventional

Funder types

Other

Identifiers

NCT04307108

18/NI/0080

Details and patient eligibility

About

Background: Virtual Reality (VR) technology may help to provide a way for stroke survivors to exercise in their own time at home, with remote clinical support. Before we introduce this technology we need to test that it will work alongside current health services for stroke survivors. Aims: To find out if using the MAGIC-GLASS solution alongside current healthcare care is usable and acceptable to stroke survivors and helps to increase rehabilitation time. Design: Measures before and after stroke survivors use the MAGIC-GLASS solution.

Setting: Stroke survivors will use the MAGIC-GLASS solution in their own home. Population: adults (≥18 years) who have had a stroke at least two weeks before they enter into the study.

Interventions: Our VR technology is called MAGIC-GLASS, and in order to use the solution the user puts on a headset which is connected to a computer. They can then see a VR environment in which they will be able to see virtual hands that respond to the movements of their own hands. It will also be possible to see a mirror image of their hands moving. The system will record how much they use the system and improvement in their movement. Regular contact will be made with a clinician who will be able to use the system to see (from their clinic) how the stroke survivor is doing and talk to them. Outcomes: We want to find out how the stroke survivors' movement changes over time and what they think of using the system. We will also ask clinical staff what they thought of using the system as part of healthcare provision to stroke survivors. Finally we want to find out how much it will cost to use the system.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Any time point post stroke
Medically stable (and without uncontrolled seizures or vertigo)
No or mild cognitive deficit: can follow two step commands
No significant visual or spatial neglect (Can turn head towards an image when asked to do so and keep attention). People with hemianopia or other visual deficits can be included dependent on clinical opinion
Normal or normal corrected vision
Be able to get in and out from a seat with assistance; can be used in a wheelchair as long as arms can rest on table
Have a carer to assist putting on the headset
Be willing to give consent
For those not using mirror therapy, can move impaired arm without significant pain

Exclusion criteria

• People with a moderate to severe cognitive impairment (MoCA<20).
- Those with a visual impairment who are unable to see a clear image with the headset.
- Patients with severe neuropsychological deficits such as severe neglect or apraxia as indicated by their clinical team.
- Patients who are medically unwell e.g. with history of solid organ or bone marrow transplantation, active malignancy within 24 months prior to screening or metastatic cancer, life expectancy less than 6 months, Congestive heart failure in New York Heart Association (NYHA) Functional Classification IV (severe) stage.
- Those with complete dependency in Activities of Daily Living, any medical or other reason (e.g. known or suspected inability of the participant to comply with the protocol procedure) that investigator opinion that the participant is unsuitable for the study.
- Patients unwilling to provide consent and those who cannot be followed-up at any time point will be excluded from the study.
- Epilepsy, seizures and history of vertigo (possible exclusion determined by clinician).
- Those with upper limb sensory disturbance who are unwilling to keep their nails short for the duration of the study.