Clinical trial NCT04307108: Magic Glass Evaluation in People With Stroke
Official title: Evaluation of the Acceptability and Usability of the MAGIC-GLASS Solution as Part of the Care Pathway in People With Acute, Sub-Acute and Chronic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke, virtual reality, upper limb
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Western Health and Social Care Trust
name: Southern Health and Social Care Trust
name: Tech 4 Care
name: miThings AB
First posted: 2020-03-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: the usability of the intervention;
timeFrame: through study completion, an average of 6 months
measure: the usability of the intervention
timeFrame: through study completion, an average of 6 months
measure: the acceptability of the intervention
timeFrame: through study completion, an average of 6 months
measure: the process requirements for the new care pathway;
timeFrame: through study completion, an average of 6 months
measure: the resource requirements for the new care pathway;
timeFrame: through study completion, an average of 6 months
measure: the intensity in Rehabilitation Therapy
timeFrame: Change from baseline to end of intervention (6 months)
measure: the duration in Rehabilitation Therapy
timeFrame: Change from baseline to end of intervention (6 months)
Secondary outcomes:
measure: Functional independence in the activities of daily living with respect to the modified Rankin Scale
timeFrame: Change from baseline to end of intervention (6 months)
measure: Functional independence in the activities of daily living with respect to the Barthel Index
timeFrame: Change from baseline to end of intervention (6 months)
measure: physical activity as measured by range of motion
timeFrame: Change from baseline to end of intervention (6 months)
measure: cognitive function
timeFrame: Change from baseline to end of intervention (6 months)
measure: Stroke specific quality of life
timeFrame: Change from baseline to end of intervention (6 months)
measure: potential cost effectiveness of the solution
timeFrame: Change from baseline to end of intervention (6 months)
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Neuro-rehabilitation Department of the University Hospital of Ancona.
city: Derry
country: United Kingdom
facility: Western Health and Social Care Trust
city: Lurgan
country: United Kingdom
facility: Southern Health and Social Care Trust
Study officials:
References: