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StrokeNCT04307108

Magic Glass Evaluation in People With Stroke

A study testing Magic Glass in people with Stroke, run by University of Ulster at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 investigators introduce this technology there is a need to test that it will work alongside current health services for stroke survivors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Magic Glass
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
3 sitesin 2 countries
Study dates
11 Nov 2018to 10 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • • 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.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United Kingdom2 sites
  • Western Health and Social Care Trust

    Londonderry

  • Southern Health and Social Care Trust

    Lurgan

Other trials in United Kingdom

Italy1 site
  • Neuro-rehabilitation Department of the University Hospital of Ancona.

    Ancona

Other trials in Italy

About this study

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

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 investigators introduce this technology there is a 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. Participants 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: The investigators want to find out how the stroke survivors' movement changes over time and what they think of using the system. Investigators will also ask clinical staff what they thought of using the system as part of healthcare provision to stroke survivors. Finally investigators want to find out how much it will cost to use the system.

Conditions
Stroke
Being tested
Magic Glass
Keywords
stroke, virtual reality, upper limb
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magic GlassDevice

    MAGIC-GLASS is a VR-based home system for stroke rehabilitation, developed by Ulster University (UK) in collaboration with Tech4Care srl (Italy) and miThings AB (Sweden) in the context of the EU-funded Project Magic (grant agreement No 687228). It includes a number of mini-games grounded on rehabilitation paradigms such as mirror therapy [29] and can adapt to the capability of a person. In addition, the games will include an automatic coaching system for giving feedback both on rehabilitation results (e.g. achievement of exercise goals) and performance (during the exercise itself, the system will give real time advice on the execution of the exercise).

Study groups in NCT04307108
Study groupRoleWhat they receive
VR interventionExperimentalEach participant received an individualised UL training programme focusing on gross and fine motor movements via the MAGIC -GLASS system, using a VR headset followed by fortnightly remote clinical contacts up to month six.
Receives: Device: Magic Glass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the usability of the intervention;

    Combination of interviews with users, carer questionnaire, focus groups with clinicians will be used to assess usability using qualitative analysis

    Measured: through study completion, an average of 6 months

  2. the usability of the intervention

    System usability score questionnaire

    Measured: through study completion, an average of 6 months

  3. the acceptability of the intervention

    Combination of interviews with users, carer questionnaire, focus groups with clinicians will be used to assess acceptability by analysing qualitatively

    Measured: through study completion, an average of 6 months

  4. the process requirements for the new care pathway;

    Combination of interviews with users, carer questionnaire, focus groups with clinicians and will be analysed qualitatively

    Measured: through study completion, an average of 6 months

  5. the resource requirements for the new care pathway;

    Combination of interviews with users, carer questionnaire, focus groups with clinician and will be analysed qualitatively

    Measured: through study completion, an average of 6 months

  6. the intensity in Rehabilitation Therapy

    measured in clinical dashboard

    Measured: Change from baseline to end of intervention (6 months)

  7. the duration in Rehabilitation Therapy

    measured in clinical dashboard

    Measured: Change from baseline to end of intervention (6 months)

Secondary outcomes (5)
  1. Functional independence in the activities of daily living with respect to the Modified Rankin Scale

    Scale of 0-6 with a higher number representing worse disability

    Measured: Change from baseline to end of intervention (6 months)

  2. Functional independence in the activities of daily living with respect to the Barthel Index

    Scale of 0-100 where a higher number indicates more independence

    Measured: Change from baseline to end of intervention (6 months)

  3. physical activity as measured by Range of Motion

    measured by sensors inbuilt in the computer system. A scale of 0-360 degrees with a higher score representing more range of motion

    Measured: Change from baseline to end of intervention (6 months)

  4. Cognitive function measured by the Montreal Cognitive Assessment

    Score of 0-30 with a higher score indicating more cognitive decline

    Measured: Change from baseline to end of intervention (6 months)

  5. Stroke specific quality of life questionnaire

    Score range of 49-245 with a higher score indicating better quality of life

    Measured: Change from baseline to end of intervention (6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2020
  2. Study start11 Nov 2018
  3. Primary completion30 Mar 2020
  4. Study completion10 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04307108
Sponsor's protocol ID
18/NI/0080
Status last verified
Mar 2020
First submitted
17 Feb 2020
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Magic Glass in people with Stroke, run by University of Ulster at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the usability of the intervention; (time frame: through study completion, an average of 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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Magic Glass Evaluation in People With Stroke | AzTrials