Skip to main content
OpenTrials
Completed

NCT Number: NCT04307108

Magic Glass Evaluation in People With 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neuro-rehabilitation Department of the University Hospital of Ancona., Ancona, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magic Glass

Device

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).

Primary outcomes

  1. the usability of the intervention;

    Time frame: through study completion, an average of 6 months

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

  2. the usability of the intervention

    Time frame: through study completion, an average of 6 months

    System usability score questionnaire

  3. the acceptability of the intervention

    Time frame: through study completion, an average of 6 months

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

  4. the process requirements for the new care pathway;

    Time frame: through study completion, an average of 6 months

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

  5. the resource requirements for the new care pathway;

    Time frame: through study completion, an average of 6 months

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

  6. the intensity in Rehabilitation Therapy

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

    measured in clinical dashboard

  7. the duration in Rehabilitation Therapy

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

    measured in clinical dashboard

Secondary outcomes

  1. Functional independence in the activities of daily living with respect to the Modified Rankin Scale

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

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

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

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

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

  3. physical activity as measured by Range of Motion

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

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

  4. Cognitive function measured by the Montreal Cognitive Assessment

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

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

  5. Stroke specific quality of life questionnaire

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

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

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • Southern Health and Social Care Trust
  • Western Health and Social Care Trust

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 13, 2020
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.