Magic Glass Evaluation in People With Stroke

March 10, 2020 updated by: University of Ulster

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 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 6 months
the usability of the intervention
Time Frame: through study completion, an average of 6 months
System usability score questionnaire
through study completion, an average of 6 months
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
through study completion, an average of 6 months
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
through study completion, an average of 6 months
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
through study completion, an average of 6 months
the intensity in Rehabilitation Therapy
Time Frame: Change from baseline to end of intervention (6 months)
measured in clinical dashboard
Change from baseline to end of intervention (6 months)
the duration in Rehabilitation Therapy
Time Frame: Change from baseline to end of intervention (6 months)
measured in clinical dashboard
Change from baseline to end of intervention (6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline to end of intervention (6 months)
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)
Change from baseline to end of intervention (6 months)
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
Change from baseline to end of intervention (6 months)
cognitive function
Time Frame: Change from baseline to end of intervention (6 months)
Montreal Cognitive Assessment
Change from baseline to end of intervention (6 months)
Stroke specific quality of life
Time Frame: Change from baseline to end of intervention (6 months)
Stroke specific quality of life questionnaire
Change from baseline to end of intervention (6 months)
potential cost effectiveness of the solution
Time Frame: Change from baseline to end of intervention (6 months)
health care resource questionnaire
Change from baseline to end of intervention (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulster

Collaborators

Western Health and Social Care Trust
Southern Health and Social Care Trust
Tech 4 Care
miThings AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2018

Primary Completion (Anticipated)

March 30, 2020

Study Completion (Anticipated)

June 10, 2020

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 13, 2020

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18/NI/0080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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