Magic Glass Evaluation in People With Stroke

NCT04307108 | Unknown

• 1 other identifier: 18/NI/0080
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 3

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.

Conditions

Stroke

Keywords

stroke, virtual reality, upper limb

Outcome Measures

Primary Outcomes (7)

• 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

  through study completion, an average of 6 months

• the usability of the intervention

  System usability score questionnaire

  through study completion, an average of 6 months

• 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

  through study completion, an average of 6 months

• the process requirements for the new care pathway;

  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;

  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

  measured in clinical dashboard

  Change from baseline to end of intervention (6 months)

• the duration in Rehabilitation Therapy

  measured in clinical dashboard

  Change from baseline to end of intervention (6 months)

Secondary Outcomes (6)

• Functional independence in the activities of daily living with respect to the modified Rankin Scale

  Change from baseline to end of intervention (6 months)

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

  Change from baseline to end of intervention (6 months)

• physical activity as measured by range of motion

  Change from baseline to end of intervention (6 months)

• cognitive function

  Change from baseline to end of intervention (6 months)

• Stroke specific quality of life

  Change from baseline to end of intervention (6 months)

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Those with upper limb sensory disturbance who are unwilling to keep their nails short for the duration of the study.

Sponsors & Collaborators

• University of Ulster: lead
• Western Health and Social Care Trust: collaborator
• Southern Health and Social Care Trust: collaborator
• Tech 4 Care: collaborator
• miThings AB: collaborator

Study Sites (3)

Neuro-rehabilitation Department of the University Hospital of Ancona.

Ancona, Italy

RECRUITING

Western Health and Social Care Trust

Londonderry, United Kingdom

RECRUITING

Southern Health and Social Care Trust

Lurgan, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Aoife Stephenson, PhD

CONTACT

02890368895; a.stephenson@ulster.ac.uk

Suzanne McDonough, PhD

CONTACT

SuzanneMcDonough@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: March 13, 2020
• Study Start: November 11, 2018
• Primary Completion: March 30, 2020
• Study Completion: June 10, 2020
• Last Updated: March 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); GB (2)