Magic Glass Evaluation in People With Stroke

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04307108
• Other study ID #: 18/NI/0080
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2018
• Est. completion date: June 10, 2020

Study information

• Verified date: March 2020
• Source: University of Ulster
• Contact: Aoife Stephenson, PhD
• Phone: 02890368895
• Email: a.stephenson[@]ulster.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 10, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Magic Glass
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).

Locations

Country	Name	City	State
Italy	Neuro-rehabilitation Department of the University Hospital of Ancona.	Ancona
United Kingdom	Western Health and Social Care Trust	Derry
United Kingdom	Southern Health and Social Care Trust	Lurgan

Sponsors (5)

Lead Sponsor	Collaborator
University of Ulster	miThings AB, Southern Health and Social Care Trust, Tech 4 Care, Western Health and Social Care Trust

Countries where clinical trial is conducted

Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	the usability of the intervention	System usability score questionnaire	through study completion, an average of 6 months
Primary	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
Primary	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
Primary	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
Primary	the intensity in Rehabilitation Therapy	measured in clinical dashboard	Change from baseline to end of intervention (6 months)
Primary	the duration in Rehabilitation Therapy	measured in clinical dashboard	Change from baseline to end of intervention (6 months)
Secondary	Functional independence in the activities of daily living with respect to the modified Rankin Scale		Change from baseline to end of intervention (6 months)
Secondary	Functional independence in the activities of daily living with respect to the Barthel Index		Change from baseline to end of intervention (6 months)
Secondary	physical activity as measured by range of motion	measured by sensors inbuilt in the computer system	Change from baseline to end of intervention (6 months)
Secondary	cognitive function	Montreal Cognitive Assessment	Change from baseline to end of intervention (6 months)
Secondary	Stroke specific quality of life	Stroke specific quality of life questionnaire	Change from baseline to end of intervention (6 months)
Secondary	potential cost effectiveness of the solution	health care resource questionnaire	Change from baseline to end of intervention (6 months)