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Magic Glass Evaluation in People With Stroke

Primary Purpose

Stroke

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Magic Glass

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, virtual reality, upper limb

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Neuro-rehabilitation Department of the University Hospital of Ancona.Recruiting
Western Health and Social Care TrustRecruiting
Southern Health and Social Care TrustRecruiting

Outcomes

Primary Outcome Measures

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

the usability of the intervention

System usability score questionnaire

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

the process requirements for the new care pathway;

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

the resource requirements for the new care pathway;

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

the intensity in Rehabilitation Therapy

measured in clinical dashboard

the duration in Rehabilitation Therapy

measured in clinical dashboard

Secondary Outcome Measures

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

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

physical activity as measured by range of motion

measured by sensors inbuilt in the computer system

cognitive function

Montreal Cognitive Assessment

Stroke specific quality of life

Stroke specific quality of life questionnaire

potential cost effectiveness of the solution

health care resource questionnaire

Full Information

NCT ID

NCT04307108

First Posted

February 17, 2020

Last Updated

March 10, 2020

Sponsor

University of Ulster

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04307108

Brief Title

Magic Glass Evaluation in People With Stroke

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 11, 2018 (Actual)

Primary Completion Date

March 30, 2020 (Anticipated)

Study Completion Date

June 10, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Ulster

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

stroke, virtual reality, upper limb

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Magic Glass

Intervention Description

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 Outcome Measure Information:

Title

the usability of the intervention;

Description

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

Time Frame

through study completion, an average of 6 months

Title

the usability of the intervention

Description

System usability score questionnaire

Time Frame

through study completion, an average of 6 months

Title

the acceptability of the intervention

Description

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

Time Frame

through study completion, an average of 6 months

Title

the process requirements for the new care pathway;

Description

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

Time Frame

through study completion, an average of 6 months

Title

the resource requirements for the new care pathway;

Description

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

Time Frame

through study completion, an average of 6 months

Title

the intensity in Rehabilitation Therapy

Description

measured in clinical dashboard

Time Frame