Status:

UNKNOWN

Magic Glass Evaluation in People With Stroke

Lead Sponsor:

University of Ulster

Collaborating Sponsors:

Western Health and Social Care Trust

Southern Health and Social Care Trust

Conditions:

Stroke

Eligibility:

All Genders

18+ years

Phase:

NA

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 n...

Eligibility Criteria

Inclusion

  • 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

  • • 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.

Key Trial Info

Start Date :

November 11 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 10 2020

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT04307108

Start Date

November 11 2018

End Date

June 10 2020

Last Update

March 13 2020

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Neuro-rehabilitation Department of the University Hospital of Ancona.

Ancona, Italy

2

Western Health and Social Care Trust

Londonderry, United Kingdom

3

Southern Health and Social Care Trust

Lurgan, United Kingdom