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OpenTrials
Completed

NCT Number: NCT04360460

Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke

This is a single-blinded randomized control trial aiming to explore the use of immersive virtual reality (VR) training in conjunction with real-life tasks therapy in 75 first time stroke patients with upper limb weakness.

Completed

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Key information

Conditions

Hemiparesis as Late Effect of Cerebrovascular Disease

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tom and Vi Zapara Rehabilitation Pavilion

Loma Linda, California, 92354, United States

About this study

Patients will be randomized to a control or experimental group. The experimental group will receive immersive VR training followed by the translation of related tasks in a real life environment. The control group will perform the same tasks in a real life environment but will receive immersive VR exposure to a non-related task.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-90 years old
  • Hospitalized at Loma Linda East Campus Rehabilitation Hospital
  • First time stroke patient
  • Upper limb hemiparesis
  • English-speaking
  • Manual muscle testing of at least 2/5 in 3 or more muscle groups in affected upper limb

Exclusion criteria

  • Active neck pain, headaches, or vertigo limiting ability to tolerate Virtual Reality Head Mounted Device
  • Patients with hemicraniectomy
  • Current uncontrolled seizures
  • Active infections requiring contact precautions
  • Cognitively unable to participate
  • Vision loss limiting ability to participate with VR therapy

Treatment and study plan

Immersive virtual reality + related functional translation into real-life

Other

The experimental group will perform tasks in an immersive virtual reality setting designed to encourage functional task performance for 30 minutes. The patient will then be brought to a real-life setting and evaluated on similar task performances for an additional 30 minutes for a total of 60 minutes per day, 3 times a week for 2 weeks.

Immersive virtual reality + non-related translation into real-life

Other

The control group will also be asked to perform tasks in an immersive VR setting for 30 minutes, however tasks will be unrelated to the tasks performed in the real-life setting in the following 30 minutes. The control group will also receive 60 minutes of therapy a day, 3 times a week, for 2 weeks.

Primary outcomes

  1. Motor Activity Log

    Time frame: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)

    ADL Self-Reported Questionnaire

    Amount Scale (0-5) 0 = Did not use my weaker arm (not used) 5 = Used my weaker arm as often as before the stroke (same as pre-stroke).

    How well scale (0-5) 0 - My weaker arm was not used at all for that activity (not used). 5 - The ability to use my weaker arm for that activity was as good as before the stroke (normal).

Secondary outcomes

  1. Modified Barthel's Index

    Time frame: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)

    Quality of Life Self-Reported Questionnaire

    80-100 Independent 60-79 Minimally dependent 40-59 Partially dependent 20-39 Very dependent <20 Totally dependent

  2. Fugl-Meyer Upper Extremity Assessment

    Time frame: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)

    Post-stroke upper extremity assessment

    Very severe = 0-35 Severe = 36-55 Moderate. = 56-79 Slight = >79

  3. Montreal Cognitive Assessment

    Time frame: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)

    Cognitive Assessment

    No cognitive impairment: MoCA ≥ 25 Mild cognitive impairment: MoCA 20-24 Severe cognitive impairment: MoCA < 20

  4. Functional Independence Measurement Score

    Time frame: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)

    Functional evaluation

    7 - complete independence 6 - modified indepdendence 5 - supervision/Setup 4 - minimal contact assistance 3 - moderate assistance 2 - maximal assistance

    1 - total assistance 0 - activity does not occur

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 24, 2020
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.