Back to resultsRole of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke
Primary Purpose
Hemiparesis as Late Effect of Cerebrovascular Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immersive virtual reality + related functional translation into real-life
Immersive virtual reality + non-related translation into real-life
Sponsored by
About this trial
This is an interventional treatment trial for Hemiparesis as Late Effect of Cerebrovascular Disease
Eligibility Criteria
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
Sites / Locations
- Tom and Vi Zapara Rehabilitation Pavilion
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
Virtual reality followed by translation into related functional tasks in a real life setting for 2 weeks + conventional therapies
Virtual reality followed by translation into non-related functional tasks in a real life setting for 2 weeks + conventional therapies
Outcomes
Primary Outcome Measures
Motor Activity Log
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 Outcome Measures
Modified Barthel's Index
Quality of Life Self-Reported Questionnaire
80-100 Independent 60-79 Minimally dependent 40-59 Partially dependent 20-39 Very dependent <20 Totally dependent
Fugl-Meyer Upper Extremity Assessment
Post-stroke upper extremity assessment
Very severe = 0-35 Severe = 36-55 Moderate. = 56-79 Slight = >79
Montreal Cognitive Assessment
Cognitive Assessment
No cognitive impairment: MoCA ≥ 25 Mild cognitive impairment: MoCA 20-24 Severe cognitive impairment: MoCA < 20
Functional Independence Measurement Score
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04360460
Brief Title
Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke
Official Title
Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
August 18, 2022 (Actual)
Study Completion Date
August 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis as Late Effect of Cerebrovascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Virtual reality followed by translation into related functional tasks in a real life setting for 2 weeks + conventional therapies
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Virtual reality followed by translation into non-related functional tasks in a real life setting for 2 weeks + conventional therapies
Intervention Type
Other
Intervention Name(s)
Immersive virtual reality + related functional translation into real-life
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Immersive virtual reality + non-related translation into real-life
Intervention Description
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 Outcome Measure Information:
Title
Motor Activity Log
Description
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).
Time Frame
Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Secondary Outcome Measure Information:
Title
Modified Barthel's Index
Description
Quality of Life Self-Reported Questionnaire
80-100 Independent 60-79 Minimally dependent 40-59 Partially dependent 20-39 Very dependent <20 Totally dependent
Time Frame
Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Title
Fugl-Meyer Upper Extremity Assessment
Description
Post-stroke upper extremity assessment
Very severe = 0-35 Severe = 36-55 Moderate. = 56-79 Slight = >79
Time Frame
Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Title
Montreal Cognitive Assessment
Description
Cognitive Assessment
No cognitive impairment: MoCA ≥ 25 Mild cognitive impairment: MoCA 20-24 Severe cognitive impairment: MoCA < 20
Time Frame
Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Title
Functional Independence Measurement Score
Description
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
Time Frame
Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Tarver, MD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom and Vi Zapara Rehabilitation Pavilion
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke
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