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

Hemiparesis as Late Effect of Cerebrovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04360460
• Other study ID #: 5200147
• Status: Completed
• Phase: N/A
• Start date: December 3, 2020
• Est. completion date: August 18, 2022

Study information

• Verified date: May 2023
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 18, 2022
• Est. primary completion date: August 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. 18-90 years old

2. Hospitalized at Loma Linda East Campus Rehabilitation Hospital

3. First time stroke patient

4. Upper limb hemiparesis

5. English-speaking

6. Manual muscle testing of at least 2/5 in 3 or more muscle groups in affected upper limb

Exclusion Criteria:

1. Active neck pain, headaches, or vertigo limiting ability to tolerate Virtual Reality Head Mounted Device

2. Patients with hemicraniectomy

3. Current uncontrolled seizures

4. Active infections requiring contact precautions

5. Cognitively unable to participate

6. Vision loss limiting ability to participate with VR therapy

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Hemiparesis as Late Effect of Cerebrovascular Disease
• Paresis

Intervention

Other:
• Immersive virtual reality + related functional translation into real-life
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
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.

Locations

Country	Name	City	State
United States	Tom and Vi Zapara Rehabilitation Pavilion	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Secondary	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	Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Secondary	Fugl-Meyer Upper Extremity Assessment	Post-stroke upper extremity assessment; Very severe = 0-35 Severe = 36-55 Moderate. = 56-79 Slight = >79	Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Secondary	Montreal Cognitive Assessment	Cognitive Assessment; No cognitive impairment: MoCA = 25 Mild cognitive impairment: MoCA 20-24 Severe cognitive impairment: MoCA < 20	Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Secondary	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	Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)