The Feasibility, Usability, and Acceptability of Using the Oculus™ Virtual Reality Gaming Technology in Stroke Survivors for Upper Extremity and Cognitive Rehabilitation

The purpose of this study is to test the (a) feasibility, (b) usability, and (c) acceptability of using the Oculus Virtual Reality (VR) for chronic stroke survivors who have mild-moderate cognitive and unilateral arm impairment to administer upper extremity and cognitive rehabilitation, to calculate the change in upper extremity and cognition scores on standardized measurements per standard of care and to qualitatively explore the impact of engaging caregivers in supporting the stroke survivor's rehabilitation and the impact of this engagement on the stroke survivor and caregiver dyad using semi-structured interviews.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Oculus VR

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ischemic or hemorrhagic stroke diagnosis within 6 months to 2 years of enrollment
• can read, write, comprehend, speak English
• willing and able to provide informed consent
• Caregivers must live in the home with the stroke survivor

Exclusion Criteria:

• do not have score ranges that indicate mild to moderate severity on the Montreal Cognitive Assessment (MoCA )(15-25) or other appropriate cognitive screening test selected by the speech language pathologist
• has aphasia, hemiopsia, and other neurological deficits that prevents the participant from being examined using MoCA or a modified MoCA, Fugl-Meyer Assessment - Upper Extremity (FM) (20-50)
• unstable while standing unassisted
• have a history of motion sickness/ vertigo/ dizziness/seizures, claustrophobia, blind/deaf, and cannot hold the controller in their affected arm.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Oculus VR

Device: Oculus VR; During the first visit, the Oculus headset will be placed on the stroke survivor's head and demonstrate how to use the headset. participant will be then allowed to play a game using the hand controllers for up to 30 minutes. Finally, a copy of exercises for their home rehabilitation program will be provided. During the next rehabilitation visits, a trained research assistant will guide the stroke survivor with using the gaming headset. The session will be stopped every 20 minutes to make sure that the stroke survivor is feeling well and to give them a break. The stroke survivor may stop the session at any time. This session will last for an hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility as Assessed by the Number of Sessions Attended	The minimum number of sessions expected for a user are 2 per week (8 sessions)	end of intervention( about 4 weeks from baseline)
Feasibility as Assessed by the Time Spent Using the Oculus VR	the minimum time spent playing Job Simulator is 1 hour (60 minutes) per week. (240 minutes through the end of the study)	end of intervention( about 4 weeks from baseline)
Usability as Assessed by the Score on the System Usability Scale (SUS)	The System Usability Scale (SUS) was used to assess the usability of the technology. Total score ranges from 10 to 50, with a higher score indicating greater usability.	end of intervention( about 4 weeks from baseline)
Usability as Assessed by the Score on the Presence Questionnaire (PQ)	The Presence Questionnaire (PQ), total score ranges from 29 to 87, with a higher score indicating greater usability.	end of intervention( about 4 weeks from baseline)
Cognition as Assessed by the Montreal Cognitive Assessment (MoCA)	Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.	Baseline
Cognition as Assessed by the Montreal Cognitive Assessment (MoCA)	Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.	end of intervention (about 4 weeks from baseline)
Limb Function as Assessed by the Action Research Arm Test (ARAT)	Total score on the Action Research Arm Test (ARAT), ranging from 0 to 57, with higher scores indicating better upper limb function.	Baseline
Limb Function as Assessed by the Action Research Arm Test (ARAT)	Total score on the Action Research Arm Test (ARAT), ranging from 0 to 57, with higher scores indicating better upper limb function.	end of intervention( about 4 weeks from baseline)
Arm Impairment as Assessed by Fugl Meyer - Upper Extremity Assessment	Total score on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE), ranges from 0 to 66, with higher scores indicating better arm function.	Baseline
Arm Impairment as Assessed by Fugl Meyer - Upper Extremity Assessment	Total score on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE), ranges from 0 to 66, with higher scores indicating better arm function.	end of intervention( about 4 weeks from baseline)
Burden of Caregivers in Supporting the Stroke Survivor as Assessed by the Burden Scale for Family Caregivers - Short Version	Total score on the Burden Scale for Family Caregivers - short version, ranges from 0 to 30, with a higher score indicating more burden	Baseline
Burden of Caregivers in Supporting the Stroke Survivor as Assessed by the Burden Scale for Family Caregivers - Short Version	Total score on the Burden Scale for Family Caregivers - short version, ranges from 0 to 30, with a higher score indicating more burden	end of intervention( about 4 weeks from baseline)
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire	Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness	Baseline
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire	Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness	Session 1 (week 1 day 1)
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire	Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness	Session 2 (week 1 day 2)
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire	Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness	Session 3 (week 1 day 3)
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire	Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness	Session 4(week 2 day 1)
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire	Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness	Session 5 (week 2 day 2)
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire	Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness	Session 6 (week 2 day 3)
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire	Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness	Session 7 (week 3 day 1)
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire	Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness	Session 8 (week 3 day 2)
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire	Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness	Session 9 (week 3 day 3)
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire	Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness	Session 10 (week 4 day 1)
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire	Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness	Session 11 (week 4 day 2)
Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire	Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness	Session 12 (week 4 day 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of the Rehabilitation on the Participant as Assessed by the Number of Themes Derived From the Qualitative Interview	In-person, in-depth interviews will be conducted following completion of a virtual reality (VR) intervention using the Oculus Quest 2 headset for post-stroke rehabilitation. Interviews will be transcribed verbatim and a qualitative analytic process will be used to identify common themes. A codebook will be developed based on analysis of the transcripts. This outcome reflects the number of themes derived from the interviews.	Baseline
Impact of the Rehabilitation on the Caregiver as Assessed by Number of Themes Derived From the Qualitative Interview	In-person, in-depth interviews will be conducted following completion of a virtual reality (VR) intervention using the Oculus Quest 2 headset for post-stroke rehabilitation. Interviews will be transcribed verbatim and a qualitative analytic process will be used to identify common themes. A codebook will be developed based on analysis of the transcripts. This outcome reflects the number of themes derived from the interviews.	end of intervention( about 4 weeks from baseline)
Number of Subjects Who Have Received Occupational Therapy		Session 1 (week 1 day 1)
Number of Subjects Who Have Received Occupational Therapy		Session 2 (week 1 day 2)
Number of Subjects Who Have Received Occupational Therapy		Session 3 (week 1 day 3)
Number of Subjects Who Have Received Occupational Therapy		Session 4(week 2 day 1)
Number of Subjects Who Have Received Occupational Therapy		Session 5 (week 2 day 2)
Number of Subjects Who Have Received Occupational Therapy		Session 6 (week 2 day 3)
Number of Subjects Who Have Received Occupational Therapy		Session 7 (week 3 day 1)
Number of Subjects Who Have Received Occupational Therapy		Session 8 (week 3 day 2)
Number of Subjects Who Have Received Occupational Therapy		Session 9 (week 3 day 3)
Number of Subjects Who Have Received Occupational Therapy		Session 10 (week 4 day 1)
Number of Subjects Who Have Received Occupational Therapy		Session 11 (week 4 day 2)
Number of Subjects Who Have Received Occupational Therapy		Session 12 (week 4 day3 )
Number of Subjects Who Have Received Physical Therapy		Session 1 (week 1 day 1)
Number of Subjects Who Have Received Physical Therapy		Session 2 (week 1 day 2)
Number of Subjects Who Have Received Physical Therapy		Session 3 (week 1 day 3)
Number of Subjects Who Have Received Physical Therapy		Session 4(week 2 day 1)
Number of Subjects Who Have Received Physical Therapy		Session 5 (week 2 day 2)
Number of Subjects Who Have Received Physical Therapy		Session 6 (week 2 day 3)
Number of Subjects Who Have Received Physical Therapy		Session 7 (week 3 day 1)
Number of Subjects Who Have Received Physical Therapy		Session 8 (week 3 day 2)
Number of Subjects Who Have Received Physical Therapy		Session 9 (week 3 day 3)
Number of Subjects Who Have Received Physical Therapy		Session 10 (week 4 day 1)
Number of Subjects Who Have Received Physical Therapy		Session 11 (week 4 day 2)
Number of Subjects Who Have Received Physical Therapy		Session 12 (week 4 day3 )
Number of Subjects Who Have Received Speech Therapy		Session 1 (week 1 day 1)
Number of Subjects Who Have Received Speech Therapy		Session 2 (week 1 day 2)
Number of Subjects Who Have Received Speech Therapy		Session 3 (week 1 day 3)
Number of Subjects Who Have Received Speech Therapy		Session 4(week 2 day 1)
Number of Subjects Who Have Received Speech Therapy		Session 5 (week 2 day2)
Number of Subjects Who Have Received Speech Therapy		Session 6 (week 2 day 3)
Number of Subjects Who Have Received Speech Therapy		Session 7 (week 3 day 1)
Number of Subjects Who Have Received Speech Therapy		Session 8 (week 3 day 2)
Number of Subjects Who Have Received Speech Therapy		Session 9 (week 3 day 3)
Number of Subjects Who Have Received Speech Therapy		Session 10 (week 4 day 1)
Number of Subjects Who Have Received Speech Therapy		Session 11 (week 4 day 2)
Number of Subjects Who Have Received Speech Therapy		Session 12 (week 4 day 3)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: IoT and Aging in Place Joint Seed Grant
• Investigators: Principal Investigator: Seema S Aggarwal, PhD, APRN, AGNP-C, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2023
• Primary Completion (Actual): July 17, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: rehabilitation; upper limb; stroke survivor
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: HSC-SN-22-0838

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No