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StrokeNCT05672628

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

A study testing Oculus VR in people with Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Oculus VR
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
5 Mar 2023to 31 Jul 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

Other trials in United States

About this study

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.

Conditions
Stroke
Being tested
Oculus VR
Keywords
rehabilitation, upper limb, stroke survivor
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oculus VRDevice

    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.

Study groups in NCT05672628
Study groupRoleWhat they receive
Oculus VRExperimentalNot described
Receives: Device: Oculus VR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility as Assessed by the Number of Sessions Attended

    The minimum number of sessions expected for a user are 2 per week (8 sessions)

    Measured: end of intervention( about 4 weeks from baseline)

  2. 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)

    Measured: end of intervention( about 4 weeks from baseline)

  3. 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.

    Measured: end of intervention( about 4 weeks from baseline)

  4. 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.

    Measured: end of intervention( about 4 weeks from baseline)

  5. 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.

    Measured: Baseline

  6. 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.

    Measured: end of intervention (about 4 weeks from baseline)

  7. 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.

    Measured: Baseline

  8. 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.

    Measured: end of intervention( about 4 weeks from baseline)

  9. 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.

    Measured: Baseline

  10. 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.

    Measured: end of intervention( about 4 weeks from baseline)

  11. 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

    Measured: Baseline

  12. 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

    Measured: end of intervention( about 4 weeks from baseline)

  13. 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

    Measured: Baseline

  14. 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

    Measured: Session 1 (week 1 day 1)

  15. 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

    Measured: Session 2 (week 1 day 2)

  16. 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

    Measured: Session 3 (week 1 day 3)

  17. 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

    Measured: Session 4(week 2 day 1)

  18. 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

    Measured: Session 5 (week 2 day 2)

  19. 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

    Measured: Session 6 (week 2 day 3)

  20. 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

    Measured: Session 7 (week 3 day 1)

  21. 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

    Measured: Session 8 (week 3 day 2)

  22. 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

    Measured: Session 9 (week 3 day 3)

  23. 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

    Measured: Session 10 (week 4 day 1)

  24. 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

    Measured: Session 11 (week 4 day 2)

  25. 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

    Measured: Session 12 (week 4 day 3)

Secondary outcomes (38)
  1. 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.

    Measured: Baseline

  2. 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.

    Measured: end of intervention( about 4 weeks from baseline)

  3. Number of Subjects Who Have Received Occupational Therapy

    Measured: Session 1 (week 1 day 1)

  4. Number of Subjects Who Have Received Occupational Therapy

    Measured: Session 2 (week 1 day 2)

  5. Number of Subjects Who Have Received Occupational Therapy

    Measured: Session 3 (week 1 day 3)

  6. Number of Subjects Who Have Received Occupational Therapy

    Measured: Session 4(week 2 day 1)

  7. Number of Subjects Who Have Received Occupational Therapy

    Measured: Session 5 (week 2 day 2)

  8. Number of Subjects Who Have Received Occupational Therapy

    Measured: Session 6 (week 2 day 3)

  9. Number of Subjects Who Have Received Occupational Therapy

    Measured: Session 7 (week 3 day 1)

  10. Number of Subjects Who Have Received Occupational Therapy

    Measured: Session 8 (week 3 day 2)

  11. Number of Subjects Who Have Received Occupational Therapy

    Measured: Session 9 (week 3 day 3)

  12. Number of Subjects Who Have Received Occupational Therapy

    Measured: Session 10 (week 4 day 1)

  13. Number of Subjects Who Have Received Occupational Therapy

    Measured: Session 11 (week 4 day 2)

  14. Number of Subjects Who Have Received Occupational Therapy

    Measured: Session 12 (week 4 day3 )

  15. Number of Subjects Who Have Received Physical Therapy

    Measured: Session 1 (week 1 day 1)

  16. Number of Subjects Who Have Received Physical Therapy

    Measured: Session 2 (week 1 day 2)

  17. Number of Subjects Who Have Received Physical Therapy

    Measured: Session 3 (week 1 day 3)

  18. Number of Subjects Who Have Received Physical Therapy

    Measured: Session 4(week 2 day 1)

  19. Number of Subjects Who Have Received Physical Therapy

    Measured: Session 5 (week 2 day 2)

  20. Number of Subjects Who Have Received Physical Therapy

    Measured: Session 6 (week 2 day 3)

  21. Number of Subjects Who Have Received Physical Therapy

    Measured: Session 7 (week 3 day 1)

  22. Number of Subjects Who Have Received Physical Therapy

    Measured: Session 8 (week 3 day 2)

  23. Number of Subjects Who Have Received Physical Therapy

    Measured: Session 9 (week 3 day 3)

  24. Number of Subjects Who Have Received Physical Therapy

    Measured: Session 10 (week 4 day 1)

  25. Number of Subjects Who Have Received Physical Therapy

    Measured: Session 11 (week 4 day 2)

  26. Number of Subjects Who Have Received Physical Therapy

    Measured: Session 12 (week 4 day3 )

  27. Number of Subjects Who Have Received Speech Therapy

    Measured: Session 1 (week 1 day 1)

  28. Number of Subjects Who Have Received Speech Therapy

    Measured: Session 2 (week 1 day 2)

  29. Number of Subjects Who Have Received Speech Therapy

    Measured: Session 3 (week 1 day 3)

  30. Number of Subjects Who Have Received Speech Therapy

    Measured: Session 4(week 2 day 1)

  31. Number of Subjects Who Have Received Speech Therapy

    Measured: Session 5 (week 2 day2)

  32. Number of Subjects Who Have Received Speech Therapy

    Measured: Session 6 (week 2 day 3)

  33. Number of Subjects Who Have Received Speech Therapy

    Measured: Session 7 (week 3 day 1)

  34. Number of Subjects Who Have Received Speech Therapy

    Measured: Session 8 (week 3 day 2)

  35. Number of Subjects Who Have Received Speech Therapy

    Measured: Session 9 (week 3 day 3)

  36. Number of Subjects Who Have Received Speech Therapy

    Measured: Session 10 (week 4 day 1)

  37. Number of Subjects Who Have Received Speech Therapy

    Measured: Session 11 (week 4 day 2)

  38. Number of Subjects Who Have Received Speech Therapy

    Measured: Session 12 (week 4 day 3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2023
  2. Study start5 Mar 2023
  3. Primary completion17 Jul 2024
  4. Study completion31 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05672628
Sponsor's protocol ID
HSC-SN-22-0838
Status last verified
Jul 2025
First submitted
20 Dec 2022
Last updated
17 Aug 2025
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Oculus VR in people with Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility as Assessed by the Number of Sessions Attended (time frame: end of intervention( about 4 weeks from baseline)). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.

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