Skip to main content
OpenTrials
Completed

NCT Number: NCT05672628

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Oculus VR

Device

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.

Primary outcomes

  1. Feasibility as Assessed by the Number of Sessions Attended

    Time frame: end of intervention( about 4 weeks from baseline)

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

  2. Feasibility as Assessed by the Time Spent Using the Oculus VR

    Time frame: end of intervention( about 4 weeks from baseline)

    the minimum time spent playing Job Simulator is 1 hour (60 minutes) per week. (240 minutes through the end of the study)

  3. Usability as Assessed by the Score on the System Usability Scale (SUS)

    Time frame: end of intervention( about 4 weeks from baseline)

    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.

  4. Usability as Assessed by the Score on the Presence Questionnaire (PQ)

    Time frame: end of intervention( about 4 weeks from baseline)

    The Presence Questionnaire (PQ), total score ranges from 29 to 87, with a higher score indicating greater usability.

  5. Cognition as Assessed by the Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline

    Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.

  6. Cognition as Assessed by the Montreal Cognitive Assessment (MoCA)

    Time frame: end of intervention (about 4 weeks from baseline)

    Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.

  7. Limb Function as Assessed by the Action Research Arm Test (ARAT)

    Time frame: Baseline

    Total score on the Action Research Arm Test (ARAT), ranging from 0 to 57, with higher scores indicating better upper limb function.

  8. Limb Function as Assessed by the Action Research Arm Test (ARAT)

    Time frame: end of intervention( about 4 weeks from baseline)

    Total score on the Action Research Arm Test (ARAT), ranging from 0 to 57, with higher scores indicating better upper limb function.

  9. Arm Impairment as Assessed by Fugl Meyer - Upper Extremity Assessment

    Time frame: Baseline

    Total score on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE), ranges from 0 to 66, with higher scores indicating better arm function.

  10. Arm Impairment as Assessed by Fugl Meyer - Upper Extremity Assessment

    Time frame: end of intervention( about 4 weeks from baseline)

    Total score on the Fugl-Meyer Assessment - Upper Extremity (FMA-UE), ranges from 0 to 66, with higher scores indicating better arm function.

  11. Burden of Caregivers in Supporting the Stroke Survivor as Assessed by the Burden Scale for Family Caregivers - Short Version

    Time frame: Baseline

    Total score on the Burden Scale for Family Caregivers - short version, ranges from 0 to 30, with a higher score indicating more burden

  12. Burden of Caregivers in Supporting the Stroke Survivor as Assessed by the Burden Scale for Family Caregivers - Short Version

    Time frame: end of intervention( about 4 weeks from baseline)

    Total score on the Burden Scale for Family Caregivers - short version, ranges from 0 to 30, with a higher score indicating more burden

  13. Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire

    Time frame: Baseline

    Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness

  14. Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire

    Time frame: Session 1 (week 1 day 1)

    Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness

  15. Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire

    Time frame: Session 2 (week 1 day 2)

    Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness

  16. Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire

    Time frame: Session 3 (week 1 day 3)

    Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness

  17. Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire

    Time frame: Session 4(week 2 day 1)

    Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness

  18. Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire

    Time frame: Session 5 (week 2 day 2)

    Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness

  19. Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire

    Time frame: Session 6 (week 2 day 3)

    Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness

  20. Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire

    Time frame: Session 7 (week 3 day 1)

    Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness

  21. Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire

    Time frame: Session 8 (week 3 day 2)

    Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness

  22. Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire

    Time frame: Session 9 (week 3 day 3)

    Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness

  23. Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire

    Time frame: Session 10 (week 4 day 1)

    Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness

  24. Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire

    Time frame: Session 11 (week 4 day 2)

    Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness

  25. Acceptability (Ease of Use) as Assessed by the Score on the Simulator Sickness Questionnaire (SSQ) Questionnaire

    Time frame: Session 12 (week 4 day 3)

    Total score on the Simulator Sickness Questionnaire (SSQ) questionnaire ranges from 16 to 64, a higher score indicating more cybersickness

Secondary outcomes

  1. Impact of the Rehabilitation on the Participant as Assessed by the Number of Themes Derived From the Qualitative Interview

    Time frame: Baseline

    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.

  2. Impact of the Rehabilitation on the Caregiver as Assessed by Number of Themes Derived From the Qualitative Interview

    Time frame: end of intervention( about 4 weeks from baseline)

    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.

  3. Number of Subjects Who Have Received Occupational Therapy

    Time frame: Session 1 (week 1 day 1)

  4. Number of Subjects Who Have Received Occupational Therapy

    Time frame: Session 2 (week 1 day 2)

  5. Number of Subjects Who Have Received Occupational Therapy

    Time frame: Session 3 (week 1 day 3)

  6. Number of Subjects Who Have Received Occupational Therapy

    Time frame: Session 4(week 2 day 1)

  7. Number of Subjects Who Have Received Occupational Therapy

    Time frame: Session 5 (week 2 day 2)

  8. Number of Subjects Who Have Received Occupational Therapy

    Time frame: Session 6 (week 2 day 3)

  9. Number of Subjects Who Have Received Occupational Therapy

    Time frame: Session 7 (week 3 day 1)

  10. Number of Subjects Who Have Received Occupational Therapy

    Time frame: Session 8 (week 3 day 2)

  11. Number of Subjects Who Have Received Occupational Therapy

    Time frame: Session 9 (week 3 day 3)

  12. Number of Subjects Who Have Received Occupational Therapy

    Time frame: Session 10 (week 4 day 1)

  13. Number of Subjects Who Have Received Occupational Therapy

    Time frame: Session 11 (week 4 day 2)

  14. Number of Subjects Who Have Received Occupational Therapy

    Time frame: Session 12 (week 4 day3 )

  15. Number of Subjects Who Have Received Physical Therapy

    Time frame: Session 1 (week 1 day 1)

  16. Number of Subjects Who Have Received Physical Therapy

    Time frame: Session 2 (week 1 day 2)

  17. Number of Subjects Who Have Received Physical Therapy

    Time frame: Session 3 (week 1 day 3)

  18. Number of Subjects Who Have Received Physical Therapy

    Time frame: Session 4(week 2 day 1)

  19. Number of Subjects Who Have Received Physical Therapy

    Time frame: Session 5 (week 2 day 2)

  20. Number of Subjects Who Have Received Physical Therapy

    Time frame: Session 6 (week 2 day 3)

  21. Number of Subjects Who Have Received Physical Therapy

    Time frame: Session 7 (week 3 day 1)

  22. Number of Subjects Who Have Received Physical Therapy

    Time frame: Session 8 (week 3 day 2)

  23. Number of Subjects Who Have Received Physical Therapy

    Time frame: Session 9 (week 3 day 3)

  24. Number of Subjects Who Have Received Physical Therapy

    Time frame: Session 10 (week 4 day 1)

  25. Number of Subjects Who Have Received Physical Therapy

    Time frame: Session 11 (week 4 day 2)

  26. Number of Subjects Who Have Received Physical Therapy

    Time frame: Session 12 (week 4 day3 )

  27. Number of Subjects Who Have Received Speech Therapy

    Time frame: Session 1 (week 1 day 1)

  28. Number of Subjects Who Have Received Speech Therapy

    Time frame: Session 2 (week 1 day 2)

  29. Number of Subjects Who Have Received Speech Therapy

    Time frame: Session 3 (week 1 day 3)

  30. Number of Subjects Who Have Received Speech Therapy

    Time frame: Session 4(week 2 day 1)

  31. Number of Subjects Who Have Received Speech Therapy

    Time frame: Session 5 (week 2 day2)

  32. Number of Subjects Who Have Received Speech Therapy

    Time frame: Session 6 (week 2 day 3)

  33. Number of Subjects Who Have Received Speech Therapy

    Time frame: Session 7 (week 3 day 1)

  34. Number of Subjects Who Have Received Speech Therapy

    Time frame: Session 8 (week 3 day 2)

  35. Number of Subjects Who Have Received Speech Therapy

    Time frame: Session 9 (week 3 day 3)

  36. Number of Subjects Who Have Received Speech Therapy

    Time frame: Session 10 (week 4 day 1)

  37. Number of Subjects Who Have Received Speech Therapy

    Time frame: Session 11 (week 4 day 2)

  38. Number of Subjects Who Have Received Speech Therapy

    Time frame: Session 12 (week 4 day 3)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • IoT and Aging in Place Joint Seed Grant

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2023
Registry last updated
Aug 17, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.