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

NCT05672628 | Completed Results FDA Device

• 1 other identifier: HSC-SN-22-0838
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

rehabilitation; upper limb; stroke survivor

Outcome Measures

Primary Outcomes (25)

• 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 Outcomes (38)

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

  Baseline

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

  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)

Study Arms (1)

Oculus VR

EXPERIMENTAL

Device: Oculus VR

Interventions

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.

Oculus VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• IoT and Aging in Place Joint Seed Grant: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Seema S Aggarwal, PhD, APRN, AGNP-C
• Organization: The University of Texas Health Science Center at Houston

Seema.S.Aggarwal@uth.tmc.edu

713-500-9946

Study Officials

• Seema S Aggarwal, PhD, APRN, AGNP-C

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 5, 2023
• Study Start: March 5, 2023
• Primary Completion: July 17, 2024
• Study Completion: July 31, 2024
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)