The Feasibility, Usability, and Acceptability of Using the Oculus™ Virtual Reality Gaming Technology in Stroke Survivors for Upper Extremity and Cognitive Rehabilitation
- Conditions
- Stroke
- Interventions
- Device: Oculus VR
- Registration Number
- NCT05672628
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Oculus VR Oculus VR -
- Primary Outcome Measures
Name Time Method Feasibility as assessed by the number of sessions attended end of intervention( about 4 weeks from baseline) The minimum number of sessions expected for a user are 2 per week (8 sessions)
Usability as assessed by the score on the Presence Questionnaire (PQ) end of intervention( about 4 weeks from baseline) This is a 29 item questionnaire that uses the seven-point Likert-type scale, with 1 being the lowest and 7 the highest level of presence.
Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA) Baseline, 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.
Usability as assessed by the score on the System Usability scale (SUS) end of intervention( about 4 weeks from baseline) This is a 10 item questionnaire and each is scored from 1(strongly disagree) to 5(strongly agree). To calculate the total score, the score contributions from each item will be summed up.Each item's score contribution will range from 0 to 4. For items 1,3,5,7,and 9 the score contribution is the scale position minus 1. For items 2,4,6,8 and 10, the contribution is 5 minus the scale position. Then the sum of the scores will be multiplied by 2.5 to obtain the overall value of SU.SUS scores have a range of 0 to 100, a higher number indicating better usability
Feasibility as assessed by the time spent using the Oculus VR end of intervention( about 4 weeks from baseline) the minimum time spent playing Job Simulator is 1 hour per week (4 hours)
Change in arm impairment as assessed by Fugl Meyer - Upper Extremity assessment Baseline, end of intervention( about 4 weeks from baseline) This is a 33 item assessment and each is scored from 0 \[unable to perform as instructed\] - 2 \[faultless performance\] with a maximum score of 66. A higher number indicates better arm function.
Change in burden of caregivers in supporting the stroke survivor as assessed by the Burden Scale for Family Caregivers - short version Baseline, end of intervention( about 4 weeks from baseline) This is a 10 item questionnaire and each is scored on a 4 point scale from (0) strongly disagree to (3) strongly agree a higher score indicating more burden
Acceptability (ease of use) as assessed by the score on the Simulator Sickness Questionnaire (SSQ) questionnaire Baseline, after each session (3 times a week for 4 weeks about 12 total sessions) This is a 16 item questionnaire that capture physical symptoms commonly associated with prolonged activity in a simulator. Each symptom is ranked in order of effect on the user (0=none, 1=slight, 2=moderate, 3=severe.) a higher score indicating more cybersickness
Change in limb function as assessed by the Action Research Arm Test (ARAT) Baseline, end of intervention( about 4 weeks from baseline) The ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement. Each is scored from 0(can not perform any part of the test) to 3 (performs the test normally) for a maximum score of 57, high scores showing more ability to perform normally.
- Secondary Outcome Measures
Name Time Method Number of subjects who have received occupational therapy Session 12 (week 4 day3 ) Number of subjects who have received speech therapy Session 12 (week 4 day 3) Change in Impact of the rehabilitation on the participant as assessed by the qualitative interview Baseline, end of intervention (about 4 weeks from baseline) Change in Impact of the rehabilitation on the caregiver as assessed by the qualitative interview Baseline, end of intervention( about 4 weeks from baseline) Number of subjects who have received physical therapy Session 12 (week 4 day3 )
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States