Back to resultsThe Feasibility, Usability, and Acceptability of Using the Oculus™ Virtual Reality Gaming Technology in Stroke Survivors for Upper Extremity and Cognitive Rehabilitation
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oculus VR
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring rehabilitation, upper limb, stroke survivor
Eligibility Criteria
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.
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oculus VR
Arm Description
Outcomes
Primary Outcome Measures
Feasibility as assessed by the number of sessions attended
The minimum number of sessions expected for a user are 2 per week (8 sessions)
Feasibility as assessed by the time spent using the Oculus VR
the minimum time spent playing Job Simulator is 1 hour per week (4 hours)
Usability as assessed by the score on the System Usability scale (SUS)
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
Usability as assessed by the score on the Presence Questionnaire (PQ)
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.
Acceptability (ease of use) as assessed by the score on the Simulator Sickness Questionnaire (SSQ) questionnaire
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 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.
Change in limb function as assessed by the Action Research Arm Test (ARAT)
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.
Change in arm impairment as assessed by Fugl Meyer - Upper Extremity assessment
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
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
Secondary Outcome Measures
Change in Impact of the rehabilitation on the participant as assessed by the qualitative interview
Change in Impact of the rehabilitation on the caregiver as assessed by the qualitative interview
Number of subjects who have received occupational therapy
Number of subjects who have received occupational therapy
Number of subjects who have received occupational therapy
Number of subjects who have received occupational therapy
Number of subjects who have received occupational therapy
Number of subjects who have received occupational therapy
Number of subjects who have received occupational therapy
Number of subjects who have received occupational therapy
Number of subjects who have received occupational therapy
Number of subjects who have received occupational therapy
Number of subjects who have received occupational therapy
Number of subjects who have received occupational therapy
Number of subjects who have received physical therapy
Number of subjects who have received physical therapy
Number of subjects who have received physical therapy
Number of subjects who have received physical therapy
Number of subjects who have received physical therapy
Number of subjects who have received physical therapy
Number of subjects who have received physical therapy
Number of subjects who have received physical therapy
Number of subjects who have received physical therapy
Number of subjects who have received physical therapy
Number of subjects who have received physical therapy
Number of subjects who have received physical therapy
Number of subjects who have received speech therapy
Number of subjects who have received speech therapy
Number of subjects who have received speech therapy
Number of subjects who have received speech therapy
Number of subjects who have received speech therapy
Number of subjects who have received speech therapy
Number of subjects who have received speech therapy
Number of subjects who have received speech therapy
Number of subjects who have received speech therapy
Number of subjects who have received speech therapy
Number of subjects who have received speech therapy
Number of subjects who have received speech therapy
Full Information
NCT ID
NCT05672628
First Posted
December 20, 2022
Last Updated
April 7, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
IoT and Aging in Place Joint Seed Grant
1. Study Identification
Unique Protocol Identification Number
NCT05672628
Brief Title
The Feasibility, Usability, and Acceptability of Using the Oculus™ Virtual Reality Gaming Technology in Stroke Survivors for Upper Extremity and Cognitive Rehabilitation
Official Title
The Feasibility, Usability, and Acceptability of Using the Oculus™ Virtual Reality Gaming Technology in Stroke Survivors for Upper Extremity and Cognitive Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
IoT and Aging in Place Joint Seed Grant
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
rehabilitation, upper limb, stroke survivor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oculus VR
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Oculus VR
Intervention Description
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 Outcome Measure Information:
Title
Feasibility as assessed by the number of sessions attended
Description
The minimum number of sessions expected for a user are 2 per week (8 sessions)
Time Frame
end of intervention( about 4 weeks from baseline)
Title
Feasibility as assessed by the time spent using the Oculus VR
Description
the minimum time spent playing Job Simulator is 1 hour per week (4 hours)
Time Frame
end of intervention( about 4 weeks from baseline)
Title
Usability as assessed by the score on the System Usability scale (SUS)
Description
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
Time Frame
end of intervention( about 4 weeks from baseline)
Title
Usability as assessed by the score on the Presence Questionnaire (PQ)
Description
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.
Time Frame
end of intervention( about 4 weeks from baseline)
Title
Acceptability (ease of use) as assessed by the score on the Simulator Sickness Questionnaire (SSQ) questionnaire
Description
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
Time Frame
Baseline, after each session (3 times a week for 4 weeks about 12 total sessions)
Title
Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA)
Description
Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.
Time Frame
Baseline, end of intervention( about 4 weeks from baseline)
Title
Change in limb function as assessed by the Action Research Arm Test (ARAT)
Description
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.
Time Frame
Baseline, end of intervention( about 4 weeks from baseline)
Title
Change in arm impairment as assessed by Fugl Meyer - Upper Extremity assessment
Description
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.
Time Frame
Baseline, end of intervention( about 4 weeks from baseline)
Title
Change in burden of caregivers in supporting the stroke survivor as assessed by the Burden Scale for Family Caregivers - short version
Description
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
Time Frame
Baseline, end of intervention( about 4 weeks from baseline)
Secondary Outcome Measure Information:
Title
Change in Impact of the rehabilitation on the participant as assessed by the qualitative interview
Time Frame
Baseline, end of intervention (about 4 weeks from baseline)
Title
Change in Impact of the rehabilitation on the caregiver as assessed by the qualitative interview
Time Frame
Baseline, end of intervention( about 4 weeks from baseline)
Title
Number of subjects who have received occupational therapy
Time Frame
Session 1 (week 1 day 1)
Title
Number of subjects who have received occupational therapy
Time Frame
Session 2 (week 1 day 2)
Title
Number of subjects who have received occupational therapy
Time Frame
Session 3 (week 1 day 3)
Title
Number of subjects who have received occupational therapy
Time Frame
Session 4(week 2 day 1)
Title
Number of subjects who have received occupational therapy
Time Frame
Session 5 (week 2 day 2)
Title
Number of subjects who have received occupational therapy
Time Frame
Session 6 (week 2 day 3)
Title
Number of subjects who have received occupational therapy
Time Frame
Session 7 (week 3 day 1)
Title
Number of subjects who have received occupational therapy
Time Frame
Session 8 (week 3 day 2)
Title
Number of subjects who have received occupational therapy
Time Frame
Session 9 (week 3 day 3)
Title
Number of subjects who have received occupational therapy
Time Frame
Session 10 (week 4 day 1)
Title
Number of subjects who have received occupational therapy
Time Frame
Session 11 (week 4 day 2)
Title
Number of subjects who have received occupational therapy
Time Frame
Session 12 (week 4 day3 )
Title
Number of subjects who have received physical therapy
Time Frame
Session 1 (week 1 day 1)
Title
Number of subjects who have received physical therapy
Time Frame
Session 2 (week 1 day 2)
Title
Number of subjects who have received physical therapy
Time Frame
Session 3 (week 1 day 3)
Title
Number of subjects who have received physical therapy
Time Frame
Session 4(week 2 day 1)
Title
Number of subjects who have received physical therapy
Time Frame
Session 5 (week 2 day 2)
Title
Number of subjects who have received physical therapy
Time Frame
Session 6 (week 2 day 3)
Title
Number of subjects who have received physical therapy
Time Frame
Session 7 (week 3 day 1)
Title
Number of subjects who have received physical therapy
Time Frame
Session 8 (week 3 day 2)
Title
Number of subjects who have received physical therapy
Time Frame
Session 9 (week 3 day 3)
Title
Number of subjects who have received physical therapy
Time Frame
Session 10 (week 4 day 1)
Title
Number of subjects who have received physical therapy
Time Frame
Session 11 (week 4 day 2)
Title
Number of subjects who have received physical therapy
Time Frame
Session 12 (week 4 day3 )
Title
Number of subjects who have received speech therapy
Time Frame
Session 1 (week 1 day 1)
Title
Number of subjects who have received speech therapy
Time Frame
Session 2 (week 1 day 2)
Title
Number of subjects who have received speech therapy
Time Frame
Session 3 (week 1 day 3)
Title
Number of subjects who have received speech therapy
Time Frame
Session 4(week 2 day 1)
Title
Number of subjects who have received speech therapy
Time Frame
Session 5 (week 2 day2)
Title
Number of subjects who have received speech therapy
Time Frame
Session 6 (week 2 day 3)
Title
Number of subjects who have received speech therapy
Time Frame
Session 7 (week 3 day 1)
Title
Number of subjects who have received speech therapy
Time Frame
Session 8 (week 3 day 2)
Title
Number of subjects who have received speech therapy
Time Frame
Session 9 (week 3 day 3)
Title
Number of subjects who have received speech therapy
Time Frame
Session 10 (week 4 day 1)
Title
Number of subjects who have received speech therapy
Time Frame
Session 11 (week 4 day 2)
Title
Number of subjects who have received speech therapy
Time Frame
Session 12 (week 4 day 3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seema S Aggarwal, PhD, APRN, AGNP-C
Phone
713-500-9946
Email
Seema.S.Aggarwal@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anna K Hernandez
Phone
713-500-2219
Email
Anna.K.Hernandez@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seema S Aggarwal, PhD, APRN, AGNP-C
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seema S Aggarwal, PhD, APRN, AGNP-C
Phone
713-500-9946
Email
Seema.S.Aggarwal@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Anna K Hernandez
Phone
713-500-9946
Email
Anna.K.Hernandez@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Feasibility, Usability, and Acceptability of Using the Oculus™ Virtual Reality Gaming Technology in Stroke Survivors for Upper Extremity and Cognitive Rehabilitation
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