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

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05672628
Collaborator
IoT and Aging in Place Joint Seed Grant (Other)
40
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1
3
13.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Oculus VR
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Feasibility, Usability, and Acceptability of Using the Oculus™ Virtual Reality Gaming Technology in Stroke Survivors for Upper Extremity and Cognitive Rehabilitation
Anticipated Study Start Date :
Jan 9, 2023
Anticipated Primary Completion Date :
Apr 3, 2023
Anticipated Study Completion Date :
Apr 11, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Oculus VR

Device: Oculus VR
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.

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. 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)

  3. 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

  4. 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.

  5. 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

Secondary Outcome Measures

  1. Impact of the rehabilitation on the participant as assessed by the qualitative interview [end of intervention( about 4 weeks from baseline)]

  2. Impact of the rehabilitation on the caregiver as assessed by the qualitative interview [end of intervention( about 4 weeks from baseline)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  • score ranges that indicate mild to moderate severity on the Montreal Cognitive Assessment (MoCA )(15-25), 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Seema S Aggarwal, PhD, APRN, AGNP-C, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seema S Aggarwal, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT05672628
Other Study ID Numbers:
  • HSC-SN-22-0838
First Posted:
Jan 5, 2023
Last Update Posted:
Jan 5, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Seema S Aggarwal, Assistant Professor, The University of Texas Health Science Center, Houston
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 5, 2023