Clinical trial NCT05672628: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: rehabilitation
upper limb
stroke survivor
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: IoT and Aging in Place Joint Seed Grant
First posted: 2023-01-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Feasibility as assessed by the number of sessions attended
timeFrame: end of intervention( about 4 weeks from baseline)
measure: Feasibility as assessed by the time spent using the Oculus VR
timeFrame: end of intervention( about 4 weeks from baseline)
measure: Usability as assessed by the score on the System Usability scale (SUS)
timeFrame: end of intervention( about 4 weeks from baseline)
measure: Usability as assessed by the score on the Presence Questionnaire (PQ)
timeFrame: end of intervention( about 4 weeks from baseline)
measure: Acceptability (ease of use) as assessed by the score on the Simulator Sickness Questionnaire (SSQ) questionnaire
timeFrame: Baseline, after each session (3 times a week for 4 weeks about 12 total sessions)
measure: Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, end of intervention( about 4 weeks from baseline)
measure: Change in limb function as assessed by the Action Research Arm Test (ARAT)
timeFrame: Baseline, end of intervention( about 4 weeks from baseline)
measure: Change in arm impairment as assessed by Fugl Meyer - Upper Extremity assessment
timeFrame: Baseline, end of intervention( about 4 weeks from baseline)
measure: Change in burden of caregivers in supporting the stroke survivor as assessed by the Burden Scale for Family Caregivers - short version
timeFrame: Baseline, end of intervention( about 4 weeks from baseline)
Secondary outcomes:
measure: Change in Impact of the rehabilitation on the participant as assessed by the qualitative interview
timeFrame: Baseline, end of intervention (about 4 weeks from baseline)
measure: Change in Impact of the rehabilitation on the caregiver as assessed by the qualitative interview
timeFrame: Baseline, end of intervention( about 4 weeks from baseline)
measure: Number of subjects who have received occupational therapy
timeFrame: Session 1 (week 1 day 1)
measure: Number of subjects who have received occupational therapy
timeFrame: Session 2 (week 1 day 2)
measure: Number of subjects who have received occupational therapy
timeFrame: Session 3 (week 1 day 3)
measure: Number of subjects who have received occupational therapy
timeFrame: Session 4(week 2 day 1)
measure: Number of subjects who have received occupational therapy
timeFrame: Session 5 (week 2 day 2)
measure: Number of subjects who have received occupational therapy
timeFrame: Session 6 (week 2 day 3)
measure: Number of subjects who have received occupational therapy
timeFrame: Session 7 (week 3 day 1)
measure: Number of subjects who have received occupational therapy
timeFrame: Session 8 (week 3 day 2)
measure: Number of subjects who have received occupational therapy
timeFrame: Session 9 (week 3 day 3)
measure: Number of subjects who have received occupational therapy
timeFrame: Session 10 (week 4 day 1)
measure: Number of subjects who have received occupational therapy
timeFrame: Session 11 (week 4 day 2)
measure: Number of subjects who have received occupational therapy
timeFrame: Session 12 (week 4 day3 )
measure: Number of subjects who have received physical therapy
timeFrame: Session 1 (week 1 day 1)
measure: Number of subjects who have received physical therapy
timeFrame: Session 2 (week 1 day 2)
measure: Number of subjects who have received physical therapy
timeFrame: Session 3 (week 1 day 3)
measure: Number of subjects who have received physical therapy
timeFrame: Session 4(week 2 day 1)
measure: Number of subjects who have received physical therapy
timeFrame: Session 5 (week 2 day 2)
measure: Number of subjects who have received physical therapy
timeFrame: Session 6 (week 2 day 3)
measure: Number of subjects who have received physical therapy
timeFrame: Session 7 (week 3 day 1)
measure: Number of subjects who have received physical therapy
timeFrame: Session 8 (week 3 day 2)
measure: Number of subjects who have received physical therapy
timeFrame: Session 9 (week 3 day 3)
measure: Number of subjects who have received physical therapy
timeFrame: Session 10 (week 4 day 1)
measure: Number of subjects who have received physical therapy
timeFrame: Session 11 (week 4 day 2)
measure: Number of subjects who have received physical therapy
timeFrame: Session 12 (week 4 day3 )
measure: Number of subjects who have received speech therapy
timeFrame: Session 1 (week 1 day 1)
measure: Number of subjects who have received speech therapy
timeFrame: Session 2 (week 1 day 2)
measure: Number of subjects who have received speech therapy
timeFrame: Session 3 (week 1 day 3)
measure: Number of subjects who have received speech therapy
timeFrame: Session 4(week 2 day 1)
measure: Number of subjects who have received speech therapy
timeFrame: Session 5 (week 2 day2)
measure: Number of subjects who have received speech therapy
timeFrame: Session 6 (week 2 day 3)
measure: Number of subjects who have received speech therapy
timeFrame: Session 7 (week 3 day 1)
measure: Number of subjects who have received speech therapy
timeFrame: Session 8 (week 3 day 2)
measure: Number of subjects who have received speech therapy
timeFrame: Session 9 (week 3 day 3)
measure: Number of subjects who have received speech therapy
timeFrame: Session 10 (week 4 day 1)
measure: Number of subjects who have received speech therapy
timeFrame: Session 11 (week 4 day 2)
measure: Number of subjects who have received speech therapy
timeFrame: Session 12 (week 4 day 3)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Seema S Aggarwal, PhD, APRN, AGNP-C
role: PRINCIPAL_INVESTIGATOR
References: