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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05672628
• Other study ID #: HSC-SN-22-0838
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Seema S Aggarwal, PhD, APRN, AGNP-C
• Phone: 713-500-9946
• Email: Seema.S.Aggarwal[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)	end of intervention( about 4 weeks from baseline)
Primary	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	end of intervention( about 4 weeks from baseline)
Primary	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.	end of intervention( about 4 weeks from baseline)
Primary	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	Baseline, after each session (3 times a week for 4 weeks about 12 total sessions)
Primary	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.	Baseline, end of intervention( about 4 weeks from baseline)
Primary	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.	Baseline, end of intervention( about 4 weeks from baseline)
Primary	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.	Baseline, end of intervention( about 4 weeks from baseline)
Primary	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	Baseline, end of intervention( about 4 weeks from baseline)
Secondary	Change in Impact of the rehabilitation on the participant as assessed by the qualitative interview		Baseline, end of intervention (about 4 weeks from baseline)
Secondary	Change in Impact of the rehabilitation on the caregiver as assessed by the qualitative interview		Baseline, end of intervention( about 4 weeks from baseline)
Secondary	Number of subjects who have received occupational therapy		Session 1 (week 1 day 1)
Secondary	Number of subjects who have received occupational therapy		Session 2 (week 1 day 2)
Secondary	Number of subjects who have received occupational therapy		Session 3 (week 1 day 3)
Secondary	Number of subjects who have received occupational therapy		Session 4(week 2 day 1)
Secondary	Number of subjects who have received occupational therapy		Session 5 (week 2 day 2)
Secondary	Number of subjects who have received occupational therapy		Session 6 (week 2 day 3)
Secondary	Number of subjects who have received occupational therapy		Session 7 (week 3 day 1)
Secondary	Number of subjects who have received occupational therapy		Session 8 (week 3 day 2)
Secondary	Number of subjects who have received occupational therapy		Session 9 (week 3 day 3)
Secondary	Number of subjects who have received occupational therapy		Session 10 (week 4 day 1)
Secondary	Number of subjects who have received occupational therapy		Session 11 (week 4 day 2)
Secondary	Number of subjects who have received occupational therapy		Session 12 (week 4 day3 )
Secondary	Number of subjects who have received physical therapy		Session 1 (week 1 day 1)
Secondary	Number of subjects who have received physical therapy		Session 2 (week 1 day 2)
Secondary	Number of subjects who have received physical therapy		Session 3 (week 1 day 3)
Secondary	Number of subjects who have received physical therapy		Session 4(week 2 day 1)
Secondary	Number of subjects who have received physical therapy		Session 5 (week 2 day 2)
Secondary	Number of subjects who have received physical therapy		Session 6 (week 2 day 3)
Secondary	Number of subjects who have received physical therapy		Session 7 (week 3 day 1)
Secondary	Number of subjects who have received physical therapy		Session 8 (week 3 day 2)
Secondary	Number of subjects who have received physical therapy		Session 9 (week 3 day 3)
Secondary	Number of subjects who have received physical therapy		Session 10 (week 4 day 1)
Secondary	Number of subjects who have received physical therapy		Session 11 (week 4 day 2)
Secondary	Number of subjects who have received physical therapy		Session 12 (week 4 day3 )
Secondary	Number of subjects who have received speech therapy		Session 1 (week 1 day 1)
Secondary	Number of subjects who have received speech therapy		Session 2 (week 1 day 2)
Secondary	Number of subjects who have received speech therapy		Session 3 (week 1 day 3)
Secondary	Number of subjects who have received speech therapy		Session 4(week 2 day 1)
Secondary	Number of subjects who have received speech therapy		Session 5 (week 2 day2)
Secondary	Number of subjects who have received speech therapy		Session 6 (week 2 day 3)
Secondary	Number of subjects who have received speech therapy		Session 7 (week 3 day 1)
Secondary	Number of subjects who have received speech therapy		Session 8 (week 3 day 2)
Secondary	Number of subjects who have received speech therapy		Session 9 (week 3 day 3)
Secondary	Number of subjects who have received speech therapy		Session 10 (week 4 day 1)
Secondary	Number of subjects who have received speech therapy		Session 11 (week 4 day 2)
Secondary	Number of subjects who have received speech therapy		Session 12 (week 4 day 3)