Study Summary
This trial tests if a virtual reality game can help stroke survivors with arm and cognitive impairments, and the impact it has on caregivers.
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
9 Primary · 7 Secondary · Reporting Duration: Baseline, after each session (3 times a week for 4 weeks about 12 total sessions)
Week 4
Acceptability (ease of use) as assessed by the score on the Simulator Sickness Questionnaire (SSQ) questionnaire
Week 4
Change in Impact of the rehabilitation on the participant as assessed by the qualitative interview
Week 4
Change in Impact of the rehabilitation on the caregiver as assessed by the qualitative interview
Change in arm impairment as assessed by Fugl Meyer - Upper Extremity assessment
Change in burden of caregivers in supporting the stroke survivor as assessed by the Burden Scale for Family Caregivers - short version
Change in cognition as assessed by the Montreal Cognitive Assessment (MoCA)
Change in limb function as assessed by the Action Research Arm Test (ARAT)
Week 4
Number of subjects who have received speech therapy
Week 4
Number of subjects who have received occupational therapy
Number of subjects who have received physical therapy
Week 4
Feasibility as assessed by the number of sessions attended
Feasibility as assessed by the time spent using the Oculus VR
Impact of the rehabilitation on the caregiver as assessed by the qualitative interview
Impact of the rehabilitation on the participant as assessed by the qualitative interview
Usability as assessed by the score on the Presence Questionnaire (PQ)
Usability as assessed by the score on the System Usability scale (SUS)
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
Oculus VR
1 of 1
Experimental Treatment
40 Total Participants · 1 Treatment Group
Primary Treatment: Oculus VR · No Placebo Group · N/A
Oculus VR
Device
Experimental Group · 1 Intervention: Oculus VR · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, after each session (3 times a week for 4 weeks about 12 total sessions)
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
836 Previous Clinical Trials
264,001 Total Patients Enrolled
41 Trials studying Stroke
6,698 Patients Enrolled for Stroke
IoT and Aging in Place Joint Seed GrantUNKNOWN
Seema S Aggarwal, PhD, APRN, AGNP-CPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Eligibility Criteria
Age 18+ · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Texas | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Frequently Asked Questions
Are individuals still invited to participate in this research endeavor?
"According to the clinicaltrials.gov database, this research project is not currently in search of new participants; it was initially posted on September 1st 2023 and last updated December 20th 2022. Despite that, there are 993 other trials with active recruitment at present." - Anonymous Online Contributor
Unverified Answer