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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03784053
Other study ID # 1341686
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 21, 2019
Est. completion date January 14, 2020

Study information

Verified date January 2019
Source University of the Sciences in Philadelphia
Contact Sara Benham, OTD, OTR/L
Phone 317-979-4461
Email s.benham@usciences.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Older adult participants will complete eight immersive virtual reality (VR) sessions with the researcher, within five weeks (no more than two sessions per week may be scheduled). The screening process and assessment measures are not included in the five weeks of virtual reality. Sessions will consist of 30 minutes of use of the virtual reality goggles. During the virtual reality sessions, participants will select from a list of Oculus Go apps related to their self-identified occupational performance issues. Participants are expected to complete the session while seated with the VR set secured on their head.


Description:

Virtual reality (VR) may promote engagement in meaningful daily activities that is tailored to the individual's skill level, need, and significance to their individual context. There is limited research on measurable changes in perceived meaningful daily activities after utilizing immersive VR, specifically with a head mounted display. Only in recent years have head-mounted displays become less expensive and more commercially available for research and patron purchase. At the low cost of $250, the device is within the reach of many older adult community centers for leisure and recreational use. The researchers will measure changes in occupational performance, occupational satisfaction, and quality of life for the older adult members of a community center, after eight immersive VR sessions. Sessions will consist of 30 minutes of use of the virtual reality goggles. During the virtual reality sessions, participants will select from a list of Oculus Go apps related to their self-identified occupational performance issues. Participants are expected to complete the session while seated with the VR set secured on their head.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date January 14, 2020
Est. primary completion date August 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria:

1. Older adults aged 55+ that attend Journey's Way

2. Members need to attend least twice a week

Exclusion Criteria:

1. Score of 17 or less on the MoCA

2. A self-report a history of any of the following: Seizures, epilepsy, dizziness, vertigo, or motion sickness, any current contagious skin and eye conditions, experience sensitivity to light, have or use hearing aids, and a pacemaker and/or a defibrillator.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Immersive virtual reality
At the start of every session, the participants' top five occupational problems will be reviewed, and a list of apps corresponding to the desired occupational problem will be offered through the immersive virtual reality device (Oculus Go). There will be eight 30-minute virtual reality sessions.

Locations

Country Name City State
United States Journey's Way Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of the Sciences in Philadelphia

Country where clinical trial is conducted

United States, 

References & Publications (3)

Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. — View Citation

Law, M., Baptiste, S., Carswell, A., McColl, M., Polatajko, H., & Pollock, N. (2005). Canadian occupational performance measure (4th ed.). Ottawa, Ont.: Canadian Association of Occupational Therapists.

Trzepacz PT, Hochstetler H, Wang S, Walker B, Saykin AJ; Alzheimer’s Disease Neuroimaging Initiative. Relationship between the Montreal Cognitive Assessment and Mini-mental State Examination for assessment of mild cognitive impairment in older adults. BMC Geriatr. 2015 Sep 7;15:107. doi: 10.1186/s12877-015-0103-3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The Canadian Occupational Therapy Performance Measure (COPM) The COPM is a standardized outcome measure that identifies an individual's perceived occupational performance and occupational satisfaction and detects change in these areas over time. Through a semi-structured interview, individuals will identify their difficulties with self-care, leisure, and productivity (Law et al., 2005). The client is asked to rate the importance of each of the occupations to his/her life using a 10-point rating scale (1 to 10). Then, the client will rate the performance and satisfaction of the occupations on a 10-point rating scale (1 to 10). Then, the average performance satisfaction is calculated (1 to 10) and the average satisfaction is calculated (1 to 10). Higher scores indicate better outcomes. 10 minutes
Secondary World Health Organization Quality of Life BREF (WHOQOL-BREF) The WHOQOL-BREF is an assessment used to measure an individual's perceived quality of life. It has 26 items across the following four domains: physical health, psychological health, social relationships, and environment. Items are scored on a scale of 1 to 5 (a higher score is a more favorable outcome). Raw scores are calculated of each domain, and then scores may be transformed to scores ranging from 4 to 20 within each domain. 10 minutes
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