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NCT06334380 Clinical Trial

VR for Surgical Prehabilitation and Rehabilitation

Breast Cancer Clinical Trial

— VR-PREP  

Official title:
Virtual Reality for Surgical Prehabilitation and Rehabilitation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06334380
Other study ID # 73688
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 15, 2024
Est. completion date December 31, 2024

Study information
Verified date April 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized controlled trial aims to determine feasibility and acceptability of of VR-physical therapy modules for surgical patients undergoing breast or axilla surgery in order to prepare for and recover from surgery.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 30
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18+ years of age - English speaking - Will undergo breast or axilla surgery at Stanford - Have access to internet and stable Wifi at home - Have access to a space with stable chair at home - Ability to sit-to-stand without significant balance issues - Absence of chronic vertigo or nausea/vomiting - Agreeable to up to 4 weeks of prehab prior to surgery and up to 8 weeks of post-operative rehab Exclusion Criteria: - Inability to engage in PT due to physical limitations identified by the participant and/or care team - Inability to complete a brief online survey at three time points during the duration of the study - Inability to consent

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Virtual Reality Modules Only
Participants will complete self-paced VR modules prior to and after surgery (prehab/rehab) and will be provided with technical assistance from the study team.
• Virtual Reality Modules + Live Physical Therapist Support
Participants will complete self-paced VR modules prior to and after surgery (prehab/rehab) and will be provided with technical assistance from the study team. Participants will also have access to up to three live PT sessions via Zoom where they can ask questions and complete modules with PT feedback.

Locations
Country Name City State
United States Stanford Hospital and Clinics Palo Alto California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary VR for remote Physical Therapy (PT) This study will evaluate the feasibility of using VR technology to perform PT remotely from patients' homes to prepare for and recover from surgery. Frequency of engagement with the VR system (e.g., number of times participant initiated a VR physical therapy module, how long each session was used for) will be measured. Engagement with the live PT sessions will be measured. 12 weeks
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