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
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Frailty
• Surgery

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