VR for Surgical Prehabilitation and Rehabilitation

NCT06334380 | Enrolling By Invitation

• 1 other identifier: 73688
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Frailty; Surgery

Keywords

Prehabilitation; Rehabilitation; Virtual Reality; Physical Therapy; Breast Surgery; Breast Cancer; Breast Reconstruction; Axillary Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Group: Virtual Reality Modules Only

ACTIVE COMPARATOR

Participants will have access to the prehabilitation (preoperative) and rehabilitation (postoperative) virtual reality physical therapy modules.

Other: Virtual Reality Modules Only

Intervention Group: Virtual Reality Modules + Live Physical Therapist Support

EXPERIMENTAL

Participants will have access to prehabilitation and rehabilitation virtual reality physical therapy modules in addition to zoom "office hours" with the physical therapist so that they may ask questions.

Other: Virtual Reality Modules + Live Physical Therapist Support

Interventions

Virtual Reality Modules Only OTHER

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.

Control Group: Virtual Reality Modules Only

Virtual Reality Modules + Live Physical Therapist Support OTHER

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.

Intervention Group: Virtual Reality Modules + Live Physical Therapist Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Frailty

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessor will conduct adherence calls.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants randomized to one of two arms, VR self-paced modules with live PT guidance and VR without live PT guidance.

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 28, 2024
• Study Start: April 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)