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Trial Title:
VR for Surgical Prehabilitation and Rehabilitation
NCT ID:
NCT06334380
Condition:
Breast Cancer
Frailty
Surgery
Conditions: Official terms:
Frailty
Conditions: Keywords:
Prehabilitation
Rehabilitation
Virtual Reality
Physical Therapy
Breast Surgery
Breast Cancer
Breast Reconstruction
Axillary Surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Participants randomized to one of two arms, VR self-paced modules with live PT guidance
and VR without live PT guidance.
Primary purpose:
Other
Masking:
Single (Outcomes Assessor)
Masking description:
Blinded assessor will conduct adherence calls.
Intervention:
Intervention type:
Other
Intervention name:
Virtual Reality Modules Only
Description:
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.
Arm group label:
Control Group: Virtual Reality Modules Only
Intervention type:
Other
Intervention name:
Virtual Reality Modules + Live Physical Therapist Support
Description:
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.
Arm group label:
Intervention Group: Virtual Reality Modules + Live Physical Therapist Support
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford Hospital and Clinics
Address:
City:
Palo Alto
Zip:
94305
Country:
United States
Start date:
April 15, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Stanford University
Agency class:
Other
Source:
Stanford University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06334380