VR for Surgical Prehabilitation and Rehabilitation

NCT ID: NCT06334380

Last Updated: 2024-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Frailty Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants randomized to one of two arms, VR self-paced modules with live PT guidance and VR without live PT guidance.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Blinded assessor will conduct adherence calls.

Study Groups

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Control Group: Virtual Reality Modules Only

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

Group Type ACTIVE_COMPARATOR

Virtual Reality Modules Only

Intervention Type 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.

Intervention Group: Virtual Reality Modules + Live Physical Therapist Support

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.

Group Type EXPERIMENTAL

Virtual Reality Modules + Live Physical Therapist Support

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Cindy Kin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford Hospital and Clinics

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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73688

Identifier Type: -

Identifier Source: org_study_id

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