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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

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