NCT07234201

Brief Summary

The purpose of this study is to explore if Virtual Reality (VR) helps patients in the Intensive Care Unit (ICU) move more and feel better.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Dec 2025Nov 2027

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

November 14, 2025

Last Update Submit

January 8, 2026

Conditions

Intensive Care Unit ICU

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Increased Mobility

    10 days or ICU discharge, which ever comes first

Secondary Outcomes (1)

  • Number of participants with Improved psychosocial well-being

    10 days or ICU discharge, which ever comes first

Study Arms (2)

Control

NO INTERVENTION

Standard mobility care

VR intervention

OTHER

Virtual Reality

Other: Nurse driven virtual reality mobility session

Interventions

Nurse driven virtual reality mobility sessionOTHER

Participants will use the virtual reality device to play the game that will facilitate movement of arms, shoulders and trunk to music, similar to dancing or Tai-Chi.

VR intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking
  • Adults age 18 or greater
  • ICU stay greater or equal to 3 days
  • Limited mobility

You may not qualify if:

  • Pregnancy
  • Special enteric contact isolation
  • Blindness
  • History of seizure or vertigo
  • Intubated and sedated
  • ICU delirium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

RECRUITING

Study Officials

  • Anna Mall

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Mall

CONTACT

984-227-0106anna.mall@duke.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)