NCT05522400

Brief Summary

By developing of VR and human computer interaction system of early rehabilitation exercise for ICU patients, this project aims to construct virtual scenes and realize the interaction between ICU patients and virtual scenes during active rehabilitation training for critically ill patients in long-term bed. This project can increase the patient's willingness to exercise rehabilitation, improve the training effect and improve clinical outcomes in critically ill patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2021

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

November 30, 2021

Last Update Submit

August 30, 2022

Conditions

Rehabilitation Exercise of ICU Patients

Outcome Measures

Primary Outcomes (3)

  • incidence of the ICU-acquired asthenia

    during ICU stay

    up to 2 weeks

  • Average daily physical activity time

    during ICU stay

    up to 2 weeks

  • length of ICU stay

    during ICU stay

    up to 2 weeks

Study Arms (2)

intervention group

EXPERIMENTAL
Behavioral: Virtual Reality (VR) and human computer interaction system

control group

NO INTERVENTION

Interventions

Virtual Reality (VR) and human computer interaction systemBEHAVIORAL

The experimental group used VR technology and human-computer interaction system for exercise, while the control group used traditional exercise program

intervention group

Eligibility Criteria

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

You may qualify if:

  • Over 18 years of age
  • Voluntary participation

You may not qualify if:

  • Unable to walk independently before admission to ICU;
  • High dose of vasoactive drugs to maintain vital signs;
  • Acute stroke;
  • Upper limb fractures or amputations;
  • Patients with spinal fracture or pathological fracture;
  • Patients who have been hospitalized for 30 days or more before admission to ICU;
  • Plan to move out of ICU within 24 hours; In palliative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, 200032, China

RECRUITING

Study Officials

  • Wenyan PAN

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenyan PAN

CONTACT

+8664041990pan.wenyan@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2021

First Posted

August 31, 2022

Study Start

May 1, 2021

Primary Completion

September 1, 2023

Study Completion

December 31, 2023

Last Updated

August 31, 2022

Record last verified: 2022-08

Locations

CN(1)