- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05522400
Development and Application of Virtual Reality (VR) and Human Computer Interaction System in the ICU Patients
August 30, 2022 updated by: Shanghai Zhongshan Hospital
Virtual Reality (VR) and Human Computer Interaction System in the Early Stage of ICU Patients Development and Application of Rehabilitation Exercise
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
244
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wenyan PAN
- Phone Number: +8664041990
- Email: pan.wenyan@zs-hospital.sh.cn
Study Locations
-
-
-
Shanghai, China, 200032
- Recruiting
- 180 Fenglin Road
-
Contact:
- Wenyan PAN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Over 18 years of age
- Voluntary participation
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
|
|
Experimental: intervention group
|
The experimental group used VR technology and human-computer interaction system for exercise, while the control group used traditional exercise program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of the ICU-acquired asthenia
Time Frame: up to 2 weeks
|
during ICU stay
|
up to 2 weeks
|
Average daily physical activity time
Time Frame: up to 2 weeks
|
during ICU stay
|
up to 2 weeks
|
length of ICU stay
Time Frame: up to 2 weeks
|
during ICU stay
|
up to 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wenyan PAN, Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2021
Primary Completion (Anticipated)
September 1, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
November 30, 2021
First Submitted That Met QC Criteria
August 30, 2022
First Posted (Actual)
August 31, 2022
Study Record Updates
Last Update Posted (Actual)
August 31, 2022
Last Update Submitted That Met QC Criteria
August 30, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 2020ZSLC68
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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