Development and Application of Virtual Reality (VR) and H... | NCT05522400

Studies
Development and Application of Virtual Reality (VR) and Human Computer Interaction System in the ICU Patients

NCT05522400

Sponsor

Shanghai Zhongshan Hospital

Status

Unknown status

Last Update Posted

Aug 31, 2022Actual

Enrollment

244Estimated

Phase

Not Applicable

Conditions

Rehabilitation Exercise of ICU Patients

Interventions

Virtual Reality (VR) and human computer interaction system

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2021Actual

Primary Completion Date

Sep 1, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Nov 30, 2021

First Submission Date that Met QC Criteria

Aug 30, 2022

First Posted Date

Aug 31, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2022

Last Update Posted Date

Aug 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

244Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention group	Experimental		Behavioral: Virtual Reality (VR) and human computer interaction system
control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual Reality (VR) and human computer interaction system	Behavioral	The experimental group used VR technology and human-computer interaction system for exercise, while the control group used traditional exercise program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wenyan PAN	Contact	+8664041990		pan.wenyan@zs-hospital.sh.cn

Overall Officials

Name	Affiliation	Role
Wenyan PAN	Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
180 Fenglin Road	Recruiting	Shanghai		200032	China