Rehabilitation Exercise of ICU PatientsNCT05522400
Development and Application of Virtual Reality (VR) and Human Computer Interaction System in the ICU Patients
A study testing Virtual Reality (VR) and human computer interaction system in people with Rehabilitation Exercise of ICU Patients, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation Exercise of ICU Patients
- What is being tested?
- Virtual Reality (VR) and human computer interaction system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Voluntary participation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Rehabilitation Exercise of ICU Patients
- Being tested
- Virtual Reality (VR) and human computer interaction system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR) and human computer interaction systemBehavioural
The experimental group used VR technology and human-computer interaction system for exercise, while the control group used traditional exercise program
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Behavioral: Virtual Reality (VR) and human computer interaction system |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of the ICU-acquired asthenia
during ICU stay
Measured: up to 2 weeks
Average daily physical activity time
during ICU stay
Measured: up to 2 weeks
length of ICU stay
during ICU stay
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 May 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rehabilitation Exercise of ICU PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenyan PAN, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522400
- Sponsor's protocol ID
- 2020ZSLC68
- Status last verified
- Aug 2022
- First submitted
- 30 Nov 2021
- Last updated
- 31 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality (VR) and Human Computer Interaction System in the Early Stage of ICU Patients Development and Application of Rehabilitation Exercise
- ClinicalTrials.gov ID
- NCT05522400
- Acronym / sponsor ID
- 2020ZSLC68
- Conditions
- Rehabilitation Exercise of ICU Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Virtual Reality (VR) and human computer interaction system |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
Key exclusion criteria (7 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality (VR) and human computer interaction systemThe experimental group used VR technology and human-computer interaction system for exercise, while the control group used traditional exercise program | Behavioural | intervention group |
Primary outcome
incidence of the ICU-acquired asthenia
Time frame: up to 2 weeks
during ICU stay
Average daily physical activity time
Time frame: up to 2 weeks
during ICU stay
length of ICU stay
Time frame: up to 2 weeks
during ICU stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenyan PAN principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality (VR) and human computer interaction system in people with Rehabilitation Exercise of ICU Patients, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenyan PAN (+8664041990, pan.wenyan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of the ICU-acquired asthenia (time frame: up to 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.