The Usability, Feasibility, and Tolerability of Virtual Reality for Rehabilitation From COVID-19

NCT ID: NCT04505761

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-03-31

Brief Summary

Patients who receive intensive care are known to be at high risk for physical, psychological, and cognitive impairments, a constellation known as PICS. COVID-19 patients are expected to have high chances of suffering from PICS (PICS-COV) as they frequently require several weeks of intensive care and traditional PICS preventive measures are virtually impossible due to infection control precautions, prone positioning, and deprivation of social contact. To prevent PICS after ICU discharge in COVID-19 patients, physical therapy is recommended. From recent but limited experience it appears that even patients with COVID-19 who have not been admitted to the ICU can suffer from impairments in the same domains and sometimes to a similar degree of severity. Also for these patient group rehabilitation seems warranted.

Yet, the resources needed to provide rehabilitation treatment to COVID-19 patients are inadequate because healthcare systems faced a shortage of high-quality treatment for these impairments already before the COVID-19 crisis emerged. Virtual Reality (VR) provides potential to healthcare practitioners to administer fast, temporary, and tailor-made rehabilitation services at a distance, and offers a solution to address the impending surge of demand for rehabilitation after COVID-19 infection. VR consists of a head mounted display (HMD) that can bring the user by computer-generated visuals into an immersive, realistic multi-sensory environment. Current VR technology is accessible, easy in use for a large audience, and safe in use. There already exist multiple VR applications for providing physical, psychological, and cognitive rehabilitation. These applications have been brought together in a VR suite for rehabilitation after COVID-19. Patients visiting a physiotherapist for rehabilitation from COVID-19 will be asked to participate in this study. They receive a VR HMD for training purposes. This study aims to understand the usability, feasibility, and tolerability of VR for rehabilitation after COVID-19, and to pilot the effectiveness of VR improving the physical ability, mental and cognitive status of patients.

Conditions

Coronavirus; Post Intensive Care Unit Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Participants will receive Virtual Reality as an add-on to standard physiotherapy after COVID-19.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

Participants will use a Virtual Reality headset with a range of applications applicable for rehabilitation after COVID-19. Applications target physical, psychological, and cognitive rehabilitation. VR headset will be used for six weeks first at the physiotherapist's practice, and when possible, at home.

Interventions

Virtual Reality

Participants will use a Virtual Reality headset with a range of applications applicable for rehabilitation after COVID-19. Applications target physical, psychological, and cognitive rehabilitation. VR headset will be used for six weeks first at the physiotherapist's practice, and when possible, at home.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient has had COVID-19.

2. Patient has an indication for physical therapy in the context of rehabilitation after COVID-19.

3. At the day of recruitment, the estimated length of the physical therapy is at least 3 weeks after inclusion.

4. Patient is willing and able to comply with the study protocol.

5. Patient is at least 16 years old on the day the informed consent form will be signed.

6. Patient can read and understand the Dutch language.

Exclusion Criteria

1. The patient is participating in another study interfering with this study.

2. Patient has difficulties to handle virtual reality:

1. Patient suffers from delirium or acute confusional state.

2. Patient has (a history of) dementia, seizure, or epilepsy.

3. Patient has severe hearing/visual impairment not corrected.

4. The skin of the patient's head or face is not intact (for example head wounds, psoriasis, eczema).

3. Patient has a high risk of contamination with a therapy resistant micro-organism e.g. MRSA.

4. Patients suffers from severe anxiety or depression (HADS≥16).

5. Red flags (see Appendix 1).

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harry van Goor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Bart Staal, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboud university medical center

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

References

Groenveld T, Achttien R, Smits M, de Vries M, van Heerde R, Staal B, van Goor H; COVID Rehab Group. Feasibility of Virtual Reality Exercises at Home for Post-COVID-19 Condition: Cohort Study. JMIR Rehabil Assist Technol. 2022 Aug 15;9(3):e36836. doi: 10.2196/36836.

Reference Type: DERIVED

PMID: 35858254 (View on PubMed)

Other Identifiers

COVRehab

Identifier Type: -

Identifier Source: org_study_id