Clinical trial NCT04505761: The Usability, Feasibility, and Tolerability of Virtual Reality for Rehabilitation From COVID-19
Official title: The Usability, Feasibility, and Tolerability of Virtual Reality for Rehabilitation From COVID-19: An Explorative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus
Post Intensive Care Unit Syndrome
Keywords: Virtual Reality
Rehabilitation
Post-intensive care syndrome
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 48
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants are asked to use Virtual Reality as an add-on to standard physiotherapy for revalidation after COVID-19.
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Semi-structured interview with 15 patients on their experiences of VR for rehabilitation from COVID-19.
timeFrame: Day 42
measure: Use of VR
timeFrame: Day 42
measure: Semi-structured interviews with physiotherapists on their experiences of VR for rehabilitation from COVID-19.
timeFrame: Day 42
Secondary outcomes:
measure: Change in baseline performance test (guidelines KNGF) - Patient specific complaints.
timeFrame: Day 0, day 42
measure: Change in baseline performance test (guidelines KNGF) - 6 minute walk test
timeFrame: Day 0, Day 42
measure: Change in baseline performance test (guidelines KNGF) - one-repetition maximum test
timeFrame: Day 0, Day 42
measure: Change in baseline performance test (guidelines KNGF) - 30 sec sit to stand
timeFrame: Day 0, Day 42
measure: Change in baseline performance test (guidelines KNGF) - Borgscale for fatigue
timeFrame: Day 0, Day 42
measure: Change in activities of daily life.
timeFrame: Day 0, Day 42
measure: Change in HADS.
timeFrame: Day 0, Day 42
measure: Change in CFQ.
timeFrame: Day 0, Day 42
measure: Change in SF12.
timeFrame: Day 0, Day 42
measure: Change in positive health.
timeFrame: Day 0, Day 42
Other outcomes:
measure: Patient characteristics related to use of VR
timeFrame: Day 0
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Harry van Goor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Bart Staal, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.