CoronavirusCOVRehabNCT04505761
The Usability, Feasibility, and Tolerability of Virtual Reality for Rehabilitation From COVID-19
A study testing Virtual Reality in people with Coronavirus and Post Intensive Care Unit Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Coronavirus, Post Intensive Care Unit Syndrome
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2020to 31 Mar 2021
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient has had COVID-19.
- Patient has an indication for physical therapy in the context of rehabilitation after COVID-19.
- At the day of recruitment, the estimated length of the physical therapy is at least 3 weeks after inclusion.
- Patient is willing and able to comply with the study protocol.
- Patient is at least 16 years old on the day the informed consent form will be signed.
- Patient can read and understand the Dutch language.
Who cannot join
- The patient is participating in another study interfering with this study.
- Patient has difficulties to handle virtual reality:
- Patient suffers from delirium or acute confusional state.
- Patient has (a history of) dementia, seizure, or epilepsy.
- Patient has severe hearing/visual impairment not corrected.
- The skin of the patient's head or face is not intact (for example head wounds, psoriasis, eczema).
Show all 9Show fewer
- Patient has a high risk of contamination with a therapy resistant micro-organism e.g. MRSA.
- Patients suffers from severe anxiety or depression (HADS≥16).
- Red flags (see Appendix 1).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6525 GA
About this study
Official title: The Usability, Feasibility, and Tolerability of Virtual Reality for Rehabilitation From COVID-19: An Explorative Study
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
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Rehabilitation, Post-intensive care syndrome
- Medical subject headings
- Coronavirus Infections, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will receive Virtual Reality as an add-on to standard physiotherapy after COVID-19. Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-structured interview with 15 patients on their experiences of VR for rehabilitation from COVID-19.
At the end of the study, 15 patients will be interviewed about their experiences using VR for rehabilitation from COVID-19. The interview will be semi-structured, including questions on usability, tolerability and efficacy of VR according to the patients. The interviews will be recorded, written out and coded by means of grounded theory analysis in Atlas.ti. Themes and subthemes will be constructed.
Measured: Day 42
Use of VR
By means of digital tracking in the VR goggles, we aim to understand what games are used most often by the participants.
Measured: Day 42
Semi-structured interviews with physiotherapists on their experiences of VR for rehabilitation from COVID-19.
At the end of the study, 10 physiotherapists will be interviewed about their experiences using VR for rehabilitation from COVID-19. The interview will be semi-structured, including questions on usability, tolerability and efficacy of VR according to the physiotherapists. The interviews will be recorded, written out and coded by means of grounded theory analysis in Atlas.ti. Themes and subthemes will be constructed.
Measured: Day 42
Secondary outcomes (10)
Change in baseline performance test (guidelines KNGF) - Patient specific complaints.
To investigate whether adding VR to rehabilitation (perceivably) improves physical performance, we use a baseline performance test as constructed by the COVID-19 recommendations (RL 2.0) as issued by the Royal Dutch Society for Physical Therapy (KNGF). Measurements will be done at the start of the intervention period and the end of the intervention period for tracking progress.
The baseline performance test consists of several items of which the patient specific complaints is the first.
Patient specific complaints refer to complaints the patients aim to improve by means of physiotherapy. Outcomes are qualitative outcomes.
Measured: Day 0, day 42
Change in baseline performance test (guidelines KNGF) - 6 minute walk test
To investigate whether adding VR to rehabilitation (perceivably) improves physical performance, we use a baseline performance test as constructed by the COVID-19 recommendations (RL 2.0) as issued by the Royal Dutch Society for Physical Therapy (KNGF). Measurements will be done at the start of the intervention period and the end of the intervention period for tracking progress.
The baseline performance test consists of several items of which the 6 minute walk test is the second.
The 6 minute walk test studies the physical capacity of a patient. We measure at day 0 how many meter a patient can walk in 6 minutes and compare this to the meters a patient is able to walk at day 42.
Measured: Day 0, Day 42
Change in baseline performance test (guidelines KNGF) - one-repetition maximum test
To investigate whether adding VR to rehabilitation (perceivably) improves physical performance, we use a baseline performance test as constructed by the COVID-19 recommendations (RL 2.0) as issued by the Royal Dutch Society for Physical Therapy (KNGF). Measurements will be done at the start of the intervention period and the end of the intervention period for tracking progress.
The baseline performance test consists of several items of which hand grip strength is the third.
The hand grip strength is measured by the One-repetition maximum test which measures the amount of kg's a patient can grip at his peakforce. Measurements are done at day 0 and day 42 and compared.
Measured: Day 0, Day 42
Change in baseline performance test (guidelines KNGF) - 30 sec sit to stand
To investigate whether adding VR to rehabilitation (perceivably) improves physical performance, we use a baseline performance test as constructed by the COVID-19 recommendations (RL 2.0) as issued by the Royal Dutch Society for Physical Therapy (KNGF). Measurements will be done at the start of the intervention period and the end of the intervention period for tracking progress.
The baseline performance test consists of several items of which the 30 sec sit to stand test for lower extremities is the fourth.
The 30 seconds sit to stand test is for testing leg strength and endurance. A patient has to do as many sit to stand exercises in 30 seconds. Measurements are done at day 0 and compared to day 42.
Measured: Day 0, Day 42
Change in baseline performance test (guidelines KNGF) - Borgscale for fatigue
To investigate whether adding VR to rehabilitation (perceivably) improves physical performance, we use a baseline performance test as constructed by the COVID-19 recommendations (RL 2.0) as issued by the Royal Dutch Society for Physical Therapy (KNGF). Measurements will be done at the start of the intervention period and the end of the intervention period for tracking progress.
The baseline performance test consists of several items of which the Borgscale for fatigue is the final item.
The borgscale for fatigue is a numerical scale (1-10) to rate physical exertion and fatigue. Patients fill in the scale at day 0 and day 42. Results are compared.
Measured: Day 0, Day 42
Change in activities of daily life.
To investigate whether adding VR to rehabilitation (perceivably) improves physical performance, we will as well measure change in activities of Daily Life. This questionnaire (ADL) measures the ease of participating in activities of daily life (ADL) of the patient. The questionnaire consists of 22 questions ranging from 0 (not at all) to 3 (easily autonomous). Maximum score is 63.
Measured: Day 0, Day 42
Change in HADS.
To investigate whether adding VR to rehabilitation (perceivably) improves psychological rehabilitation, we will measure change in HADS. The HADS (Hospital Anxiety and Depression Scale) is used to measure change in psychological outcomes before and after the intervention period. Questionnaire consists out of 14 questions with answers ranging from 0 (often) to 3 (almost never). All questions are summed up to a total of 42 points.
Measured: Day 0, Day 42
Change in CFQ.
To investigate whether adding VR to rehabilitation (perceivably) improves cognitive rehabilitation, we will use the CFQ. The CFQ (Cognitive Failure Questionnaire) is used to measure change in cognitive outcomes before and after the intervention period. Questionnaire consists out 25 questions ranging from 0 to 5. All questions are summed up to a total of 100 points.
Measured: Day 0, Day 42
Change in SF12.
To investigate whether adding VR to rehabilitation (perceivably) improves quality of life, we will use the SF12. The SF12 questionnaire is used to measure change in quality of life before and after the intervention period.
SF12: SF12 measures via different scaled questions eight concepts: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. The first four items together form the physical health scale. The latter four items form the mental health scale. The higher the scores, the better the physical and mental health. Highest possible score: 56. Lowest possible score: 12.
Measured: Day 0, Day 42
Change in positive health.
To investigate whether adding VR to rehabilitation (perceivably) improves quality of life, we will as well use the Positive Health questionnaire. The Positive Health questionnaire is used to measure change in quality of life before and after the intervention period.
Positive Health:Positive health consists out of 42 statements separated in 6 categories: bodily functioning, mental functioning, spiritual dimension, quality of life, social participation, daily functioning. Each question should be rated with a 0 (worst) to a 10 (best). The higher the scores, the better the quality of life.
Measured: Day 0, Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Aug 2020
- Primary completion1 Feb 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants are asked to use Virtual Reality as an add-on to standard physiotherapy for revalidation after COVID-19.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harry van Goor, MD, PhD, Principal investigator, Radboud University Medical CenterBart Staal, PT, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505761
- Sponsor's protocol ID
- COVRehab
- Acronym
- COVRehab
- Status last verified
- Jun 2020
- First submitted
- 3 Jul 2020
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only upon asking.
Publications
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.
PubMed 35858254
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usability, Feasibility, and Tolerability of Virtual Reality for Rehabilitation From COVID-19: An Explorative Study
- ClinicalTrials.gov ID
- NCT04505761
- Acronym / sponsor ID
- COVRehab / COVRehab
- Conditions
- Coronavirus, Post Intensive Care Unit Syndrome
- Keywords
- Virtual Reality, Rehabilitation, Post-intensive care syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 10 Aug 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants are asked to use Virtual Reality as an add-on to standard physiotherapy for revalidation after COVID-19.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Virtual RealityParticipants will receive Virtual Reality as an add-on to standard physiotherapy after COVID-19. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patient has had COVID-19.
- Patient has an indication for physical therapy in the context of rehabilitation after COVID-19.
- At the day of recruitment, the estimated length of the physical therapy is at least 3 weeks after inclusion.
- Patient is willing and able to comply with the study protocol.
- Patient is at least 16 years old on the day the informed consent form will be signed.
Key exclusion criteria (9 listed)
- The patient is participating in another study interfering with this study.
- Patient has difficulties to handle virtual reality:
- Patient has a high risk of contamination with a therapy resistant micro-organism e.g. MRSA.
- Patients suffers from severe anxiety or depression (HADS≥16).
- Red flags (see Appendix 1).
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 RealityParticipants 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. | Device | Intervention group |
Primary outcome
Semi-structured interview with 15 patients on their experiences of VR for rehabilitation from COVID-19.
Time frame: Day 42
At the end of the study, 15 patients will be interviewed about their experiences using VR for rehabilitation from COVID-19. The interview will be semi-structured, including questions on usability, tolerability and efficacy of VR according to the patients. The interviews will be recorded, written out and coded by means of grounded theory analysis in Atlas.ti. Themes and subthemes will be constructed.
Use of VR
Time frame: Day 42
By means of digital tracking in the VR goggles, we aim to understand what games are used most often by the participants.
Semi-structured interviews with physiotherapists on their experiences of VR for rehabilitation from COVID-19.
Time frame: Day 42
At the end of the study, 10 physiotherapists will be interviewed about their experiences using VR for rehabilitation from COVID-19. The interview will be semi-structured, including questions on usability, tolerability and efficacy of VR according to the physiotherapists. The interviews will be recorded, written out and coded by means of grounded theory analysis in Atlas.ti. Themes and subthemes will be constructed.
10 secondary outcomes
Change in baseline performance test (guidelines KNGF) - Patient specific complaints.
Time frame: Day 0, day 42
Change in baseline performance test (guidelines KNGF) - 6 minute walk test
Time frame: Day 0, Day 42
Change in baseline performance test (guidelines KNGF) - one-repetition maximum test
Time frame: Day 0, Day 42
Change in baseline performance test (guidelines KNGF) - 30 sec sit to stand
Time frame: Day 0, Day 42
Change in baseline performance test (guidelines KNGF) - Borgscale for fatigue
Time frame: Day 0, Day 42
Change in activities of daily life.
Time frame: Day 0, Day 42
Change in HADS.
Time frame: Day 0, Day 42
Change in CFQ.
Time frame: Day 0, Day 42
Change in SF12.
Time frame: Day 0, Day 42
Change in positive health.
Time frame: Day 0, Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Derived from this study: PubMed 35858254Groenveld 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.
- Individual participant dataSharing planned: No. Only upon asking.
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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.
Harry van Goor, MD, PhD principal investigator
Radboud University Medical Center
Bart Staal, PT, PhD principal investigator
Radboud University Medical Center
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 in people with Coronavirus and Post Intensive Care Unit Syndrome, run by Radboud University Medical Center at 1 site in Netherlands.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 6 Apr 2021. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi-structured interview with 15 patients on their experiences of VR for rehabilitation from COVID-19. (time frame: Day 42). 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?
On the ClinicalTrials.gov record for NCT04505761, which also lists 1 linked publication.
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 6 Apr 2021.