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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04505761
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
Radboud University

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.


Condition or disease Intervention/treatment Phase
Coronavirus Post Intensive Care Unit Syndrome Device: Virtual Reality Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: The Usability, Feasibility, and Tolerability of Virtual Reality for Rehabilitation From COVID-19: An Explorative Study
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Intervention group
Participants will receive Virtual Reality as an add-on to standard physiotherapy after COVID-19.
Device: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Change in baseline performance test (guidelines KNGF) - Patient specific complaints. [ Time Frame: Day 0, day 42 ]

    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.


  2. Change in baseline performance test (guidelines KNGF) - 6 minute walk test [ Time Frame: Day 0, Day 42 ]

    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.


  3. Change in baseline performance test (guidelines KNGF) - one-repetition maximum test [ Time Frame: Day 0, Day 42 ]

    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.


  4. Change in baseline performance test (guidelines KNGF) - 30 sec sit to stand [ Time Frame: Day 0, Day 42 ]

    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.


  5. Change in baseline performance test (guidelines KNGF) - Borgscale for fatigue [ Time Frame: Day 0, Day 42 ]

    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.


  6. Change in activities of daily life. [ Time Frame: Day 0, Day 42 ]
    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.

  7. Change in HADS. [ Time Frame: Day 0, Day 42 ]
    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.

  8. Change in CFQ. [ Time Frame: Day 0, Day 42 ]
    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.

  9. Change in SF12. [ Time Frame: Day 0, Day 42 ]

    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.


  10. Change in positive health. [ Time Frame: Day 0, Day 42 ]

    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.



Other Outcome Measures:
  1. Patient characteristics related to use of VR [ Time Frame: Day 0 ]
    Age, gender, education, employment, lifestyle, experience with technology - qualitative measures.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04505761


Contacts
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Contact: Merlijn Smits, Msc (+31) 024-36 17612 Merlijn.smits@radboudumc.nl

Locations
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Netherlands
Radboud university medical center Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Contact: Merlijn Smits, MSc         
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Harry van Goor, MD, PhD Radboud University
Principal Investigator: Bart Staal, PT, PhD Radboud University
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04505761    
Other Study ID Numbers: COVRehab
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only upon asking.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University:
Virtual Reality
Rehabilitation
Post-intensive care syndrome
Additional relevant MeSH terms:
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Coronavirus Infections
Syndrome
Disease
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases