StrokeNCT04592757
Immersive Care - Virtual Mirror Therapy
A study testing Virtual mirror therapy via VR headset in people with Stroke, run by Thomas More University of Applied Sciences at 2 sites in Belgium.
Trial summary
The purpose of this implementation study is - primarily - to investigate the feasibility, acceptability, tolerability of a new virtual reality application in stroke patients, and -secondarily - to gain initial insights in the preliminary clinical effects of this application. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual mirror therapy via VR headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesBelgium
- Study dates
- 14 Dec 2020to 28 May 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke patients in the subacute or chronic phase, aged between 18 and 85 years old with a normal functioning upper limb on the unaffected side and a reduced use and / or weakness and / or paralysis of the upper limb on the affected side
- Ability to sit on a chair or in a wheelchair with adequate trunk stability so that the unaffected upper limb can move freely
- Ability to follow verbal instructions
- Ability to communicate verbally with the researchers
Who cannot join
- Stroke patients in acute phase
- Severe medical conditions that interfere with the proper execution of the research
- Patients who are medically unstable
- Cognitive disorders which may complicate the research or make it impossible
- Speaking disorders (aphasia, dysarthria) which may complicate the proper execution of the research and the communication of important verbal information
- Visual disorders which complicate carrying out ADL activities or make it impossible
Show all 11Show fewer
- Known allergies to any of the materials of the VR headset
- Epilepsy
- Extreme sensitivity to motion sickness
- Specific anxiety disorders that hinder the use of the VR headset such as claustrophobia
- Skin diseases or lesions in the contact area of the VR headset
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Revalidatieziekenhuis RevArte
Edegem, Antwerpen, 2650
To Walk Again REVAlution Center
Herentals, Antwerpen, 2200
About this study
The purpose of this implementation study is - primarily - to investigate the feasibility, acceptability, tolerability of a new virtual reality application in stroke patients, and -secondarily - to gain initial insights in the preliminary clinical effects of this application.
Read the detailed description
Although immersive technologies have great potential in healthcare, they are still relatively unknown and underutilized in this field. In this study a new virtual reality (VR) application will be implemented and tested in two groups of stroke patients (10 acute phase/10 chronic phase). In an attempt to reactivate the affected upper limb in stroke patients, therapists often use mirror therapy. Using a mirror, the movement of a paralyzed limb is feigned in order to reprogram the brain. A patient performs exercises with the healthy limb, but through the mirror the patient seems to use the affected limb. A high number of repetitions is essential to stimulate the so-called neuroplasticity of the brain, but this makes mirror therapy monotonous. In addition, the therapy also has its limitations. Activities are limited by the physical boundaries of the modality, with exercises largely limited to distal movements and simple functional activities. Larger, free-standing mirrors provide a wider range of motion for therapeutic activities, but offer less protection against environmental distraction. With VR, these obstacles can be overcome. By focusing on virtual mirror therapy using a VR headset, therapists hope to create a more pleasant and realistic experience for the patients.
- Conditions
- Stroke
- Being tested
- Virtual mirror therapy via VR headset
- Keywords
- Upper extremity, Rehabilitation, Virtual Reality, Immersive technology, Mirror therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual mirror therapy via VR headsetDevice
Also called VR mirror therapy, VR application, Mirror therapy
Participants will perform Activities of Daily Living (ADL) in a virtual environment through a VR headset. The application is based on mirror therapy. Participants will execute certain arm movements with their non-affected arm, while seeing their affected arm perform said movement in the virtual environment.
| Study group | Role | What they receive |
|---|---|---|
| Subacute stroke patients | Experimental | Training with new virtual mirror therapy application. During 12 sessions of approximately 30 minutes. Receives: Device: Virtual mirror therapy via VR headset |
| Chronic stroke patients | Experimental | Training with new virtual mirror therapy application. During 12 sessions of approximately 30 minutes. Receives: Device: Virtual mirror therapy via VR headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in patient attitude towards the VR mirror therapy
Assess change in patient attitude towards the VR mirror therapy with the Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire survey. The UTAUT questionnaire survey for end-users consists of 20 items with five response options ranging from "Totally disagree" (1) to "Totally agree" (5), and returns scores ranging from 20 to 100. The questionnaire survey consists of 7 subscales, for most of which higher scores indicate a more positive attitude towards the VR mirror therapy.
Measured: Before the start of the first session and immediately after finishing the last session.
Usability of the VR mirror therapy: System Usability Scale (SUS)
Assessment of ease of use of the VR mirror therapy with the System Usability Scale (SUS). The SUS is a 10-item questionnaire with five response options for respondents; from "strongly disagree" to "strongly agree", and returns scores ranging from 0 to 100. A higher SUS score indicates better usability.
Measured: Immediately after finishing the last session.
Patient satisfaction: Client Satisfaction Questionnaire (CSQ-8)
Assessment of client satisfaction with the VR application with the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 consists of 8 items with four response options and returns scores ranging from 8 to 32. Higher scores indicate higher satisfaction.
Measured: Immediately after finishing the last session.
Therapy adherence
Measure therapy adherence by registering the number of fully completed 30 min sessions.
Measured: Immediately after finishing each session.
Change from baseline in tolerability (Do participants experience symptoms of simulator sickness?)
Assessment of physical side effects after exposure to VR by the Simulator Sickness Questionnaire (SSQ).
Measured: Immediately after finishing the first and last session.
Adverse event tracking
Qualitative tracking of adverse events by patient observation scheme.
Measured: Up to 30 minutes during each session.
Secondary outcomes (2)
Changes in pain levels from pre-to-post intervention session: Visual Analogue Scale
Assessment of changes in pain using a Visual Analogue Scale ranging from 0 = no pain at all, to 100 = most pain imaginable.
Measured: Immediately before and after each session.
Change from baseline in functionality of the upper limb
Assessment of changes in the functionality of the upper limb with the Fugl-Meyer upper extremity (FMUE) assessment. The FMUE Scale comprises 33 items, each scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully.
Measured: Up to 10 minutes before the start of the first session and immediately after end of the last session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start14 Dec 2020
- Primary completion28 May 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas More University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Revalidatieziekenhuis RevArte, To Walk Again REVAlution Center
- Responsible party
- Sponsor
- Investigators
- Sylvie Bernaerts, PhD, Principal investigator, Thomas More University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592757
- Sponsor's protocol ID
- IC_REHAB_01
- Status last verified
- May 2021
- First submitted
- 4 Sep 2020
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Care - Virtual Mirror Therapy
- ClinicalTrials.gov ID
- NCT04592757
- Acronym / sponsor ID
- IC_REHAB_01
- Conditions
- Stroke
- Keywords
- Upper extremity, Rehabilitation, Virtual Reality, Immersive technology, Mirror therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Thomas More University of Applied SciencesUniversity, hospital or other
- Collaborators
- Revalidatieziekenhuis RevArte, To Walk Again REVAlution Center
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 19 Oct 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.
The purpose of this implementation study is - primarily - to investigate the feasibility, acceptability, tolerability of a new virtual reality application in stroke patients, and -secondarily - to gain initial insights in the preliminary clinical effects of this application.
Detailed description
Although immersive technologies have great potential in healthcare, they are still relatively unknown and underutilized in this field. In this study a new virtual reality (VR) application will be implemented and tested in two groups of stroke patients (10 acute phase/10 chronic phase). In an attempt to reactivate the affected upper limb in stroke patients, therapists often use mirror therapy. Using a mirror, the movement of a paralyzed limb is feigned in order to reprogram the brain. A patient performs exercises with the healthy limb, but through the mirror the patient seems to use the affected limb. A high number of repetitions is essential to stimulate the so-called neuroplasticity of the brain, but this makes mirror therapy monotonous. In addition, the therapy also has its limitations. Activities are limited by the physical boundaries of the modality, with exercises largely limited to distal movements and simple functional activities. Larger, free-standing mirrors provide a wider range of motion for therapeutic activities, but offer less protection against environmental distraction. With VR, these obstacles can be overcome. By focusing on virtual mirror therapy using a VR headset, therapists hope to create a more pleasant and realistic experience for the patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subacute stroke patients | Experimental | Device: Virtual mirror therapy via VR headsetTraining with new virtual mirror therapy application. During 12 sessions of approximately 30 minutes. |
| Chronic stroke patients | Experimental | Device: Virtual mirror therapy via VR headsetTraining with new virtual mirror therapy application. During 12 sessions of approximately 30 minutes. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stroke patients in the subacute or chronic phase, aged between 18 and 85 years old with a normal functioning upper limb on the unaffected side and a reduced use and / or weakness and / or paralysis of the upper limb on the affected side
- Ability to sit on a chair or in a wheelchair with adequate trunk stability so that the unaffected upper limb can move freely
- Ability to follow verbal instructions
- Ability to communicate verbally with the researchers
Key exclusion criteria (11 listed)
- Stroke patients in acute phase
- Severe medical conditions that interfere with the proper execution of the research
- Patients who are medically unstable
- Cognitive disorders which may complicate the research or make it impossible
- Speaking disorders (aphasia, dysarthria) which may complicate the proper execution of the research and the communication of important verbal information
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 mirror therapy via VR headsetAlso: VR mirror therapy, VR application, Mirror therapyParticipants will perform Activities of Daily Living (ADL) in a virtual environment through a VR headset. The application is based on mirror therapy. Participants will execute certain arm movements with their non-affected arm, while seeing their affected arm perform said movement in the virtual environment. | Device | Chronic stroke patients, Subacute stroke patients |
Primary outcome
Change from baseline in patient attitude towards the VR mirror therapy
Time frame: Before the start of the first session and immediately after finishing the last session.
Assess change in patient attitude towards the VR mirror therapy with the Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire survey. The UTAUT questionnaire survey for end-users consists of 20 items with five response options ranging from "Totally disagree" (1) to "Totally agree" (5), and returns scores ranging from 20 to 100. The questionnaire survey consists of 7 subscales, for most of which higher scores indicate a more positive attitude towards the VR mirror therapy.
Usability of the VR mirror therapy: System Usability Scale (SUS)
Time frame: Immediately after finishing the last session.
Assessment of ease of use of the VR mirror therapy with the System Usability Scale (SUS). The SUS is a 10-item questionnaire with five response options for respondents; from "strongly disagree" to "strongly agree", and returns scores ranging from 0 to 100. A higher SUS score indicates better usability.
Patient satisfaction: Client Satisfaction Questionnaire (CSQ-8)
Time frame: Immediately after finishing the last session.
Assessment of client satisfaction with the VR application with the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 consists of 8 items with four response options and returns scores ranging from 8 to 32. Higher scores indicate higher satisfaction.
Therapy adherence
Time frame: Immediately after finishing each session.
Measure therapy adherence by registering the number of fully completed 30 min sessions.
Change from baseline in tolerability (Do participants experience symptoms of simulator sickness?)
Time frame: Immediately after finishing the first and last session.
Assessment of physical side effects after exposure to VR by the Simulator Sickness Questionnaire (SSQ).
Adverse event tracking
Time frame: Up to 30 minutes during each session.
Qualitative tracking of adverse events by patient observation scheme.
2 secondary outcomes
Changes in pain levels from pre-to-post intervention session: Visual Analogue Scale
Time frame: Immediately before and after each session.
Change from baseline in functionality of the upper limb
Time frame: Up to 10 minutes before the start of the first session and immediately after end of the last session.
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 2 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Sylvie Bernaerts, PhD principal investigator
Thomas More University of Applied Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual mirror therapy via VR headset in people with Stroke, run by Thomas More University of Applied Sciences at 2 sites in Belgium.
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 4 inclusion and 11 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 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Change from baseline in patient attitude towards the VR mirror therapy (time frame: Before the start of the first session and immediately after finishing the last session.). The study lists 6 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 2 Jun 2021.