Clinical trial NCT04592757: Immersive Care - Virtual Mirror Therapy
Official title: Immersive Care - Virtual Mirror Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Upper extremity
Rehabilitation
Virtual Reality
Immersive technology
Mirror therapy
Lead sponsor: Thomas More University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Revalidatieziekenhuis RevArte
name: To Walk Again REVAlution Center
First posted: 2020-10-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change from baseline in patient attitude towards the VR mirror therapy
timeFrame: Before the start of the first session and immediately after finishing the last session.
measure: Usability of the VR mirror therapy: System Usability Scale (SUS)
timeFrame: Immediately after finishing the last session.
measure: Patient satisfaction: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Immediately after finishing the last session.
measure: Therapy adherence
timeFrame: Immediately after finishing each session.
measure: Change from baseline in tolerability (Do participants experience symptoms of simulator sickness?)
timeFrame: Immediately after finishing the first and last session.
measure: Adverse event tracking
timeFrame: Up to 30 minutes during each session.
Secondary outcomes:
measure: Changes in pain levels from pre-to-post intervention session: Visual Analogue Scale
timeFrame: Immediately before and after each session.
measure: Change from baseline in functionality of the upper limb
timeFrame: Up to 10 minutes before the start of the first session and immediately after end of the last session.
Other outcomes:
measure: Clinicians' assessment of usability: System Usability Scale (SUS)
timeFrame: After the last participant has finished the last session.
measure: Clinicians' satisfaction: Client Satisfaction Scale (CSQ-3)
timeFrame: After the last participant has finished the last session.
measure: Clinicians' attitude towards VR mirror therapy
timeFrame: After the last participant has finished the last session.
Locations:
city: Edegem
country: Belgium
facility: Revalidatieziekenhuis RevArte
state: Antwerpen
city: Herentals
country: Belgium
facility: To Walk Again REVAlution Center
state: Antwerpen
Study officials:
affiliation: Thomas More University of Applied Sciences
name: Sylvie Bernaerts, PhD
role: PRINCIPAL_INVESTIGATOR
References: