Immersive Care - Virtual Mirror Therapy

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Virtual mirror therapy via VR headset

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Revalidatieziekenhuis RevArte
    • Herentals, Antwerpen, Belgium, 2200
      • To Walk Again REVAlution Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subacute stroke patients; Training with new virtual mirror therapy application. During 12 sessions of approximately 30 minutes.	Device: Virtual mirror therapy via VR headset; 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.; Other Names: Mirror therapy; VR mirror therapy; VR application
Experimental: Chronic stroke patients; Training with new virtual mirror therapy application. During 12 sessions of approximately 30 minutes.	Device: Virtual mirror therapy via VR headset; 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.; Other Names: Mirror therapy; VR mirror therapy; VR application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Immediately after finishing the last session.
Therapy adherence	Measure therapy adherence by registering the number of fully completed 30 min sessions.	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).	Immediately after finishing the first and last session.
Adverse event tracking	Qualitative tracking of adverse events by patient observation scheme.	Up to 30 minutes during each session.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 10 minutes before the start of the first session and immediately after end of the last session.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinicians' assessment of usability: System Usability Scale (SUS)	Assessment of ease of use of the VR application 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.	After the last participant has finished the last session.
Clinicians' satisfaction: Client Satisfaction Scale (CSQ-3)	Assessment of client satisfaction with the VR application with the Client Satisfaction Scale (CSQ-3). The CSQ-3 consists of 3 items with four response options and returns scores ranging from 3 to 12. Higher scores indicate higher satisfaction.	After the last participant has finished the last session.
Clinicians' attitude towards VR mirror therapy	Assess clinicians' attitude towards technology with the Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire. The UTAUT questionnaire survey for end-users consists of 31 items with five response options ranging from "Totally disagree" to "Totally agree", and returns scores ranging from 31 to 155. The questionnaire survey consists of 7 subscales, for most of which higher scores indicate a more positive attitude towards the VR mirror therapy.	After the last participant has finished the last session.

Collaborators and Investigators

• Sponsor: Thomas More University of Applied Sciences
• Collaborators: Revalidatieziekenhuis RevArte; To Walk Again REVAlution Center
• Investigators: Principal Investigator: Sylvie Bernaerts, PhD, Thomas More University of Applied Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Actual): May 28, 2021
• Study Completion (Actual): May 28, 2021

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Upper extremity; Virtual Reality; Mirror therapy; Immersive technology
• Other Study ID Numbers: IC_REHAB_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No