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Completed

NCT Number: NCT04592757

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Revalidatieziekenhuis RevArte, Edegem, Antwerpen, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual mirror therapy via VR headset

Device

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: VR mirror therapy, VR application, Mirror therapy

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Therapy adherence

    Time frame: Immediately after finishing each session.

    Measure therapy adherence by registering the number of fully completed 30 min sessions.

  5. 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).

  6. Adverse event tracking

    Time frame: Up to 30 minutes during each session.

    Qualitative tracking of adverse events by patient observation scheme.

Secondary outcomes

  1. Changes in pain levels from pre-to-post intervention session: Visual Analogue Scale

    Time frame: Immediately before and after each session.

    Assessment of changes in pain using a Visual Analogue Scale ranging from 0 = no pain at all, to 100 = most pain imaginable.

  2. 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.

    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.

Other outcomes

  1. Clinicians' assessment of usability: System Usability Scale (SUS)

    Time frame: After the last participant has finished the last session.

    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.

  2. Clinicians' satisfaction: Client Satisfaction Scale (CSQ-3)

    Time frame: After the last participant has finished the last session.

    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.

  3. Clinicians' attitude towards VR mirror therapy

    Time frame: After the last participant has finished the last session.

    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.

Sponsors and collaborators

Lead sponsor

Thomas More University of Applied Sciences

Other

Collaborators

  • Revalidatieziekenhuis RevArte
  • To Walk Again REVAlution Center

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2020
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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