Stroke
Conditions
Keywords
Upper extremity, Rehabilitation, Virtual Reality, Immersive technology, Mirror therapy
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.
Interventions
DEVICEVirtual 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.
Sponsors
Revalidatieziekenhuis RevArte
To Walk Again REVAlution Center
Thomas More University of Applied Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event tracking | Up to 30 minutes during each session. | Qualitative tracking of adverse events by patient observation scheme. |
| Change from baseline in patient attitude towards the VR mirror therapy | 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) | 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) | 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 | 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?) | Immediately after finishing the first and last session. | Assessment of physical side effects after exposure to VR by the Simulator Sickness Questionnaire (SSQ). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in pain levels from pre-to-post intervention session: Visual Analogue Scale | 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. |
| Change from baseline in functionality of the upper limb | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinicians' satisfaction: Client Satisfaction Scale (CSQ-3) | 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. |
| Clinicians' attitude towards VR mirror therapy | 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. |
| Clinicians' assessment of usability: System Usability Scale (SUS) | 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. |
Countries
Belgium
Outcome results
None listed