NCT04592757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 14, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

September 4, 2020

Last Update Submit

May 31, 2021

Conditions

Stroke

Keywords

Upper extremityRehabilitationVirtual RealityImmersive technologyMirror therapy

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (2)

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

    Immediately before and after each session.

  • 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.

Other Outcomes (3)

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

    After the last participant has finished the last session.

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

    After the last participant has finished the last session.

  • Clinicians' attitude towards VR mirror therapy

    After the last participant has finished the last session.

Study Arms (2)

Subacute stroke patients

EXPERIMENTAL

Training with new virtual mirror therapy application. During 12 sessions of approximately 30 minutes.

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.

Device: Virtual mirror therapy via VR headset

Interventions

Virtual mirror therapy via VR headsetDEVICE

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.

Also known as: VR mirror therapy, VR application, Mirror therapy
Chronic stroke patientsSubacute stroke patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Revalidatieziekenhuis RevArte

Edegem, Antwerpen, 2650, Belgium

Location

To Walk Again REVAlution Center

Herentals, Antwerpen, 2200, Belgium

Location

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Sylvie Bernaerts, PhD

    Thomas More University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

October 19, 2020

Study Start

December 14, 2020

Primary Completion

May 28, 2021

Study Completion

May 28, 2021

Last Updated

June 2, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)