Feasibility and Reliability of Using BeCureTM Virtual Reality in Patients With Stroke (cros-sectional)

November 20, 2024 updated by: Prof. Dr. Şehim Kutlay, Ankara University

Feasibility and Reliability of Using BeCureTM Virtual Reality in the Evaluation of Upper Extremity Motor Functions in Patients With Stroke

The aim of this study is to demonstrate the feasibility and reliability of using virtual reality-based BeCureTM in the assessment of upper extremity motor functions in stroke patients.It is necessary to define the appropriate patient profile for the evaluation of upper extremity motor functions in stroke patients with virtual reality method. We aimed to examine the effects of demographic characteristics, accompanying cognitive disorders and upper extremity motor disorders that may affect the evaluation and response to treatment on virtual reality applications. Therefore, BeCure TM virtual reality system can be feasibly used in the evaluation and rehabilitation of stroke patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Various motor disorders such as muscle weakness, decreased range of motion and coordination frequently occur after stroke. With the deterioration of fine and gross motor skills, especially in the upper extremities, the individual has difficulty in performing daily life activities and becomes dependent. With the introduction of advanced technologies in the field of rehabilitation, robotic rehabilitation and virtual reality applications have become widespread in our country as well as all over the world in recent years. Virtual reality allows for objective and quantitative assessment on the one hand and contributes to the rehabilitation process through serious games on the other. Virtual reality applications are frequently used in the evaluation of upper extremity functions after neurological diseases (e.g. stroke, cerebral palsy, multiple sclerosis). Virtual reality systems can allow skill-oriented exercises to be performed in a fun and safe environment while keeping the patient's interest and motivation at a high level. Thus, they can also provide access to the intensity and quality of exercise required to increase neuroplasticity. In the literature, there are studies showing that virtual reality technologies improve motor function in stroke patients. Patients with stroke may develop cognitive disorders such as attention deficit, apraxia, visual-spatial perception, neglect and memory, motor and sensory disorders, balance and posture disorders, speech and language disorders such as aphasia-dysarthria. It is necessary to define the appropriate patient profile in the evaluation of upper extremity motor functions in stroke patients with virtual reality method. The aim of this study was to examine the effects of demographic characteristics, accompanying cognitive disorders, and upper extremity motor disorders on virtual reality applications that may affect the evaluation and response to treatment. Therefore, BeCure TM virtual reality system can be feasibly used in the evaluation and rehabilitation of stroke patients.The study will be conducted in the Physical Medicine and Rehabilitation Clinic of Ankara University Faculty of Medicine Cebeci Hospital between 22.06.2024 and 22.06.2026. Volunteers who develop hemiplegia after stroke and healthy volunteers will be included in the study. Volunteers will be evaluated by Dr. Funda YAŞAR using the patient follow-up form (attached).Accordingly, sociodemographic information, history of previous computer or touchscreen phone use and gaming experience, time of diagnosis and type of lesion (ischemic or hemorrhagic), affected body half, background and dominant hand status of all volunteers, and accompanying cognitive impairments will be determined. In the subsequent physical examination, the state of consciousness, orientation and cooperation will be evaluated and mini mental test will be applied.The Mini Mental Test (MMT) is a screening test used to rapidly determine general cognitive status. The test consists of orientation, recording, attention and calculation, recall and language sections and is scored out of 30 points.The Montreal Cognitive Assessment (MoCA) scale was planned to be used to assess cognitive functions.The MoCA was developed as a rapid screening test for mild cognitive impairment. The test is a 30-point test assessing visual/spatial-administrative functions, naming, memory, attention, language, abstract thinking, recall and orientation.A score of 21 and above is considered normal.This study will include participants who can understand commands.Brunnstrom motor staging will be used for motor evaluation of the patients. This staging system consists of 3 sections: upper extremity, hand and lower extremity. The sections are graded from 1-7. A higher grade indicates a better motor stage. Volunteers with Brunnstrom upper extremity stage 3 and above will be included in the study. The Fugl-Meyer Rating Scale (FMRS) was planned to be used to assess upper extremity (UE) motor function.In our study, the UE motor function section of the FMDI will be used. UE motor function is evaluated in 4 subheadings. The total score is 66 points (0-66 points) including UE 36, wrist 10, hand 14 and coordination speed 6 points. Higher scores indicate better motor function. In UE, the motor function section is assessed in approximately 30 minutes.The Modified Ashworth Scale will be used to assess spasticity in stroke survivors.Accordingly, participants with spasticity grade 3 and above in the upper extremity will be excluded from the study because it will prevent movement in the upper extremity.The Barthel activities of daily living index is an assessment scale used to measure an individual's performance in activities of daily living.The aim of this scale is to determine to what extent the patient can perform these actions independently without any physical or verbal assistance.The 9-hole peg test assesses manual dexterity, strength, visual attention, depth perception, sensory perception and motor coordination.BIT (Behavioral Inattention Test) was planned to be used to determine the Neglect Syndrome. The patient will be given a test consisting of dividing the line in half, copying the figure and shape, drawing the depicted shape, canceling the star, drawing over the line, canceling the letter. The classical score will be 146 and the behavioral score will be evaluated out of a total of 81 points.The System Usability Scale (SUS) is a simple, ten-item Likert scale of subjective evaluations of usability.In short, it is a standardized questionnaire to measure users' satisfaction with a product or system. Developed in 1986 by John Brooke for usability evaluation. In short, it is a standardized questionnaire to measure users' satisfaction with a product or system. At the same time, a score between 0-100 can be obtained with SUS. When calculating the exact score, 1 is subtracted from the given value of items 1, 3, 5, 7 and 9 (odd numbered and positive opinion). The scores for items 2, 4, 6, 8 and 10 (items with negative opinions) are subtracted from 5. The SUS score can then be found by adding them all together and multiplying this sum by 2.5 to complete the 0-100 range.After the section including questioning and physical examination is completed, the virtual reality application phase will be started for volunteers who meet the specified inclusion criteria. The volunteers included in the study will be positioned in a sitting position at the edge of the table. BecureTM virtual reality-based Leap Ball game will be played on a laptop computer. Leap Ball is a game that can be applied in neurological diseases such as cerebral palsy, multiple sclerosis, stroke, etc. and all hand diseases. It is aimed to perform flexion/extension, adduction/abduction movements of the wrist and fingers with Leap Ball. In this application, the volunteer will be practiced 2 times and then the game will be started. In this application, the upper extremity and hand movements of the person will be reflected on the computer screen through the motion sensor (Leap Motion Controller), which is positioned on the table on the laptop screen and does not touch the volunteer. The game will start when the start button is pressed. When the patient hears the command 'hold the ball' with the instruction sound, he/she will grasp the ball and take the ball to the open hole. With the 'drop the ball' command, the patient will drop the ball into the hole. If the target number of balls enters the hole within the specified time, the game will end successfully. After the game, the completion time will be displayed on the screen. Leap ball virtual reality application takes approximately 15 minutes. In healthy volunteers who are similar in terms of age and gender, the game will be applied in both dominant and non-dominant hand, and in the group of volunteers who had a stroke, the game will be played with the hemiplegic side. The game will be repeated in the same way 7 days after the first evaluation. Patients treated in the virtual reality treatment unit will be evaluated 2 times in total. The first evaluation will be done in the process of getting used to the system. The 2nd evaluation will be done 1 week later. Subsequently, the patient will be asked to fill out the SUS scale and patient feedback questionnaire, which evaluates the applicability and reliability. The patient feedback questionnaire will be filled out by Dr. Funda Yaşar, who played the game, after the 2nd evaluation, by face-to-face interviews with the patients to evaluate their thoughts about the game system. MMT, MoCA, Nine hole peg test was planned to be performed in healthy volunteers. Dominant and non-dominant extremities will be evaluated with the Nine Hole peg test. A virtual reality game will be played on the dominant and non-dominant extremity and the time to finish the game will be recorded. SUS and patient feedback questionnaire will be completed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey, 06620
        • Recruiting
        • Ankara University School of Medicine Department of Physical Medicine and Rehabilitation
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Post-stroke patients consecutively admitted to Ankara University Faculty of Medicine, Department of Physical Medicine and Rehabilitation will be included in the study.

Description

Inclusion Criteria:

  1. Patients diagnosed with stroke according to the World Health Organization with an age range of 18-80 years
  2. Patients with subacute to chronic stroke
  3. Patients who can understand commands
  4. Patients with sitting balance
  5. Patients with a first stroke attack
  6. Patients who have never received virtual reality therapy
  7. Upper extremity Brunnstrom Stage III and above
  8. Patients with a spasticity level below 3 according to the Modified Ashworth Scale (MAS) in the affected upper extremity (MAS 1-5 rating system)
  9. Patients who agreed to participate in the study and signed the informed consent form

Exclusion Criteria:

  1. History of seizures or epilepsy (except childhood febrile seizures),
  2. Arthritis or pain in the affected upper limb that limits repetitive exercise,
  3. Severe aphasia, cognitive impairment (premorbid dementia) or psychiatric disorders,
  4. Spasticity in the affected arm is 3 or more compared to MAS,
  5. Patients without sitting balance,
  6. Patients with posterior cerebral artery infarction,
  7. Patients with subarachnoid hemorrhage,
  8. Patients with visual impairments that may affect the virtual reality application

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patient group
Post-stroke patients
Diagnostic test: Feasibility and reliability of using BeCureTM Virtual Reality in the evaluation of upper extremity motor functions in stroke patients
The applicability and reliability of virtual reality systems are important factors to consider. Based on this, this study aimed to investigate the feasibility of using BeCureTM virtual reality in the evaluation of upper extremity functions after stroke.The feasibility of using BeCureTM virtual reality in stroke patients will be determined according to the System Usability Scale (SUS) score.The safety of the use of BeCureTM virtual reality in stroke patients will be assessed with a patient feedback questionnaire. The relationship between the use of BeCureTM virtual reality and cognitive functions in stroke patients will be determined by the Montreal Cognitive Assessment Scale and Mini Mental State Examination.It was aimed to examine the effects of demographic characteristics, accompanying cognitive disorders and upper extremity motor disorders that may affect the evaluation and response to treatment on virtual reality applications.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The feasibility of using BeCureTM virtual reality in stroke patients will be determined according to the System Usability Scale (SUS) score.
Time Frame: Baseline and 7 days
The System Usability Scale (SUS) is a simple, ten-item Likert scale of subjective evaluations of usability. It was developed in 1986 by John Brooke for usability evaluation. In short, it is a standardized questionnaire to measure users' satisfaction with a product or system. At the same time, a score between 0-100 can be obtained with SUS. When calculating the exact score, 1 is subtracted from the given value of items 1, 3, 5, 7 and 9 (odd numbered and positive opinion). The scores for items 2, 4, 6, 8 and 10 (items with negative opinions) are subtracted from 5. The SUS score can then be found by adding them all together and multiplying this sum by 2.5 to complete the 0-100 range. The minimum score is 0 points and the maximum score is 100 points. A higher score indicates better usability.
Baseline and 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
1- A patient feedback questionnaire on the safety of BeCureTM virtual reality use will be completed.
Time Frame: Baseline and 7 days
  1. Patient feedback questionnaire will be completed for the reliability of BeCureTM virtual reality use in stroke patients.
  2. The relationship between the use of BeCureTM virtual reality and cognitive functions in stroke patients will be determined by the Montreal Cognitive Assessment Scale and Mini Mental State Examination.
Baseline and 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sehim Kutlay, Professor, Ankara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • I06-427-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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