Feasibility and Reliability of Using BeCureTM Virtual Reality in Patients With Stroke
cros-sectional
1 other identifier
observational
34
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 22, 2024
CompletedFirst Submitted
Initial submission to the registry
November 14, 2024
CompletedFirst Posted
Study publicly available on registry
November 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 22, 2026
November 22, 2024
November 1, 2024
2 years
November 14, 2024
November 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The feasibility of using BeCureTM virtual reality in stroke patients will be determined according to the System Usability Scale (SUS) score.
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 Outcomes (1)
1- A patient feedback questionnaire on the safety of BeCureTM virtual reality use will be completed.
Baseline and 7 days
Study Arms (1)
Patient group
Post-stroke patients
Interventions
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.
Eligibility Criteria
Post-stroke patients consecutively admitted to Ankara University Faculty of Medicine, Department of Physical Medicine and Rehabilitation will be included in the study.
You may qualify if:
- Patients diagnosed with stroke according to the World Health Organization with an age range of 18-80 years
- Patients with subacute to chronic stroke
- Patients who can understand commands
- Patients with sitting balance
- Patients with a first stroke attack
- Patients who have never received virtual reality therapy
- Upper extremity Brunnstrom Stage III and above
- Patients with a spasticity level below 3 according to the Modified Ashworth Scale (MAS) in the affected upper extremity (MAS 1-5 rating system)
- Patients who agreed to participate in the study and signed the informed consent form
You may not qualify if:
- History of seizures or epilepsy (except childhood febrile seizures),
- Arthritis or pain in the affected upper limb that limits repetitive exercise,
- Severe aphasia, cognitive impairment (premorbid dementia) or psychiatric disorders,
- Spasticity in the affected arm is 3 or more compared to MAS,
- Patients without sitting balance,
- Patients with posterior cerebral artery infarction,
- Patients with subarachnoid hemorrhage,
- Patients with visual impairments that may affect the virtual reality application
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara University School of Medicine Department of Physical Medicine and Rehabilitation
Ankara, 06620, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sehim Kutlay, Professor
Ankara University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Doctor
Study Record Dates
First Submitted
November 14, 2024
First Posted
November 20, 2024
Study Start
June 22, 2024
Primary Completion (Estimated)
June 22, 2026
Study Completion (Estimated)
June 22, 2026
Last Updated
November 22, 2024
Record last verified: 2024-11